Results Summary
What was the research about?
Opioid use disorder, or OUD, is a pattern of using opioids, such as prescription medicines or heroin, that can lead to addiction or overdose. Many people with OUD start using opioids after a visit to the emergency room, or ER, for acute pain.
In this study, the research team compared three ways to tell patients with acute pain about the risks of OUD after receiving care at the ER:
- A fact sheet with information about the benefits and harms of treatment options.
- A decision aid and the fact sheet. The decision aid was on a tablet computer. It showed patients their risk of OUD on a color-coded thermometer. To assess their risk of OUD, patients answered questions about their and their family’s history of drug use and abuse.
- The decision aid plus the fact sheet and videos about patients’ and caregivers’ experiences with OUD. Patients chose from a menu of eight short videos with speakers of different races and ages.
What were the results?
After two weeks, patients who received the decision aid with and without videos didn’t differ in recalling their OUD risk.
Compared with patients who received the fact sheet alone, patients who received the decision aid plus videos had a lower preference for opioids at their initial ER visit. They were also more satisfied with their treatment and reported being more involved in decisions about pain treatment. The study didn’t find these differences between patients who received the decision aid without videos and patients who received the fact sheet alone.
Patients in the three groups didn’t differ in:
- Reported use of opioids after 14 days
- Agreement with their doctor’s choice of pain medicine
- Trust in their doctor
- Shared decision making
- The number of additional doctor visits
- Physical function
Who was in the study?
The study included 1,301 English-speaking adults receiving care for back or kidney stone pain at four hospitals across the United States. Of these, 43 percent were White, 38 percent were Black, and 19 percent identified as another race or mixed race; 11 percent were Hispanic or Latino. The average age was 40, and 53 percent were women.
What did the research team do?
The research team assigned patients by chance to one of the three groups. The team surveyed patients during their ER visit, online daily for the first week after the visit, and again two weeks and three months later.
Patients with experience with acute pain and opioid use gave input on the study.
What were the limits of the study?
Patients may have answered questions based on what they thought researchers wanted to hear. The study results may not reflect patients’ true awareness of the risks of opioid misuse.
Future research could look at whether using patient videos and decision aids at other times or in other places better helps patients learn about risks of OUD.
How can people use the results?
Hospitals can use these results when considering ways to help patients who are deciding about using opioids to treat acute pain.
Professional Abstract
Objective
To compare the effectiveness of three methods for communicating the risks of opioid prescription misuse to patients with acute pain in acute care facilities
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 1,301 English-speaking acute care patients ages 18–70 with acute back or kidney stone pain |
Interventions/ Comparators |
|
Outcomes |
Primary: patient recall of risk category, patient-reported use and preference for opioid medication Secondary: satisfaction with pain treatment, patient participation in decisions about pain treatment, alignment of participant preference with provider choice for analgesia, trust in provider, shared decision making, patient-reported additional medical visits, functional outcomes |
Timeframe | Up to 14-day follow-up for primary outcomes |
This randomized controlled trial compared the effectiveness of using a visual probabilistic risk tool (PRT), a patient narrative enhanced probabilistic risk tool (NE-PRT), and a general risk information (GRI) sheet to communicate the risks of opioid misuse, improve patient recall of their risk category, and determine patient preference for and use of opioids.
All patients in the study received a GRI sheet with information about the benefits and harms of treatment options for acute back or kidney stone pain. Researchers randomly assigned patients to one of three groups:
- PRT. Patients learned their individual risk of opioid dependency based on factors such as family or personal history of drug use and age on a color-coded thermometer from a tablet computer.
- NE-PRT. Patients received the PRT and watched videos of patients’ and caregivers’ experiences with opioid use disorder. Patients chose from a menu of short videos with storytellers of varying races and ages.
- GRI. Patients received the GRI sheet alone.
The study included 1,301 adults receiving care for acute back or kidney stone pain at emergency departments in six hospitals across the United States. Of these patients, 43% were White, 38% were Black, and 19% were another race or multi-racial; 11% were Hispanic or Latino. The average age was 40, and 53% were female.
Researchers surveyed patients during their visit and again online daily for the first week and at two weeks and three months after discharge.
Patients with experience managing pain with opioids gave input throughout the study.
Results
Fourteen days after discharge, the NE-PRT and PRT groups did not differ significantly in recalling their opioid risk category.
Compared with the GRI group, the PRT group did not differ significantly in their preference for opioids at the end of their initial visit, or in their satisfaction with pain treatment or participation in decisions about pain treatment at day one.
Compared with the GRI group, the NE-PRT group had a lower preference for opioids at the end of their initial visit, was more satisfied with their pain treatment, and perceived higher levels of participation in decisions about treatment options for pain at day one (all p<0.05).
The three groups did not differ significantly in other study outcomes.
Limitations
Patients may have answered PRT questions based on their sense of what the researchers wanted to hear. As a result, survey results may not accurately reflect changes in knowledge and awareness of opioid misuse risks.
Conclusions and Relevance
Patients in the NE-PRT group had a decreased preference for opioids compared with the GRI group. However, the study found no differences among groups for recall of risk of opioid misuse or for opioid use.
Future Research Needs
Future research could explore whether using patient narratives and visual risk information in different settings or at a different time points improves their effectiveness.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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:
- The reviewers expressed concern about the conclusions presented in the report, which they saw as overly positive and not well supported by the study results. The reviewers also stressed that the report should consider the clinical importance of the results, rather than only the statistical significance, in assessing the impact of the findings. The researchers revised the report to a more conservative interpretation of the results.
- The reviewers identified problems in the study design that could not be addressed now that the study was completed. In particular, the reviewers felt that the study used inadequate measures of opioid use. The researchers explained that during the study, the use of prescription opioid medications to treat patients presenting with pain in the emergency department declined as U.S. population became more aware of the growing opioid crisis. This, along with new state policies regarding opioid use reporting, created significant challenges in measuring opioid use and opioid-free days based on prescriptions and electronic medical records. The researchers acknowledged that their eventual opioid use measure, using patient-reported use, was weak, and revised the report to acknowledge this weakness as a study limitation.
- The reviewers also questioned the use of risk recall, or patient recall of personal risk related to opioid use, as the primary trial outcome when this variable is more a predictor of health than a health-related outcome itself. The researchers explained that risk recall was a predetermined outcome based on discussions with their patient collaborators, experts in risk communication, and study reviewers. They did acknowledge that the fact that risk recall could only be measured in two of the three groups was also a disadvantage, and that this added a limitation to the findings of the study.
- The reviewers noted that the interventions used in this study had not previously been validated and seemed at face value to vary a great deal in the quality of their stimuli (for instance, a general risk information sheet versus a color-coded thermometer displaying probable risk). The researchers responded that both visual risk communication tools used in this project had been studied in other settings but acknowledged that there were limitations to these interventions that had not previously been studied.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^This project was previously titled: The Comparative Effectiveness of Probabilistic versus Patient Narrative: Enhanced Risk Communication for Pain Management Following Acute Care
This project's final research report is expected to be available by June 2022. |