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.

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

Brennan Spiegel, MD
Cedars-Sinai Medical Center
Integrating the Patient Voice into a Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain

Key Dates

December 2016
February 2022

Study Registration Information


Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 14, 2024