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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Will a primary care-based behavioral intervention for patient activation and engagement and self-management, for patients with chronic pain who are taking opioid pain medication, result in better patient outcomes than Usual Care?
Patients with chronic pain (PWCP) typically have multiple chronic conditions, and many points of contact with the health system. They can feel disempowered, and experience fragmented care and poor outcomes. PWCP report concerns about under-treatment of pain, difficulties in obtaining medication, and stigma. Prescription opioids are a very common, and controversial, pain treatment. PWCP often lack the skills and knowledge to talk to their physicians about their pain and opioid use, and to navigate the health care system. The study's aims compare the effectiveness of an innovative behavioral Patient Activation plus Usual Care (PA+UC) intervention to Usual Care (UC) only on patient-centered outcomes among PWCP. While most studies have focused on chronic opioid users, this takes an upstream approach, focusing on patients as they start regular opioid use. The overarching research question is: Can patients' increased activation improve their quality of life? With our stakeholder group of patient, clinical, and operational advisors, we propose a pragmatic, randomized trial to examine the comparative effectiveness of a group-based PA intervention in two large primary care clinics in Kaiser Permanente Northern California (KPNC). We will randomize 324 PWCP to either the PA+UC arm or UC only arm. The curriculum will cover patient activation and empowerment, how to talk to doctors about prescription opioid use, and self-management of chronic pain, including how to navigate the health care system and a patient portal. We will further develop the study questions, intervention curriculum, outcome measures, and dissemination plan with our stakeholder groups. We will examine effects over 12 months using follow-up patient interviews combined with electronic health records and a mixed effects modeling approach. Patient outcomes include patient-reported activation, quality of life, prescription opioid use, pain severity and function, patient-provider communication, patient satisfaction, knowledge of opioid use risks and benefits, self-care, including use of health information technology, and service utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Activation Group Intervention | Experimental | The experimental procedure is a behavioral based treatment model, plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
|
| Usual Care | No Intervention | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Based Treatment Model | Behavioral | Behavioral based treatment consists of four 90 minute group sessions, one meeting per week. The sessions addressed: empowering patients to take an active role in pain management and overall health; pain management lifestyle practices; use of health information technology resources for active self-care; education on neurobiology of pain and opioids; and improving communication with providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation | The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence. | Baseline and 6 and 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: Physical Health | The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Physical Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population. |
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Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia I Campbell, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente, San Jose Medical Center | San Jose | California | 95119 | United States | ||
| Kaiser Permanente, Santa Clara Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22553896 | Background | Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/ | |
| 11323140 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Activation Group Intervention | The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week. |
| FG001 | Usual Care | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 6 Months |
| |||||||||||||
| 12 Months |
|
There were 376 enrolled in study and 189 assigned to intervention arm and 187 to usual care at baseline appointment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Activation Group Intervention | The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week. |
| 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 | Patient Activation | The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence. | Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
|
Adverse events were assessed for each participant between the date of their baseline interview and the date of their 12 month follow up interview.
The electronic medical records for all study participants were reviewed during the period of active participation (between baseline interview and 12 month follow up interview). All deaths and hospitalizations were identified, discharge notes were reviewed and reason for death/hospitalizations were categorized. An Independent Safety Monitor reviewed records and determined that no serious adverse events or mortalities were related in any way to the conduct of the study.
