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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR001938 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Nursing Research (NINR) | NIH |
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Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment.
The purpose of the PREEMPT Study is to test whether using a mobile phone application ("Trialist app") that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trialist Intervention | Experimental | Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician. |
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| Control-Usual Care | No Intervention | Receive usual care from clinician for chronic pain, do not use Trialist smartphone app |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trialist Intervention | Behavioral | Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Kravitz, MD, MSPH | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veteran's Administration-Northern California Health Care System | Mather | California | 95655 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25881274 | Background | Barr C, Marois M, Sim I, Schmid CH, Wilsey B, Ward D, Duan N, Hays RD, Selsky J, Servadio J, Schwartz M, Dsouza C, Dhammi N, Holt Z, Baquero V, MacDonald S, Jerant A, Sprinkle R, Kravitz RL. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial. Trials. 2015 Feb 27;16:67. doi: 10.1186/s13063-015-0590-8. | |
| 34400254 | Derived | Kravitz RL, Marois M, Sim I, Ward D, Kanekar SS, Yu A, Dounias P, Yang J, Wang Y, Schmid CH. Chronic pain treatment preferences change following participation in N-of-1 trials, but not always in the expected direction. J Clin Epidemiol. 2021 Nov;139:167-176. doi: 10.1016/j.jclinepi.2021.08.007. Epub 2021 Aug 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trialist Intervention | Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician. Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects. smartphone |
| FG001 | Control-Usual Care | Receive usual care from clinician for chronic pain, do not use Trialist smartphone app |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Baseline |
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| Three Month Follow-up |
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| Six Month Follow-up |
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| Twelve Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Trialist Intervention | Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician. Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects. smartphone |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 26 weeks |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trialist Intervention | Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician. Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects. smartphone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Kravitz, MD, MSPH | University of California, Davis | 916-734-1248 | rlkravitz@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2016 | Jan 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| smartphone | Device |
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| baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks, 26 weeks, 52 weeks |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Baseline, 13 weeks, 26 weeks, 52 weeks |
| Baseline, 26 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Baseline, 26 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Baseline, 26 weeks |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Baseline, 26 weeks |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Baseline, 26 weeks |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Baseline, 26 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Baseline, 26 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Baseline, 26 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Baseline, 26 weeks |
| Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. | 26 weeks |
| Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Baseline, 13 weeks |
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Baseline, 13 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Baseline, 13 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Baseline, 13 weeks |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Baseline, 13 weeks |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Baseline, 13 weeks |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Baseline, 13 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Baseline, 13 weeks |
| Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Baseline, 52 weeks |
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Baseline, 52 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Baseline, 52 weeks |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Baseline, 52 weeks |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Baseline, 52 weeks |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Baseline, 52 weeks |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Baseline, 52 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Baseline, 52 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Baseline, 52 weeks |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Baseline, 52 weeks |
| Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. | Baseline, 52 weeks |
| University of California, Davis Medical Center |
| Sacramento |
| California |
| 95816 |
| United States |
| 31463686 | Derived | Odineal DD, Marois MT, Ward D, Schmid CH, Cabrera R, Sim I, Wang Y, Wilsey B, Duan N, Henry SG, Kravitz RL. Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain: Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):102-111. doi: 10.1007/s11606-019-05303-0. Epub 2019 Aug 28. |
| 30193253 | Derived | Kravitz RL, Schmid CH, Marois M, Wilsey B, Ward D, Hays RD, Duan N, Wang Y, MacDonald S, Jerant A, Servadio JL, Haddad D, Sim I. Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1368-1377. doi: 10.1001/jamainternmed.2018.3981. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Control-Usual Care | Receive usual care from clinician for chronic pain, do not use Trialist smartphone app |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Pain interference | Pain interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. | Mean | Standard Deviation | units on a scale |
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| Pain intensity | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. | Mean | Standard Deviation | units on a scale |
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| Global physical health | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. | Mean | Standard Deviation | units on a scale |
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| Global mental health | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. | Mean | Standard Deviation | units on a scale |
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| Analgesic adherence (overuse) | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. | Mean | Standard Deviation | units on a scale |
|
| Analgesic adherence (underuse) | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. | Mean | Standard Deviation | units on a scale |
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| Trust in clinician | Patient trust in physician measured with 11-item Trust in Physician Scale to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. | Mean | Standard Deviation | units on a scale |
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| Satisfaction with pain information | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with medical care | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with pain medication | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. | Mean | Standard Deviation | units on a scale |
|
| Medication related shared decision making | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. | Mean | Standard Deviation | units on a scale |
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| OG001 | Control-Usual Care | Receive usual care from clinician for chronic pain, do not use Trialist smartphone app |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks, 26 weeks, 52 weeks |
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| Secondary | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks, 26 weeks, 52 weeks |
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| Other Pre-specified | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 26 weeks |
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| Other Pre-specified | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 26 weeks |
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| Other Pre-specified | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 13 weeks |
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| Other Pre-specified | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| Other Pre-specified | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 52 weeks |
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| 1 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Control-Usual Care | Receive usual care from clinician for chronic pain, do not use Trialist smartphone app | 1 | 107 | 0 | 107 | 0 | 107 |
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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| Change from baseline to 52 weeks |
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