Patient Activation to Address Chronic Pain and Opioid Management in Primary Care

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Patient Activation to Address Chronic Pain and Opioid Management in Primary Care

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Behavioral Based Treatment Model


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients aged 18+ who receive primary care at the Kaiser Permanente Santa Clara or San Jose Medical Center study clinic Patients who have been using prescription opioids for pain at least three days per week over the past three months.47,48,60 Exclusion criteria: Patients who have any other more serious comorbidity than their pain (e.g., terminal illness, active cancer, high risk for/currently with uncontrolled addictions or severe mental health issues such as psychosis), or impairing ability to engage with interventions Patients who are already treated in pain clinic Patients who are already treated in chemical dependency treatment Patients who do not read and understand English Patients planning to taper or stop taking prescription opioids in next 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Activation Group Intervention<br>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. | Behavioral: Behavioral Based Treatment Model<br>* 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.<br>|
| No Intervention: Usual Care<br>Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Analgesics, Opioid, Cognitive Therapy, Behavior Therapy, Mindfulness, Psychophysiology, Biofeedback, Psychology