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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 | Patient Activation Group Intervention | The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Does, Project Manager | Kaiser NCAL Division of Research | 510-891-3612 | monique.does@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2016 | Jan 17, 2018 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 16, 2018 | Sep 24, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2018 | Sep 24, 2019 | SAP_002.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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| Baseline and 6 and 12 months post randomization |
| Quality of Life: Mental Health | The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Mental Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population. | Baseline and 6 and 12 months post randomization |
| Overall Health | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Measure of overall health is based on a single item/rating: "In general, would you say your health is:". Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning. | Baseline and 6 and 12 months post randomization |
| PHQ-9 Depression | Depression was measured using the Patient Health Questionnaire-9 (PHQ-9), a reliable and well validated instrument. Mean scores are reported in range 0-27, with higher score indicating severity of depression: mild (5-9), moderate (10-14), moderately severe (15-19) and over 20 indicating severe depression. | Baseline and 6 and 12 months post randomization |
| Satisfaction With Care | Satisfaction with primary care provider is reported on a scale from 1-10, where "1" is the worst possible care and "10" is the best possible care. Mean scores are reported, and higher scores indicates more satisfaction with care. | Baseline and 6 and 12 months post randomization |
| Opioid Misuse SOAPP | The Screener and Opioid Assessment for Patients in Pain (SOAPP-5) is a 5 item survey used to identify aberrant behaviors related to long-term opioid treatment. Each item is rated 0 to 4 (with 0=never and 4=very often); ratings are added for all 5 items resulting in a range of possible scores 0-20. A higher score indicates greater risk for patients on long term opioids, and a score of => 4 is considered positive. Results reported are the number and % of participants who score => 4. | Baseline and 6 and 12 months post randomization |
| Opioid Misuse COMM | The Current Opioid Misuse Measure (COMM) is used to identify aberrant behaviors related to long-term opioid treatment. It is a clinical screening tool for monitoring patients for opioid overuse and misuse in six areas. The COMM contains 17 items with total score range of 0-68, and a score of 9 or greater is considered positive. It uses a low cut off value as it is intended to over-identify misuse. Results reported are the number and % of participants who score => 9. | Baseline and 6 and 12 months post randomization |
| Pain Coping | The 42-item Chronic Pain Coping Inventory (CPCI) is used to assess behavioral and cognitive pain coping strategies. It contains 8 subscales: Guarding, Resting, Asking for Assistance, Relaxation, Task Persistence, Exercising/Stretching, Coping Self-Statements, and Seeking Social Support. For each subscale, patients were asked the number of days (0-7 days) he/she performed each task (4-7 tasks). The mean score for each subscale is reported, with possible range of scores 0-7. The CPCI was developed to assess the behavioral coping strategies that are taught and encouraged during treatment (eg, relaxation, exercising, task persistence), ones that are discouraged (eg, guarding, resting, asking for assistance), and one neutral strategy (seeking social support). Active strategies are defined as adaptive coping responses (eg, staying busy or active), and higher scores are associated with positive coping. | 6 and 12 months post randomization |
| Self-Efficacy | Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical settings to assess confidence in one's ability to work and lead a normal life despite pain. Each item is rated on a 7-point scale with 0= not at all confident and 6=extremely confident. A total score is calculated by summing the scores for each of 10 items, yielding max score of 60. A higher score indicates higher self-efficacy. | Baseline and 6 and 12 months post randomization |
| Pain Intensity | Measured with the Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument. PROMIS is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Pain intensity is assessed using a single item ("How would you rate your pain, on average?"). The average raw score is reported on scale 1-10, with 1=no pain to 10= worst imaginable. | Baseline and 6 and 12 months post randomization |
| Function: Everyday Physical Activities | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair?" Answers are reported on scale 1-5, with 1=not at all to 5=completely. Average raw scores are reported, with higher scores reflecting higher functioning. | Baseline and 6 and 12 months post randomization |
| Function: Social Activities and Roles | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.)" Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning. | Baseline and 6 and 12 months post randomization |
| Patient Provider Communication | The Communication Assessment Tool (CAT) measures patients' perceptions of physician performance with regard to communication and interpersonal skills. It is a 14-item instrument that asks respondents to rate their primary primary care physician based on the last couple of visits. The answers are reported using a 5-point rating scale, with 1=poor to 5=excellent. Average scores are reported. | Baseline and 6 and 12 months post randomization |
| Patient Provider Interactions | The Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) is used to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians.Ten questions are measured on a scale from 1 (not at all confident) to 5 (very confident) and the range of possible scores is 10-50. Average scores are reported, with higher score reflecting more confidence in interacting with his/her physician. | Baseline and 6 and 12 months post randomization |
