Clinical trial NCT03026790: Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
Official title: Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Opioid analgesics
Opioid partial agonists
Health care delivery
Back pain
Osteoarthritis
Veterans health
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-01-20
Enrollment: 820
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

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

Primary outcomes:
measure: Pain Response
timeFrame: 12 months
Secondary outcomes:
measure: 50% Reduction in Opioid Daily Dose
timeFrame: 12 months
measure: Composite Response
timeFrame: 12 months
measure: Brief Pain Inventory (BPI) Total Score
timeFrame: 12 months
Other outcomes:
measure: VR-12 Physical Component Score
timeFrame: 12 months
measure: Symptom Checklist
timeFrame: 12 months
measure: PODS Problems
timeFrame: 12 months
measure: PHQ-8
timeFrame: 12 months
measure: GAD-7
timeFrame: 12 months
measure: PROMIS Sleep Disturbance
timeFrame: 12 months
measure: PROMIS Fatigue
timeFrame: 12 months
measure: Headache Impact Test
timeFrame: 12 months
measure: VR-12 Mental Component Score
timeFrame: 12 months
measure: PODS Concerns
timeFrame: 12 months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
References:
citation: Krebs EE, Becker WC, Nelson D, DeRonne BM, Nugent S, Jensen AC, Amundson EC, Manuel JK, Borsari B, Kats AM, Seal KH. Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study. Contemp Clin Trials. 2023 Jan;124:107001. doi: 10.1016/j.cct.2022.107001. Epub 2022 Nov 13.