Results Summary
What was the research about?
Acute pain, like severe back pain, headache, or joint and muscle pain, is a common health problem that can limit function and well-being. Medicines called opioids can help ease acute pain. But long-term opioid use can lead to addiction or overdose.
Clinical practice guidelines identify prescribing practices that clinicians, like doctors or nurses, should avoid when using opioids to treat acute pain. Unsafe practices may include prescribing high levels of opioids or long-acting opioids at a patient’s first visit.
In this study, the research team compared four ways to help clinicians treat acute pain safely. They looked at the effect on patients’ pain and on reducing unsafe opioid prescribing. The four ways were:
- Guideline alone. The electronic health record, or EHR, displayed the guideline when the clinician wanted to prescribe an opioid.
- Guideline plus reason for prescribing. The EHR displayed the guideline. If the clinician wanted to prescribe the opioid, they had to enter a reason into the EHR.
- Guideline plus comparison report. The EHR displayed the guideline. Also, the clinician received a monthly email that compared how often they prescribed opioids for acute pain and how well they followed the guideline versus their peers.
- Guideline plus reason and comparison report. The EHR displayed the guideline. The clinician also entered a reason for prescribing opioids and received the monthly email.
What were the results?
Compared with clinicians who received the guideline alone, clinicians who entered a reason for prescribing and received a comparison report had lower rates of prescribing opioids.
The four ways didn’t differ in:
- The percentage of patients whose doctors had unsafe opioid prescribing practices
- Patients' pain levels
- The percentage of patients who continued using opioids long term
Who was in the study?
The study included 22,616 adults with acute pain. All received care from one of 48 clinics in three health systems in Pennsylvania and Utah. Patients had not used opioids for at least one year. Of patients, 84 percent were White, 5 percent were Black, 3 percent were Asian, and 8 percent were another race or unknown race; 8 percent were Hispanic. The average age was 49, and 57 percent were men.
What did the research team do?
The research team assigned clinics by chance to one of the four ways. The team looked at EHRs to see if clinicians prescribed opioids to patients at their first visit. The team also assessed unsafe prescribing practices after 3, 6, and 12 months. Patients completed surveys about their pain levels 1, 6, and 12 months after their first visit.
Patients with acute pain, clinicians, and health insurers helped design the study.
What were the limits of the study?
Most patients in the study were White. Results may differ for patients of other racial and ethnic backgrounds.
Future research could test other ways to help clinicians reduce unsafe opioid prescribing.
How can people use the results?
Clinics can use the results when considering how to help clinicians prescribe opioids safely.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
PCORI identified unsafe opioid prescribing as an important research topic. Patients, clinicians, and others wanted to learn: How can primary care providers work with patients with non-cancer pain to plan safe treatment and provide adequate pain management? To help answer this question, PCORI launched an initiative in 2016 on Strategies to Prevent Unsafe Opioid Prescribing in Primary Care among Patients with Acute or Chronic Noncancer Pain. The initiative funded this research project and others.
Professional Abstract
Objective
To compare the effectiveness of behavioral interventions versus usual care in increasing safe opioid prescribing habits among primary care providers and in managing pain among patients with acute non-cancer pain
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 22,616 adult patients diagnosed with acute non-cancer pain, such as acute musculoskeletal pain or headaches, who had not used opioids before |
| Interventions/ Comparators |
|
| Outcomes |
Primary: percentage of patients who were prescribed opioids at first clinic visit Secondary: percentage of patients exposed to unsafe prescribing practices, patient-reported level of pain, percentage of patients who transitioned to long-term opioid therapy |
| Timeframe | Same-visit follow-up for primary outcomes |
This randomized controlled trial compared the effectiveness of provider-focused behavioral interventions versus usual care in increasing safe opioid prescribing practices and improving pain levels among patients with acute non-cancer pain.
The study included 22,616 patients diagnosed with acute non-cancer pain who received care at one of 48 clinics in three health systems in Pennsylvania and Utah. Patients had not used opioids for at least one year. Of patients, 84% were White, 5% were Black, 3% were Asian, and 8% were another race or unknown race; 8% were Hispanic. The average age was 49, and 57% were male.
Researchers randomly assigned clinics to one of four groups. Patients received the intervention assigned to their clinic. When prescribing an opioid, providers in the four groups received:
- Clinical guideline alone (usual care). The electronic health record (EHR) displayed the guideline when the provider wanted to prescribe an opioid. The provider then decided whether to prescribe the opioid.