| Health Care Utilization Service Visits (EHR) | Primary care services (number of non-urgent outpatient visits) and acute care services (number of emergency room (ER) visits and inpatient stays) within KPNC as extracted from the electronic health records are reported. Average number of visits are reported for 6 month period prior to baseline, for 3 months prior to 6 month interview, and 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | Baseline and 6 and 12 months post randomization |
| Health Care Utilization Portal Use (EHR) | Use of Kaiser's online portal is extracted from electronic health record. Results are reported as number and % of patients who used the portal during specified time periods: 1) 6 month period prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | Baseline and 6 and 12 months post randomization |
| Use of Online Health and Wellness Resources (Self-reported) | Use of Kaiser's online portal (kp.org) was reported by participants on questionnaire at baseline, 6 and 12 months. Participants were asked different ways in which portal was used, and if they used kp.org's health and wellness resources (healthy lifestyle programs, wellness coaching, audio podcasts, recipe blogs, tools/calculators, videos). Results reported here are number and % of patients who reported using Kaiser's online health and wellness resources during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months). | Baseline and 6 and 12 months post randomization |
| Attendance at Health Education Classes (Self-reported) | Attendance at Kaiser's health education classes was reported by participants on questionnaire at baseline, 6 and 12 months. Results are reported as number and % of patients who attended health education class during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months). | Baseline and 6 and 12 months post randomization |
| Prescription Opioid Use (EHR) | Opioid prescription dispensations were extracted from electronic health records and converted into morphine milligram equivalent (MME), by multiplying the quantity of each prescription by the strength of prescription (milligrams of opioid/unit dispensed). The resulting product is then multiplied by the conversion factor for MMEs. We calculated the average daily MME dispensed for the relevant time periods. Results are reported for 3 time periods: 1) 6 months prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all 3 time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | Baseline and 6 and 12 months post randomization |
| Pain Management Strategies- Mindfulness, Meditation and Relaxation | Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "mindfulness, meditation and relaxation". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported. | Baseline and 6 and 12 months post randomization |
| Pain Management Strategies- Exercise, Stretching or Physical Therapy | Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "exercise, stretching or physical therapy". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported. | Baseline and 6 and 12 months post randomization |
| Goals for Opioid Use at Baseline | Participants were asked at baseline about their long-term goals for using prescription opioids for pain management. Results are presented as number and percent who wanted to stay the same/increase use, and number and percent who wanted to decrease or stop use of prescription opioids. | baseline |
| Met Baseline Goals for Opioid Use at 6 and 12 Months | Participants were asked at 6 and12 months to what extent they felt they met goals for opioid use stated at baseline. Results are presented as number and percent who reported "to a great extent"/"somewhat", vs. "very little"/"not al all". | 6 and 12 months post-randomization |
| Substance Use | Participants were asked about 9 categories of substance use in past 3 months, based on NIDA-modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Results are reported as number and percent for three categories: prescription/street opioids, cannabis and sedatives/sleeping pills. Remaining categories (cocaine, methamphetamines, stimulants, inhalants) were collapsed into "other" category. | Baseline and 6 and 12 month post-randomization |
| Alcohol Use | The number and percent of participants who report "heavy drinking" in past 3 months are reported at baseline and 6 and 12 months. Heavy drinking is defined as 5+ drinks per day or 15+ drinks per week for males under age 65, and 4+ drinks per day or 8+ drinks per week for females and males over age 65. | Baseline and 6 and 12 months post-randomization |
| Tobacco Use | Participants were asked how many days they had smoked cigarettes in past 30 days at baseline, 6 and 12 months. Results are reported as number and percent who reported they smoked cigarettes on at least one day in past 30 days. | Baseline and 6 and 12 months post-randomization |
| Santa Clara |
| California |
| 95051 |
| United States |
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| 23440672 | Background | Debar LL, Kindler L, Keefe FJ, Green CA, Smith DH, Deyo RA, Ames K, Feldstein A. A primary care-based interdisciplinary team approach to the treatment of chronic pain utilizing a pragmatic clinical trials framework. Transl Behav Med. 2012 Dec 1;2(4):523-530. doi: 10.1007/s13142-012-0163-2. Epub 2012 Aug 30. |
| 24281273 | Background | Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. Clin J Pain. 2014 Jul;30(7):557-64. doi: 10.1097/AJP.0000000000000021. |
| 18028043 | Background | Edlund MJ, Sullivan M, Steffick D, Harris KM, Wells KB. Do users of regularly prescribed opioids have higher rates of substance use problems than nonusers? Pain Med. 2007 Nov-Dec;8(8):647-56. doi: 10.1111/j.1526-4637.2006.00200.x. |
| 18950440 | Background | Brown JL, Edwards PS, Atchison JW, Lafayette-Lucey A, Wittmer VT, Robinson ME. Defining patient-centered, multidimensional success criteria for treatment of chronic spine pain. Pain Med. 2008 Oct;9(7):851-62. doi: 10.1111/j.1526-4637.2007.00357.x. |
| 15102235 | Background | Casarett D, Karlawish J, Sankar P, Hirschman K, Asch DA. Designing pain research from the patient's perspective: what trial end points are important to patients with chronic pain? Pain Med. 2001 Dec;2(4):309-16. doi: 10.1046/j.1526-4637.2001.01041.x. |
