Results Summary
What was the research about?
Doctors often prescribe opioids to treat chronic pain that lasts for months or years. But these medicines can be risky. Patients may misuse, become addicted to, or take too many opioids at once. Increasing patients’ activation, or their ability to manage their health, may be one way to lower opioid risks while helping patients manage their pain.
In this study, the research team tested a program to improve patient activation for patients who use prescription opioids to manage chronic pain. The program included group sessions with a therapist on topics like
- Taking an active role in managing pain
- Managing pain without opioids
- Using online patient portals and other technology to help manage care
- Talking with doctors about ways to manage pain
The research team also wanted to see if this program improved patients’ mental and physical health and their use of healthcare resources and opioids, compared to patients that weren’t in the program.
What were the results?
After 12 months, the research team found no difference in patient activation between patients who were in the program and those who weren’t. But patients in the program reported
- Fewer cases of moderate to severe depression
- Better physical and mental health
- Better ability to cope with pain through exercise
- Higher rates of using an online portal to check lab results and access health resources
Patients who were in the program and those that weren’t reduced their prescription opioid use by a similar amount.
Who was in the study?
The study included 376 patients with chronic pain who received care at two large primary care clinics in California. Patients had been taking opioids about three times per week for at least three months. Of these patients, 68 percent were white, 17 percent were Hispanic, 5 percent were African American, 5 percent were Asian, and 4 percent were Native American. The average age was 60, and 58 percent were women.
What did the research team do?
The research team assigned about half the patients by chance to a program that taught activation and pain management skills. Patients in the program went to four 90-minute group sessions with a therapist. They still got usual care from their doctors. The other half of the patients received usual care from their doctors.
The research team talked to patients by phone and looked at their health records 6 and 12 months after the study began.
What were the limits of the study?
The study only included patients in the program who could attend the sessions in person. The results may not apply to those who can’t attend in-person sessions, like patients with more complex health problems.
Future studies could test ways to use the program with those who can’t attend in person, such as online or by smartphone. Future research could also test programs to help doctors talk with patients about opioids and other ways to manage pain.
How can people use the results?
Clinics can consider these results when looking at ways to lower the risks of opioid use for patients with chronic pain.
Professional Abstract
Objective
To determine whether a group-based behavioral pain management intervention in primary care increases patient activation among patients prescribed opioids for chronic pain compared with usual care alone
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 376 adult patients with chronic pain treated in primary care with opioid medication at least 3 times a week for 3 months |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient activation Secondary: patient self-report of depression, quality of life, overall health, pain intensity, functional status, satisfaction with care, prescription opioid misuse, pain coping strategies, self-efficacy, patient-provider communication, alcohol and drug use, and prescription opioid use; EHR-based measures of use of patient portals and prescription opioid use |
| Timeframe | 1-year follow-up for primary outcome |
This randomized controlled trial compared the effect of ACTIVATE, a group-based behavioral pain management intervention plus usual primary care, with usual care alone on patient activation and other physical, mental, and behavioral outcomes. Patient activation is having the knowledge, skills, beliefs, and confidence to manage one’s own health and health care. Using elements of education, motivational interviewing, cognitive behavioral therapy, and mindfulness, the research team developed the ACTIVATE intervention to empower patients to take a greater role in managing chronic pain and communicating with clinicians about prescription opioid use.
The research team randomly assigned patients to the ACTIVATE or usual-care-only study arms. Both arms received routine care from their clinicians. Patients in ACTIVATE also attended a psychologist-led series of four weekly 90-minute in-person group sessions. The goal of the sessions was to help patients learn to take an active role in pain management and overall health. Patients also learned pain management skills, including how to use online patient portals and other technology for self-care, and about communication strategies to talk with clinicians.
The research team conducted telephone interviews to assess patient activation and other patient self-reported outcomes 6 and 12 months after randomization. The team also examined patient electronic health records (EHRs) to learn about patients’ healthcare use.
The study included 376 adult patients with chronic pain who had received a prescription to use opioid medication at least three times a week for three months. Of these patients, 68% were white, 17% were Hispanic, 5% were African American, 5% were Asian, and 4% were Native American. The average age was 60, and 58% were female. All patients received care at two large primary care clinics in northern California.
Patients, clinicians, patient advocates, and researchers helped create ACTIVATE, recruit participants, and interpret results.
Results
After 12 months, patient activation did not differ between the ACTIVATE and usual-care arms. Compared with patients in the usual-care arm, patients in ACTIVATE had
- Lower likelihood of moderate-to-severe depression (p=0.02)
- Higher rating of physical health status (p=0.01)
- Higher rating of overall health (p=0.02)
- Higher use of exercise to cope with pain (p=0.02)
- Higher likelihood of self-reported and EHR-based use of a patient portal for checking lab results (p=0.01) and accessing health and wellness resources (p=0.04)
The two arms did not differ in other study outcomes.
Limitations
The study only included patients who could attend the sessions in person. Thus, findings do not reflect the experiences of patients who could not attend, such as patients with more complex health problems.
Conclusions and Relevance
Although the intervention did not improve patient activation in patients prescribed opioids for chronic pain, it improved other outcomes, including physical and mental health and frequency of practicing alternative pain-coping methods.
Future Research Needs
Future research could develop a parallel intervention to help clinicians communicate with patients about pain, opioids, and alternatives for pain management. Future studies could also test alternate versions of the ACTIVATE intervention—either online or via smartphone—for those who cannot attend in-person sessions.
Final Research Report
View this project's final research report.
Engagement Resources
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- The reviewers said the study should emphasize the lack of significant effects in the primary outcome measure before discussing any significant findings in secondary outcomes. The researchers updated the report to do so.
- The reviewers noted that given the large number of secondary outcomes measured, positive results should be interpreted with caution. In particular, they expressed concern because the analyses for these outcomes were not adjusted for multiple comparisons. The researchers revised the report to highlight null results and introduce additional notes of caution.
- The reviewers recommended including additional detail to help explain the meaningfulness of the results, beyond stating the statistical significance with a P value. The researchers added 95% confidence intervals for the key outcome estimates, providing more precision around the significance of the results. The researchers noted that many of their patient-reported scales did not have clinically relevant units that could be reported.
- Some reviewers expressed concern that the study encouraged chronic care patients to curtail opioid use, which might not be clinically appropriate. The researchers responded that their intervention did not make clinical recommendations and did not aim to discourage opioid use. The researchers explained that instead they aimed to empower patients to communicate with providers and explore alternative ways to manage pain. The researchers said they used input from patient advisors in trying to develop a balanced curriculum for their intervention.