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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290223
• Other study ID #: CN-14-1928-H
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 6, 2017

Study information

• Verified date: September 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Patients aged 18+ who receive primary care at the Kaiser Permanente Santa Clara or San Jose Medical Center study clinic

2. 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:

1. 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

2. Patients who are already treated in pain clinic

3. Patients who are already treated in chemical dependency treatment

4. Patients who do not read and understand English

5. Patients planning to taper or stop taking prescription opioids in next 30 days

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Behavioral Based Treatment Model
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente, San Jose Medical Center	San Jose	California
United States	Kaiser Permanente, Santa Clara Medical Center	Santa Clara	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 78 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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).	Baseline and 6 and 12 months post randomization
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).	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	Baseline and 6 and 12 months post randomization
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.	baseline
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".	6 and 12 months post-randomization
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.	Baseline and 6 and 12 month post-randomization
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.	Baseline and 6 and 12 months post-randomization
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.	Baseline and 6 and 12 months post-randomization