| 14659516 | Background | Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001. |
| 23836747 | Background | Greene J, Hibbard JH, Sacks R, Overton V. When seeing the same physician, highly activated patients have better care experiences than less activated patients. Health Aff (Millwood). 2013 Jul;32(7):1299-305. doi: 10.1377/hlthaff.2012.1409. |
| Background | National Research Council. Health Literacy: A Prescription to End Confusion. Washington, DC: The National Academies Press; 2004. http://www.nap.edu/catalog.php?record_id=10883. Accessed January 19, 2014 |
| Background | Pain Survey Executive Summary. Massachusetts Pain Initiative. 2010. http://www.masspaininitiative.org/files/MassPI%20Pain%20Survey%20-%20Executive%20Summary%20v3.pdf. Updated August 15, 2013. Accessed January 18, 2014. |
| 22827502 | Background | Kline-Simon AH, Falk DE, Litten RZ, Mertens JR, Fertig J, Ryan M, Weisner CM. Posttreatment low-risk drinking as a predictor of future drinking and problem outcomes among individuals with alcohol use disorders. Alcohol Clin Exp Res. 2013 Jan;37 Suppl 1(0 1):E373-80. doi: 10.1111/j.1530-0277.2012.01908.x. Epub 2012 Jul 24. |
| 11594896 | Background | Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating primary medical care with addiction treatment: a randomized controlled trial. JAMA. 2001 Oct 10;286(14):1715-23. doi: 10.1001/jama.286.14.1715. |
| Background | Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988 |
| 17634969 | Background | Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46. doi: 10.1002/sim.2980. |
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| 17060538 | Background | Sullivan MD, Edlund MJ, Zhang L, Unutzer J, Wells KB. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med. 2006 Oct 23;166(19):2087-93. doi: 10.1001/archinte.166.19.2087. |
| 11055449 | Background | Weisner C, Mertens J, Parthasarathy S, Moore C, Hunkeler EM, Hu T, Selby JV. The outcome and cost of alcohol and drug treatment in an HMO: day hospital versus traditional outpatient regimens. Health Serv Res. 2000 Oct;35(4):791-812. |
| 19728074 | Background | Green CA, Perrin NA, Polen MR, Leo MC, Hibbard JH, Tusler M. Development of the Patient Activation Measure for mental health. Adm Policy Ment Health. 2010 Jul;37(4):327-33. doi: 10.1007/s10488-009-0239-6. Epub 2009 Aug 29. |
| 16336556 | Background | Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x. |
| 15230939 | Background | Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x. |
| 17170635 | Background | Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9. doi: 10.1097/00004479-200701000-00005. |
| 18030539 | Background | Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21. |
| 19060254 | Background | Camacho FT, Feldman SR, Balkrishnan R, Kong MC, Anderson RT. Validation and reliability of 2 specialty care satisfaction scales. Am J Med Qual. 2009 Jan-Feb;24(1):12-8. doi: 10.1177/1062860608326416. Epub 2008 Dec 5. |
| Background | PROMIS Network Center. PROMIS (Patient Reported Outcome Measurement Information System). USA.gov. http://www.nihpromis.org/?AspxAutoDetectCookieSupport=1#3. Accessed January 18, 2014 |
| Background | Broderick JE, DeWitt EM, Rothrock N, Crane PK, Forrest CB. Advances in patient reported outcomes: The NIH PROMIS measures. eGEMs (Generating Evidence & Methods to improve patient outcomes). 2013;Volume1(Issue 1, Article 12). http://repository.academyhealth.org/cgi/viewcontent.cgi?article=1015&context=egems. Accessed January 19, 2014 |
| 22034123 | Background | Hinchcliff M, Beaumont JL, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D. Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1620-8. doi: 10.1002/acr.20591. |
| 22422138 | Background | Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao JC. Comparison of health-related quality of life in patients with neuroendocrine tumors with quality of life in the general US population. Pancreas. 2012 Apr;41(3):461-6. doi: 10.1097/MPA.0b013e3182328045. |
| 23497200 | Background | Flynn KE, Reeve BB, Lin L, Cyranowski JM, Bruner DW, Weinfurt KP. Construct validity of the PROMIS(R) sexual function and satisfaction measures in patients with cancer. Health Qual Life Outcomes. 2013 Mar 11;11:40. doi: 10.1186/1477-7525-11-40. |
| 23387911 | Background | Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex Med. 2013 Feb;10 Suppl 1(0 1):43-52. doi: 10.1111/j.1743-6109.2012.02995.x. |
| 10109801 | Background | EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. |
| 23815777 | Background | Obradovic M, Lal A, Liedgens H. Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain. Health Qual Life Outcomes. 2013 Jul 1;11:110. doi: 10.1186/1477-7525-11-110. |
| 17574367 | Background | Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18. |
| 18571875 | Background | Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20. |
| 18574361 | Background | Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b. |
| 23381517 | Result | Bernabeo E, Holmboe ES. Patients, providers, and systems need to acquire a specific set of competencies to achieve truly patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):250-8. doi: 10.1377/hlthaff.2012.1120. |
| 38254073 | Derived | Does MB, Adams SR, Kline-Simon AH, Marino C, Charvat-Aguilar N, Weisner CM, Rubinstein AL, Ghadiali M, Cowan P, Young-Wolff KC, Campbell CI. A patient activation intervention in primary care for patients with chronic pain on long term opioid therapy: results from a randomized control trial. BMC Health Serv Res. 2024 Jan 22;24(1):112. doi: 10.1186/s12913-024-10558-3. |
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| BG001 | Usual Care | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
| BG002 | Total | Total of all reporting groups |
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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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| Patient Activation Measure | Patient Activation Measure (PAM) is a 13-item validated instrument for measuring patient beliefs, knowledge, and confidence for engaging in a wide range of health behaviors.The PAM-13 is measured on a 1-100 scale, with higher score representing higher level of activation. | Mean | Standard Deviation | units on a scale |