- Clinical guideline plus opioid justification. The EHR displayed the guideline, and providers were required to enter the reason they decided to prescribe the opioid.
- Clinical guideline plus provider comparison. The EHR displayed the guideline, and providers received individualized monthly emails on how often they prescribed opioids for acute pain and adhered to the clinical guidelines compared with other providers in the study.
- Clinical guideline plus opioid justification and provider comparison. The EHR displayed the guideline, providers were required to enter a reason for prescribing opioids, and they received individualized monthly emails with details on their prescribing habits.
At 3, 6, and 12 months, researchers reviewed EHR data. They examined opioid prescriptions at patients’ first visits and how many patients received care from providers with unsafe prescribing practices, such as those who prescribed high-dose or long-acting opioids at first visit. Patients completed surveys about their pain levels 1, 6, and 12 months after their first visit.
Patients with a history of acute pain, providers, and health insurers helped design the study.
Results
Compared with the clinical guideline only group, the group with the clinical guideline plus opioid justification and provider comparison had lower rates of prescribing opioids to patients (adjusted odds ratio: 0.44; 95% confidence interval: 0.22, 0.87).
The groups did not differ significantly in the percentage of patients exposed to unsafe opioid prescribing practices, patients’ pain levels, or the percentage of patients who transitioned to long-term opioid therapy.
Limitations
Most patients in the study were White. Results may differ for patients of other racial and ethnic backgrounds.
Conclusions and Relevance
In this study, primary care providers who both entered a justification for prescribing an opioid and also received a provider comparison had lower rates of opioid prescription than usual care.
Future Research Needs
Future research could test other ways to help clinicians prevent unsafe opioid prescribing practices.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
PCORI identified unsafe opioid prescribing as an important research topic. Patients, clinicians, and others wanted to learn: How can primary care providers work with patients with non-cancer pain to plan safe treatment and provide adequate pain management? To help answer this question, PCORI launched an initiative in 2016 on Strategies to Prevent Unsafe Opioid Prescribing in Primary Care among Patients with Acute or Chronic Noncancer Pain. The initiative funded this research project and others.
Final Research Report
This project's final research report is expected to be available by June 2023.
Journal Citations
Results of This Project
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 asked the researchers to comment on the low rates of opioid prescribing for non-cancer pain in primary care, noting that the low rates might change initial assumptions that higher prescribing rates are related to lower-quality care. The researchers said that in qualitative interviews with providers participating in the study, the providers felt that they had already adopted safer opioid prescribing practices and felt the intervention was unlikely to be beneficial. The researchers went on to state that they did not believe lower-than-expected prescribing rates changed the mechanism by which the behavioral interventions affected physician prescribing but acknowledged that providers were less likely to be exposed to the interventions because they were prescribing opioids less often and therefore not triggering the intervention.
- The reviewers commented that the study goals emphasized access to pain management without opioids as well as prevention of unsafe opioid prescribing, but there were no direct measures of providing access to or engagement in nonopioid pain management. The researchers explained that they did collect information on nonopioid pain management but ended up deemphasizing this information because nonopioid pain management was the main choice made by providers and therefore not as informative or interesting as prescribing-related quality of care. They added results to the report on nonopioid pain management in two new tables.
- Reviewers asked the researchers to justify their claim that the study sample of participants was diverse and representative of the population and also asked why the researchers included the University of Utah Health Care system when their stakeholders had focused on western Pennsylvania. The researchers agreed that their study sample was not racially or ethnically diverse due to the clientele at the participating clinical sites but considered the sample geographically diverse and geographically representative of the population. They also explained that the University of Utah participated because it was in the health system network involved in this research, Utah offered a more ethnically diverse population, and because Utah had some of the highest rates of opioid prescribing and opioid-related deaths.
- The reviewers requested that the researchers consider the potential impact of selection bias on the results from the qualitative study and for the Pain, Enjoyment, General Activity scale data analyses. The researchers agreed that collection of Pain, Enjoyment, General Activity scale data from only one of the sites introduced potential bias and added this information to their study limitations. They also explained how the qualitative interviews originally started with a random selection of providers, but poor recruitment led them to invite all of the providers to participate in interviews. The researchers described this more fully in the report.