Chronic PainNCT02290223
Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
A study testing Behavioral Based Treatment Model in people with Chronic Pain, run by Kaiser Permanente at 2 sites in United States.
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Behavioral Based Treatment Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to 6 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente, San Jose Medical Center
San Jose, California, 95119
Kaiser Permanente, Santa Clara Medical Center
Santa Clara, California, 95051
About this study
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?
Read the detailed 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.
- Conditions
- Chronic Pain
- Being tested
- Behavioral Based Treatment Model
- Keywords
- Chronic pain, Analgesics, Opioid, Cognitive Therapy, Behavior Therapy, Mindfulness, Psychophysiology, Biofeedback, Psychology
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Based Treatment ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Based Treatment Model |
| Usual Care | No intervention | Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 and 12 months post randomization
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 and 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJun 2015
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (79)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Cynthia I Campbell, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290223
- Sponsor's protocol ID
- CN-14-1928-H
- Status last verified
- Sep 2019
- First submitted
- 27 Oct 2014
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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/
PubMed 22553896Gureje O, Simon GE, Von Korff M. A cross-national study of the course of persistent pain in primary care. Pain. 2001 May;92(1-2):195-200. doi: 10.1016/s0304-3959(00)00483-8.
PubMed 11323140Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.
PubMed 19718704Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004 Jun;109(3):514-519. doi: 10.1016/j.pain.2004.03.006.
PubMed 15157714Ballantyne JC. Pain medicine: repairing a fractured dream. Anesthesiology. 2011 Feb;114(2):243-6. doi: 10.1097/ALN.0b013e3182039f87. No abstract available.
PubMed 21239973Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.
PubMed 19124635Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011 Aug 23;343:d5142. doi: 10.1136/bmj.d5142. No abstract available.
PubMed 21862533Grady D, Berkowitz SA, Katz MH. Opioids for chronic pain. Arch Intern Med. 2011 Sep 12;171(16):1426-7. doi: 10.1001/archinternmed.2011.213. Epub 2011 Jun 13. No abstract available.
PubMed 21670333Katz MH. Long-term opioid treatment of nonmalignant pain: a believer loses his faith. Arch Intern Med. 2010 Sep 13;170(16):1422-4. doi: 10.1001/archinternmed.2010.335. No abstract available.
PubMed 20837826McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010 Jan 19;152(2):123-4. doi: 10.7326/0003-4819-152-2-201001190-00012. No abstract available.
PubMed 20083830Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available.
PubMed 21083382Sullivan MD. Limiting the potential harms of high-dose opioid therapy: comment on "Opioid dose and drug-related mortality in patients with nonmalignant pain". Arch Intern Med. 2011 Apr 11;171(7):691-3. doi: 10.1001/archinternmed.2011.101. No abstract available.
PubMed 21482847Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5):325-8. doi: 10.7326/0003-4819-155-5-201109060-00011.
PubMed 21893626Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009 Feb;10(2):131-46. doi: 10.1016/j.jpain.2008.10.009.
PubMed 19187890Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O'Connor PG, Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009 Feb;10(2):113-30. doi: 10.1016/j.jpain.2008.10.008.
PubMed 19187889
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
- ClinicalTrials.gov ID
- NCT02290223
- Acronym / sponsor ID
- CN-14-1928-H
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Analgesics, Opioid, Cognitive Therapy, Behavior Therapy, Mindfulness, Psychophysiology, Biofeedback, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jun 2015 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Activation Group Intervention | Experimental | Behavioral: Behavioral Based Treatment ModelThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Based Treatment ModelBehavioral 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. | Behavioural | Patient Activation Group Intervention |
Primary outcome
Patient Activation
Time frame: Baseline and 6 and 12 months post randomization
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.