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| Pain intensity | PROMIS pain intensity question ("How would you rate your pain, on average?") is used to measure pain level. Average raw scores are reported on scale 1-10, with 1=no pain to 10= worst imaginable. | Mean | Standard Deviation | units on a scale |
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| OG001 | Usual Care | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
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| Secondary | Quality of Life: Physical Health | The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Physical Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population. | Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | T score | Baseline and 6 and 12 months post randomization |
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| Secondary | Quality of Life: Mental Health | The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Mental Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population. | Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | T score | Baseline and 6 and 12 months post randomization |
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| Secondary | Overall Health | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Measure of overall health is based on a single item/rating: "In general, would you say your health is:". Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | PHQ-9 Depression | Depression was measured using the Patient Health Questionnaire-9 (PHQ-9), a reliable and well validated instrument. Mean scores are reported in range 0-27, with higher score indicating severity of depression: mild (5-9), moderate (10-14), moderately severe (15-19) and over 20 indicating severe depression. | Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | score | Baseline and 6 and 12 months post randomization |
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| Secondary | Satisfaction With Care | Satisfaction with primary care provider is reported on a scale from 1-10, where "1" is the worst possible care and "10" is the best possible care. Mean scores are reported, and higher scores indicates more satisfaction with care. | Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Opioid Misuse SOAPP | The Screener and Opioid Assessment for Patients in Pain (SOAPP-5) is a 5 item survey used to identify aberrant behaviors related to long-term opioid treatment. Each item is rated 0 to 4 (with 0=never and 4=very often); ratings are added for all 5 items resulting in a range of possible scores 0-20. A higher score indicates greater risk for patients on long term opioids, and a score of => 4 is considered positive. Results reported are the number and % of participants who score => 4. | The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month SOAPP are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC). | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Opioid Misuse COMM | The Current Opioid Misuse Measure (COMM) is used to identify aberrant behaviors related to long-term opioid treatment. It is a clinical screening tool for monitoring patients for opioid overuse and misuse in six areas. The COMM contains 17 items with total score range of 0-68, and a score of 9 or greater is considered positive. It uses a low cut off value as it is intended to over-identify misuse. Results reported are the number and % of participants who score => 9. | The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month COMM are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC). | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Pain Coping | The 42-item Chronic Pain Coping Inventory (CPCI) is used to assess behavioral and cognitive pain coping strategies. It contains 8 subscales: Guarding, Resting, Asking for Assistance, Relaxation, Task Persistence, Exercising/Stretching, Coping Self-Statements, and Seeking Social Support. For each subscale, patients were asked the number of days (0-7 days) he/she performed each task (4-7 tasks). The mean score for each subscale is reported, with possible range of scores 0-7. The CPCI was developed to assess the behavioral coping strategies that are taught and encouraged during treatment (eg, relaxation, exercising, task persistence), ones that are discouraged (eg, guarding, resting, asking for assistance), and one neutral strategy (seeking social support). Active strategies are defined as adaptive coping responses (eg, staying busy or active), and higher scores are associated with positive coping. | For brevity purposes, the baseline values are not included in the table (n=189 intervention and n=187usual care). There were 354 participants included in the 6 mo analysis (n=173 intervention and n=181 usual care) and 342 participants in 12 mo analysis (n=166 intervention and n=176 usual care). | Posted | Mean | Standard Deviation | units on a scale | 6 and 12 months post randomization |
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| Secondary | Self-Efficacy | Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical settings to assess confidence in one's ability to work and lead a normal life despite pain. Each item is rated on a 7-point scale with 0= not at all confident and 6=extremely confident. A total score is calculated by summing the scores for each of 10 items, yielding max score of 60. A higher score indicates higher self-efficacy. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Pain Intensity | Measured with the Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument. PROMIS is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Pain intensity is assessed using a single item ("How would you rate your pain, on average?"). The average raw score is reported on scale 1-10, with 1=no pain to 10= worst imaginable. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Function: Everyday Physical Activities | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair?" Answers are reported on scale 1-5, with 1=not at all to 5=completely. Average raw scores are reported, with higher scores reflecting higher functioning. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Function: Social Activities and Roles | The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.)" Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Patient Provider Communication | The Communication Assessment Tool (CAT) measures patients' perceptions of physician performance with regard to communication and interpersonal skills. It is a 14-item instrument that asks respondents to rate their primary primary care physician based on the last couple of visits. The answers are reported using a 5-point rating scale, with 1=poor to 5=excellent. Average scores are reported. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Patient Provider Interactions | The Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) is used to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians.Ten questions are measured on a scale from 1 (not at all confident) to 5 (very confident) and the range of possible scores is 10-50. Average scores are reported, with higher score reflecting more confidence in interacting with his/her physician. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 and 12 months post randomization |
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| Secondary | Health Care Utilization Service Visits (EHR) | Primary care services (number of non-urgent outpatient visits) and acute care services (number of emergency room (ER) visits and inpatient stays) within KPNC as extracted from the electronic health records are reported. Average number of visits are reported for 6 month period prior to baseline, for 3 months prior to 6 month interview, and 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes. | Posted | Mean | Standard Deviation | visits | Baseline and 6 and 12 months post randomization |
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| Secondary | Health Care Utilization Portal Use (EHR) | Use of Kaiser's online portal is extracted from electronic health record. Results are reported as number and % of patients who used the portal during specified time periods: 1) 6 month period prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Use of Online Health and Wellness Resources (Self-reported) | Use of Kaiser's online portal (kp.org) was reported by participants on questionnaire at baseline, 6 and 12 months. Participants were asked different ways in which portal was used, and if they used kp.org's health and wellness resources (healthy lifestyle programs, wellness coaching, audio podcasts, recipe blogs, tools/calculators, videos). Results reported here are number and % of patients who reported using Kaiser's online health and wellness resources during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months). | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Attendance at Health Education Classes (Self-reported) | Attendance at Kaiser's health education classes was reported by participants on questionnaire at baseline, 6 and 12 months. Results are reported as number and % of patients who attended health education class during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months). | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Prescription Opioid Use (EHR) | Opioid prescription dispensations were extracted from electronic health records and converted into morphine milligram equivalent (MME), by multiplying the quantity of each prescription by the strength of prescription (milligrams of opioid/unit dispensed). The resulting product is then multiplied by the conversion factor for MMEs. We calculated the average daily MME dispensed for the relevant time periods. Results are reported for 3 time periods: 1) 6 months prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all 3 time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis. | EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes. | Posted | Mean | Standard Deviation | MME | Baseline and 6 and 12 months post randomization |
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| Secondary | Pain Management Strategies- Mindfulness, Meditation and Relaxation | Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "mindfulness, meditation and relaxation". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Pain Management Strategies- Exercise, Stretching or Physical Therapy | Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "exercise, stretching or physical therapy". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post randomization |
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| Secondary | Goals for Opioid Use at Baseline | Participants were asked at baseline about their long-term goals for using prescription opioids for pain management. Results are presented as number and percent who wanted to stay the same/increase use, and number and percent who wanted to decrease or stop use of prescription opioids. | Posted | Count of Participants | Participants | baseline |
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| Secondary | Met Baseline Goals for Opioid Use at 6 and 12 Months | Participants were asked at 6 and12 months to what extent they felt they met goals for opioid use stated at baseline. Results are presented as number and percent who reported "to a great extent"/"somewhat", vs. "very little"/"not al all". | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | 6 and 12 months post-randomization |
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| Secondary | Substance Use | Participants were asked about 9 categories of substance use in past 3 months, based on NIDA-modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Results are reported as number and percent for three categories: prescription/street opioids, cannabis and sedatives/sleeping pills. Remaining categories (cocaine, methamphetamines, stimulants, inhalants) were collapsed into "other" category. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. Categories do not add up to number analyzed because answer were "check all that apply" and multiple answers per respondent were allowed. | Posted | Number | participants who used given substance | Baseline and 6 and 12 month post-randomization |
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| Secondary | Alcohol Use | The number and percent of participants who report "heavy drinking" in past 3 months are reported at baseline and 6 and 12 months. Heavy drinking is defined as 5+ drinks per day or 15+ drinks per week for males under age 65, and 4+ drinks per day or 8+ drinks per week for females and males over age 65. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post-randomization |
