Results Summary
What was the research about?
Chronic pain is pain that lasts for months or years. Medicines called opioids can treat chronic pain. But patients who use opioids for a long time are at risk for health problems, such as addiction, overdose, and injuries. Doctors and patients don’t always talk about these risks when choosing pain treatments.
In this study, the research team compared two approaches to help patients and doctors talk about chronic pain treatments and reduce high-risk opioid use and effects of pain on patients’ lives:
- Doctors received an alert in patients' health records when prescribing opioids. The alert reminded doctors about the correct use of opioids and to offer education to patients.
- Patients received materials, including handouts and a video, online or by email before their visit. Materials encouraged patients to talk with their doctors about treatment preferences.
The research team looked at patients’ satisfaction in talking with their doctor and other health outcomes.
What were the results?
Because of study limitations, it’s hard to draw conclusions about the results.
Compared with patients whose doctors received alerts, patients who received materials were more likely to be satisfied in talking with their doctor. But they were also more likely to get an opioid prescription with a high dose.
After one year, with the available data, the two approaches didn’t differ in:
- How pain interfered with patients’ lives
- Patients’ ability to do daily activities, such as walking or dressing
- Patients’ symptoms of depression
- How likely patients were to have prescriptions for both an opioid and an anxiety medicine
Who was in the study?
The study included 951 patients who received care from one of 82 primary care doctors in a California health system. Among patients, 63 percent were White, 22 percent were Black, 6 percent were Asian, less than 1 percent were American Indian or Native Hawaiian, and 8 percent didn’t report a race; 11 percent were Hispanic. The average age was 54, and 58 percent were women. All had one or more prescriptions for opioids.
What did the research team do?
The research team assigned doctors by chance to one of the two approaches.
After each visit, the health system sent patients a survey about their satisfaction with talking to their doctor. Each month, the research team sent patients surveys about pain and their daily activities. The team compared responses before and after the health system started using each approach. For data about depression and prescriptions, the team looked at health records.
Patients with chronic pain, patient advocacy groups, and doctors helped design and carry out the study.
What were the limits of the study?
At the start of the study, patients assigned to the two approaches differed in satisfaction and opioid prescriptions. Also, less than 40 percent of patients responded to surveys. These limitations make it hard to be certain about the results.
Future research could use other methods for looking at these approaches to help patients and doctors talk about chronic pain treatments.
How can people use the results?
Researchers can consider this study’s limitations when designing future research.
Professional Abstract
Objective
To compare the effectiveness of two communication strategies on improving satisfaction with patient-physician communication and pain interference and reducing high-risk medication use among patients with chronic pain and opioid medication prescriptions
Study Design
| Design Element | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 82 primary care physicians and 951 of their patients ages 18 and older with a prescription for an opioid medication for 30 days or more, 2 or more opioid prescriptions in a 3 month period, or a total amount of 700 or more morphine milligram equivalents of opioids in any prescription |
| Interventions/ Comparators |
|
| Outcomes |
Primary: satisfaction with patient-physician communication as measured by CG-CAHPS, pain interference Secondary: physical function, depression, rates of high-dose opioid prescriptions defined as at or over 90 morphine milligram equivalents per day, coprescribing opioids and benzodiazepines |
| Timeframe | Up to 1-year follow-up for primary outcomes |
This pragmatic, cluster randomized trial compared the effectiveness of two strategies to improve patient-provider communication for chronic pain management:
- Clinician Decision Support (CDS). Physicians received an alert in the electronic health record when they prescribed a high-dose opioid or opioids and benzodiazepines together. Alerts included links to prescribing guidelines and suggestions for providing education to patients.
- Patient Education and Activation Tools (PEAT). Patients received education materials by email two days before their scheduled visits. Education materials helped patients prepare for visits and encouraged discussion with their physician about their treatment preferences and goals.
Researchers randomly assigned physicians to one of the two strategies; patients received the intervention assigned to the physician.
The study included 951 patients who received an opioid prescription from one of 82 primary care physicians in the Cedars-Sinai Medical Network. Of these patients, 63% were White, 22% were Black, 6% were Asian, less than 1% were American Indian or Native Hawaiian, and 8% did not report a race or race was missing; 11% were Hispanic. The average age was 54, and 58% were female.
Patients received satisfaction surveys by mail one month after each physician visit. Researchers also sent patients monthly surveys via email that asked about pain interference and physical function. Researchers compared responses pre- and post-intervention implementation. To assess satisfaction outcomes, researchers examined the change before and after the intervention in the percentage of top-box responses, which is the percentage of respondents who gave the highest possible satisfaction score. Researchers collected data about depression and prescriptions from patients’ electronic health records.
Patients with chronic pain, patient advocacy groups, and doctors helped design and carry out the study.
Results
After one year, the two strategies did not differ significantly in patients’ pain interference, physical function, depression symptoms, or rates of prescriptions for both opioids and benzodiazepines. The PEAT strategy was nearly three times more likely to have a greater increase in the top-box response for patient-physician communication than the CDS strategy (odds ratio [OR]=2.65; 95% confidence interval [CI]: 1.03, 6.8). However, patients who received PEAT were nearly two times more likely to have a high-dose opioid prescription in the post-intervention period (OR=1.90; 95% CI: 1.3, 2.78).
Limitations
At the start of the study, patients in the two strategies differed significantly on satisfaction and opioid prescription doses. Less than 40% of patients responded to satisfaction surveys, and less than 20% responded to pain and physical function surveys. Of the 82 physicians, only 52 had complete pre- and post-intervention satisfaction data. These limitations make it difficult to draw conclusions about the comparison.
Conclusions and Relevance
Although use of PEAT and CDS was associated with some improved outcomes, study limitations make results equivocal.
Future Research Needs
Future research could use other methods to evaluate these patient-physician communication strategies about use of opioid pain medications.
Final Research Report
View this project's final research report.
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. Those comments and responses included the following:
- Reviewers questioned the study conclusions indicating that one intervention was found to be better than the other on the main outcome. Reviewers explained that they believed this conclusion to be overstated because the two groups were not comparable at baseline and there was significant missing data. The researchers added text in multiple places acknowledging how group differences and missing data might have biased the study results and reminding the reader to consider the study results within these limitations.
- Some reviewers were skeptical about the actual engagement and consideration of patient stakeholders in establishing the research questions and the overall focus of the report because they perceived that less weight was given to patient-reported outcomes and the patient experience than to other outcomes. The study patient partners wrote a lengthy response to the reviewers describing their active involvement and explaining why some of the online materials for patients had not been updated once study recruitment ended. They also expanded the description of patient and stakeholder engagement in the report.
- Some reviewers hypothesized the missing data could be attributed to patients feeling stigmatized because they were being asked questions related to their opioid use, and that better patient engagement could have addressed this response from patients. The study patient partners acknowledged that some patients may have felt uncomfortable answering questions about their opioid use but that this was not because of poor patient engagement. The researchers pointed out that the goal of this study was to find the best ways to communicate with patients about the possibility of reducing their reliance on opioids.
Conflict of Interest Disclosures
Project Information
Patient / Caregiver Partners
Penney Cowan, Founder & CEO, American Chronic Pain Association Tom Norris, Chronic Pain Patient & Chronic Pain Patient Advocate
Other Stakeholder Partners
Consumer Reports Health ABIM Foundation