Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Phase 2

Completed

• Conditions: Chronic Pain
• Interventions: Other: Medication management; Other: Non-pharmacological pain management; Drug: Buprenorphine-Naloxone

• Registration Number: NCT03026790
• Lead Sponsor: University of Minnesota

Brief Summary

Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.

Detailed Description

Study aims: This study will test which of two pain treatment strategies is better for managing pain and helping patients improve safety of opioid medication. For patients on high opioid doses who want to reduce, this study will also test whether offering an extra option for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine patients' and clinicians' experiences with the interventions.

Study description: The study will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by VA healthcare facilities across the country. Patients who wish to enter the study will be assigned by chance to telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a pharmacist and supervising physician working together to find the best medication options for each individual patient. In IPT, a team of clinicians focuses on non-medication pain management options, in addition to pain medication.

All participants will be asked to stay in the study for 12 months. Patients for whom it would be unsafe to participate will not be invited to join. With either treatment strategy, TCM or IPT, participants will have individualized pain care tailored to their needs and preferences. Participants on high opioid medication doses who want to reduce their opioid medication dose will be assigned by chance to get either a regular step-wise taper or a choice between a regular taper or switching to a different medication (buprenorphine-naloxone).

At the end of the study, the two treatment strategies will be compared to see which worked better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes important to patients will also be tracked. These include quality of life, sleep, fatigue, depression, anxiety, and side effects.

Study Timeline

• Study First Submitted: 2017-01-01
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-10-19
• Primary Completion: 2022-03-17
• Study Completion: 2022-10-30
• Results First Submitted: 2023-03-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-07
• Last Update Submitted: 2023-05-07
• Results First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
• Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

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Exclusion Criteria

• Dementia diagnosis
• Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
• Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
• Documentation of suspected controlled substance diversion
• Inability to communicate by telephone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Telecare collaborative management (TCM)	Medication management	Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.
Standard taper options	Medication management	The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.
Expanded taper options	Medication management	The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.
Integrated pain team (IPT)	Medication management	Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Integrated pain team (IPT)	Non-pharmacological pain management	Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Expanded taper options	Buprenorphine-Naloxone	The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.

Primary Outcome Measures

Name	Time	Method
Pain Response	12 months	Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

Secondary Outcome Measures

Name	Time	Method
50% Reduction in Opioid Daily Dose	12 months	Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline
Composite Response	12 months	Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.
Brief Pain Inventory (BPI) Total Score	12 months	Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)

Trial Locations

Locations (1)

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States