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| Secondary | Tobacco Use | Participants were asked how many days they had smoked cigarettes in past 30 days at baseline, 6 and 12 months. Results are reported as number and percent who reported they smoked cigarettes on at least one day in past 30 days. | Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. | Posted | Count of Participants | Participants | Baseline and 6 and 12 months post-randomization |
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| 2 |
| 189 |
| 16 |
| 189 |
| 0 |
| 189 |
| EG001 | Usual Care | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. | 1 | 187 | 26 | 187 | 0 | 187 |
| Diastolic heart failure | Cardiac disorders | Systematic Assessment |
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| Heart failure due to pulmonary hypertension | Cardiac disorders | Systematic Assessment |
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| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
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| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Hernia repair | Gastrointestinal disorders | Systematic Assessment |
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| Chronic pain | General disorders | Systematic Assessment |
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| Opioid withdrawal | General disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Post surgery Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | Systematic Assessment |
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| Meningocephalitis | Nervous system disorders | Systematic Assessment |
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| Normal delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Acute pyelonephritis | Renal and urinary disorders | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Gastic bypass | Surgical and medical procedures | Systematic Assessment |
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| Hip arthoplasty | Surgical and medical procedures | Systematic Assessment |
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| Joint fusion | Surgical and medical procedures | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | Systematic Assessment |
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| Laminotomy | Surgical and medical procedures | Systematic Assessment |
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| Shoulder arthoplasty | Surgical and medical procedures | Systematic Assessment |
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| Left leg ischemia | Vascular disorders | Systematic Assessment |
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Not provided
Not provided
| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 12 month Guarding |
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| 6 month Resting |
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| 12 month Resting |
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| 6 month Asking for assistance |
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| 12 month Asking for assistance |
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| 6 month Relaxation |
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| 12 month Relaxation |
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| 6 month Task persistence |
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| 12 month Task persistence |
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| 6 month Exercise/stretching |
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| 12 month Exercise/stretching |
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| 6 month Seeking social support |
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| 12 month Seeking social support |
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| 6 month Coping self-statements |
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| 12 month Coping self-statements |
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| 6 months |
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| 12 months |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month primary care visits |
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| 12 month primary care visits |
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| baseline ER visits |
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| 6 month ER visits |
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| 12 month ER visits |
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| baseline Inpatient stays |
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| 6 month Inpatient stays |
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| 12 month Inpatient stays |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| Very little/not at all |
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| missing |
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| 12 months |
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| Baseline substance use : Sedatives/sleeping pills |
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| Baseline substance use : Opioids |
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| Baseline substance use : Other |
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| 6 month substance use : Cannabis |
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| 6 month substance use : Sedatives/sleeping pills |
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| 6 month substance use : Opioids |
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| 6 month substance use : Other |
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| 12 month substance use : Cannabis |
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| 12 month substance use : Sedatives/sleeping pills |
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| 12 month substance use : Opioids |
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| 12 month substance use : Other |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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