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 people who use opioids for a long time are at risk for health problems like addiction, overdose, and injuries.
In this study, the research team compared two types of chronic pain care for veterans in reducing pain and daily dose of opioids:
- Integrated pain team, or IPT. In this group, veterans received care from a team that included a doctor, a mental health therapist, and a rehabilitation therapist or pharmacist. They had at least three visits with the doctor. They also had eight phone calls with the mental health therapist. The calls focused on providing support and resources to help veterans follow their pain care plan.
- Telecare collaborative management, or TCM. In this group, veterans received care led by a pharmacist. They had at least six visits with the pharmacist, who monitored symptoms and adjusted pain medicines.
For veterans receiving high-dose opioids, the research team also compared offering versus not offering the option to switch to buprenorphine, a medicine that can treat pain or opioid use disorder.
What were the results?
After one year, veterans who received the two types of care didn’t differ in overall pain or daily dose of opioids. Veterans receiving IPT or TCM had:
- Less pain overall
- Lower daily doses of opioids
The two types of care didn’t differ in how much these outcomes improved.
For veterans receiving high-dose opioids, those who were or were not offered buprenorphine didn’t differ in overall pain or daily dose of opioids.
Who was in the study?
The study included 820 veterans with chronic pain who were prescribed daily opioids for at least three months. Of these veterans, 74 percent were White, 16 percent were Black, 5 percent were Hispanic, 5 percent were more than one race or ethnicity, and 3 percent were another ethnicity. The average age was 62, and 86 percent were men. All received care at one of 10 Veterans Affairs, or VA, clinics. After one year, 712 veterans completed the study.
What did the research team do?
The research team assigned veterans by chance to receive IPT or TCM. They also assigned veterans on high-dose opioids to be offered or not offered the option to switch to buprenorphine.
At the start of the study and every three months for a year, veterans completed surveys about their pain. The research team looked at pharmacy records for the daily dose of opioids.
Veterans, doctors, and VA health system leaders helped throughout the study.
What were the limits of the study?
Most patients in the study were men, and all received care at VA hospitals. Results may differ for patients of other backgrounds or for those receiving care at other types of hospitals.
Future research could look at ways to reduce pain and opioid doses in non-VA populations.
How can people use the results?
Other VA clinics could use these results when considering ways to treat veterans with chronic pain.
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 noncancer 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 (1) two pain management programs for veterans prescribed long-term opioid medications and (2) two medication management options for veterans prescribed high-dose opioids, in reducing pain and opioid daily dose
Study Design
Design Element | Description |
---|---|
Study Design | Randomized controlled trial |
Population | Cohort for objective 1: 820 veterans who had pain of at least moderate severity for at least 6 months, were on long-term opioid treatment (≥20 mg/day for at least 3 months), and were receiving care at a VA primary care clinic Cohort for objective 2: a subgroup of 207 veterans who had pain of at least moderate severity for at least 6 months, were on long-term, high-dose opioid treatment (≥70 mg/day for at least 3 months), and were receiving care at a VA primary care clinic |
Interventions/ Comparators | Objective 1:
Objective 2:
|
Outcomes | Primary: patient-reported pain and pain interference with function as measured by BPI total score Secondary: opioid daily dose |
Timeframe | 1-year follow-up for primary outcome |
This pragmatic randomized controlled trial compared the effectiveness of two approaches to reducing pain and opioid daily dose among veterans prescribed long-term opioids. The trial also compared whether being offered buprenorphine reduced pain or decreased opioid daily dose for a subgroup of participants who were prescribed high-dose opioids.
For objective 1, researchers randomly assigned veterans prescribed opioids and receiving care at Veterans Affairs (VA) primary care clinics to one of two groups:
- Integrated pain team (IPT). This group received care from an interdisciplinary team with a medical clinician, mental health clinician, and either a rehabilitation therapist or a clinical pharmacist. Veterans had at least three medical visits, which included medication management and nondrug pain therapies, and eight phone calls with a mental health clinician focused on helping them follow their pain care plans.
- Telecare collaborative management (TCM). This group received care led by a clinical pharmacist care manager. They had at least six visits with a pharmacist care manager who monitored symptoms, managed medications, and referred patients to other therapies.
For objective 2, researchers randomly assigned veterans who were prescribed high-dose opioids to have or not have the option of switching from their current opioid medication to buprenorphine.
The study included 820 veterans with chronic pain receiving care at one of 10 VA clinics across the United States. Of the participants, 74% were White, 16% were Black, 5% were Hispanic, 5% were more than one race or ethnicity, and 3% were another ethnicity. The average age was 62, and 86% were male.
At baseline and every three months for one year, researchers surveyed veterans using the Brief Pain Inventory (BPI) and reviewed pharmacy data for opioid daily dose.
Veterans with chronic pain, clinicians, and operations leaders provided input throughout the study.
Results
At one year, researchers analyzed data for 712 veterans. IPT and TCM did not differ significantly; both IPT and TCM groups had lower BPI pain scores and lower opioid daily dose:
- 16% of veterans receiving IPT and 15% of veterans receiving TCM achieved at least a 30% reduction in pain scores.
- 25% of veterans receiving IPT and 25% of veterans receiving TCM achieved a 50% reduction in opioid daily dose.
For veterans prescribed high-dose opioids, BPI total score and opioid daily dose did not differ significantly between the groups given or not given the option to switch to buprenorphine.
Limitations
Most study participants were male, and all received care at the VA. Findings may not be generalizable to other populations.
Conclusions and Relevance
In this study, IPT and TCM had similar effects in reducing pain and opioid daily dose. An offer to switch to buprenorphine did not reduce pain or opioid daily dose.
Future Research Needs
Future research could test approaches to interdisciplinary pain management in non-VA populations.
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 noncancer 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 October 2024.
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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 lauded the researchers for addressing the PCORI methodology standards well but noted that the interventions studied meet criteria for complex health interventions. The reviewers asked the researchers to address those methodology standards as well. The researchers agreed that their study involved complex health interventions but explained that since those methodology standards had not been available when the study started, they were not able to address each part of the standards fully. However, they did add text to the report providing more information about the goals of the interventions and intervention components in order to address these standards at least partially.
- The reviewers noted that the researchers reported 15 study-related hospitalizations and asked for more information about these hospitalizations and how they were related to the study. The researchers explained that they considered hospitalizations to be potentially study-related if the hospitalization was for chronic pain or opioid use in patients who were being managed by study clinicians.
- The reviewers asked the researchers to consider whether their change in the cutoff eligibility for moderate-dose opioid therapy might have biased study results. The researchers stated that they did not consider the change in dose eligibility criteria and thresholds likely to bias the study results because their data indicated no differences in intervention effects related to the new enrollment categories.