26 secondary outcomes
Quality of Life: Physical Health
Time frame: Baseline and 6 and 12 months post randomization
Quality of Life: Mental Health
Time frame: Baseline and 6 and 12 months post randomization
Overall Health
Time frame: Baseline and 6 and 12 months post randomization
PHQ-9 Depression
Time frame: Baseline and 6 and 12 months post randomization
Satisfaction With Care
Time frame: Baseline and 6 and 12 months post randomization
Opioid Misuse SOAPP
Time frame: Baseline and 6 and 12 months post randomization
Opioid Misuse COMM
Time frame: Baseline and 6 and 12 months post randomization
Pain Coping
Time frame: 6 and 12 months post randomization
Self-Efficacy
Time frame: Baseline and 6 and 12 months post randomization
Pain Intensity
Time frame: Baseline and 6 and 12 months post randomization
Function: Everyday Physical Activities
Time frame: Baseline and 6 and 12 months post randomization
Function: Social Activities and Roles
Time frame: Baseline and 6 and 12 months post randomization
Patient Provider Communication
Time frame: Baseline and 6 and 12 months post randomization
Patient Provider Interactions
Time frame: Baseline and 6 and 12 months post randomization
Health Care Utilization Service Visits (EHR)
Time frame: Baseline and 6 and 12 months post randomization
Health Care Utilization Portal Use (EHR)
Time frame: Baseline and 6 and 12 months post randomization
Use of Online Health and Wellness Resources (Self-reported)
Time frame: Baseline and 6 and 12 months post randomization
Attendance at Health Education Classes (Self-reported)
Time frame: Baseline and 6 and 12 months post randomization
Prescription Opioid Use (EHR)
Time frame: Baseline and 6 and 12 months post randomization
Pain Management Strategies- Mindfulness, Meditation and Relaxation
Time frame: Baseline and 6 and 12 months post randomization
Pain Management Strategies- Exercise, Stretching or Physical Therapy
Time frame: Baseline and 6 and 12 months post randomization
Goals for Opioid Use at Baseline
Time frame: baseline
Met Baseline Goals for Opioid Use at 6 and 12 Months
Time frame: 6 and 12 months post-randomization
Substance Use
Time frame: Baseline and 6 and 12 month post-randomization
Alcohol Use
Time frame: Baseline and 6 and 12 months post-randomization
Tobacco Use
Time frame: Baseline and 6 and 12 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22553896Institute 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/
- Background: PubMed 11323140Gureje O, Simon GE, Von Korff M. A cross-national study of the course of persistent pain in primary care. Pain. 2001 May;92(1-2):195-200. doi: 10.1016/s0304-3959(00)00483-8.
- Background: PubMed 19718704Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.
- Background: PubMed 15157714Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004 Jun;109(3):514-519. doi: 10.1016/j.pain.2004.03.006.
- Background: PubMed 21239973Ballantyne JC. Pain medicine: repairing a fractured dream. Anesthesiology. 2011 Feb;114(2):243-6. doi: 10.1097/ALN.0b013e3182039f87. No abstract available.
- Background: PubMed 19124635Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.
- Background: PubMed 21862533Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011 Aug 23;343:d5142. doi: 10.1136/bmj.d5142. No abstract available.
- Background: PubMed 21670333Grady D, Berkowitz SA, Katz MH. Opioids for chronic pain. Arch Intern Med. 2011 Sep 12;171(16):1426-7. doi: 10.1001/archinternmed.2011.213. Epub 2011 Jun 13. No abstract available.
- Background: PubMed 20837826Katz MH. Long-term opioid treatment of nonmalignant pain: a believer loses his faith. Arch Intern Med. 2010 Sep 13;170(16):1422-4. doi: 10.1001/archinternmed.2010.335. No abstract available.
- Background: PubMed 20083830McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010 Jan 19;152(2):123-4. doi: 10.7326/0003-4819-152-2-201001190-00012. No abstract available.
- Background: PubMed 21083382Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available.
- Background: PubMed 21482847Sullivan MD. Limiting the potential harms of high-dose opioid therapy: comment on "Opioid dose and drug-related mortality in patients with nonmalignant pain". Arch Intern Med. 2011 Apr 11;171(7):691-3. doi: 10.1001/archinternmed.2011.101. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia I Campbell, PhD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Based Treatment Model in people with Chronic Pain, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: Baseline and 6 and 12 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290223, which also lists 79 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.