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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA044970-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.
In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain self-management | Experimental | This intervention will have 4 components:
|
|
| usual care | Active Comparator | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain self-management training | Behavioral | This intervention will have 4 components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | 12 months after randomization |
| Pain, Enjoyment of Life, and General Activity (PEG) Score | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | 6 months after randomization |
| Pain, Enjoyment of Life, and General Activity (PEG) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Sullivan, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington | Seattle | Washington | 98112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27908840 | Background | Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28. | |
| 37624901 | Derived | Wartko PD, Krakauer C, Turner JA, Cook AJ, Boudreau DM, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Pain. 2023 Dec 1;164(12):2852-2864. doi: 10.1097/j.pain.0000000000002982. Epub 2023 Aug 25. |
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Availability of data and materials: The datasets generated and analyzed during the current study are not publicly available to protect participant privacy. Deidentified analysis datasets may be made available upon email request to the corresponding author. Any data shared may require an application with description of the planned research purpose and an execution of a data use agreement with approval from the KPWA IRB overseeing this trial. Further, if the researcher would also like the R analysis code used for this manuscript, they can request this at the time of requesting the deidentified analysis dataset.
Data will be available after January 30, 2023 until January 30, 2028
Availability of data and materials: The datasets generated and analyzed during the current study are not publicly available to protect participant privacy. Deidentified analysis datasets may be made available upon email request to the corresponding author. Any data shared may require an application with description of the planned research purpose and an execution of a data use agreement with approval from the KPWA IRB overseeing this trial. Further, if the researcher would also like the R analysis code used for this manuscript, they can request this at the time of requesting the deidentified analysis dataset.
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Using electronic health records and claims data, 1381 individuals fulfilled a subset of study inclusion criteria and were contacted to assess further inclusion criteria. 170 of these individuals fulfilled all inclusion criteria, as determined using two phone screenings and were contacted to participate in the study. 153 of these individuals returned a baseline questionnaire and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pain Self-Management | This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components:
|
| FG001 | Usual Care | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pain Self-Management | This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components:
|
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | MME/day | 12 months after randomization |
|
Data were collected for 12 months, ending at participants' final follow up time point.
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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 | Pain Self-Management | This arm includes patients Patients randomized to Pain self-management training; This intervention will have 4 components:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain after PMR | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Sullivan | University of Washington | 2066853184 | sullimar@uw.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 | Jun 7, 2021 | Feb 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2020 | Jan 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D058007 | Physicians, Primary Care |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Patients are individually randomized to pain self-management training for opioid taper or usual care. Those randomized to pain self-management training will be offered assistance with opioid taper during approximately the fourth session of pain self-management training.
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Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.
|
|
| video education, motivational interviewing | Behavioral | web-based video of successfully tapered patients with motivational interviewing debriefing |
|
|
| voluntary self-paced opioid taper | Behavioral | Voluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they will negotiate details with their primary care provider. |
|
|
| prescribing guidance for primary care provider | Behavioral | Based upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper. All prescriptions will be written by the primary care provider. |
|
|
| usual care | Other | Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses |
|
|
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
| 6 months after randomization |
| Pain Self-Efficacy Questionnaire (PSEQ) Score | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. | 6 months after randomization |
| Pain Self-Efficacy Questionnaire (PSEQ) Score | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. | 12 months after randomization |
| Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | 6 months after randomization |
| Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | 12 months after randomization |
| Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | 6 months after randomization |
| Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | 12 months after randomization |
| Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | 6 months after randomization |
| Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | 12 months after randomization |
| Prescription Opioid Misuse Index (POMI) Score | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. | 6 months after randomization |
| Prescription Opioid Misuse Index (POMI) Score | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. | 12 months after randomization |
| Prescription Opioid Difficulties Scale (PODS) Score | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. | 6 months after randomization |
| Prescription Opioid Difficulties Scale (PODS) Score | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. | 12 months after randomization |
| Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | 6 months after randomization |
| Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | 12 months after randomization |
| At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | 6 months after randomization |
| At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | 12 months after randomization |
| 34217889 | Derived | Wartko PD, Boudreau DM, Turner JA, Cook AJ, Wellman RD, Fujii MM, Garcia RC, Moser KA, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2. |
| BG001 | Usual Care | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Daily Opioid Morphine Milligram Equivalents (MME) | Average over the 30 days prior to baseline of the prescribed daily morphine milligram equivalents (MME). | Mean | Standard Deviation | MME/day |
|
| Pain, Enjoyment of Life, and General Activity (PEG) Score | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. | Mean | Standard Deviation | score on a scale |
|
| Pain Self-Efficacy Questionnaire (PSEQ) Score | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | Mean | Standard Deviation | score on a scale |
|
| Generalized Anxiety Disorder-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | Mean | Standard Deviation | score on a scale |
|
| Prescription Opioid Misuse Index (POMI) Score | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. | Mean | Standard Deviation | score on a scale |
|
| Prescribed Opioids Difficulties Scale (PODS) Score | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. | Mean | Standard Deviation | score on a scale |
|
| Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Usual Care | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
|
|
|
| Primary | Pain, Enjoyment of Life, and General Activity (PEG) Score | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. | Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | MME/day | 6 months after randomization |
|
|
|
|
| Secondary | Pain, Enjoyment of Life, and General Activity (PEG) Score | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. | Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Pain Self-Efficacy Questionnaire (PSEQ) Score | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. | Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Pain Self-Efficacy Questionnaire (PSEQ) Score | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. | Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | Randomized individuals with completed PHQ-8 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Prescription Opioid Misuse Index (POMI) Score | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. | Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Prescription Opioid Misuse Index (POMI) Score | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. | Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Prescription Opioid Difficulties Scale (PODS) Score | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. | Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Prescription Opioid Difficulties Scale (PODS) Score | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. | Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after randomization |
|
|
|
|
| Secondary | Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after randomization |
|
|
|
|
| Secondary | At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models. | Posted | Number | participants | 6 months after randomization |
|
|
|
|
| Secondary | At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models. | Posted | Number | participants | 12 months after randomization |
|
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 8 |
| 79 |
| EG001 | Usual Care | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. | 0 | 74 | 0 | 74 | 0 | 74 |
| Headache after PMR | Nervous system disorders | Non-systematic Assessment |
|
| Stopped taking prescribed opioids | General disorders | Non-systematic Assessment |
|
| Increased anxiety / anger when reminded of appointment with study staff | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D010820 | Physicians |
| D006282 | Health Personnel |