Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study (VOICE)

Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Medication management; Other: Non-pharmacological pain management; Drug: Buprenorphine-Naloxone

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 Type: Interventional
• Enrollment (Actual): 820
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telecare collaborative management (TCM); 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.	Other: Medication management; Individualized management of medications for pain
Active Comparator: Integrated pain team (IPT); Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.	Other: Medication management; Individualized management of medications for pain; Other: Non-pharmacological pain management; Individualized management of non-medication pain treatment approaches
Active Comparator: Standard taper options; The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.	Other: Medication management; Individualized management of medications for pain
Active Comparator: Expanded taper options; 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.	Other: Medication management; Individualized management of medications for pain; Drug: Buprenorphine-Naloxone; Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR-12 Physical Component Score	Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)	12 months
Symptom Checklist	Medication-related adverse symptoms count (0-19; higher is worse)	12 months
PODS Problems	Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)	12 months
PHQ-8	Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)	12 months
GAD-7	General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)	12 months
PROMIS Sleep Disturbance	Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.	12 months
PROMIS Fatigue	Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.	12 months
Headache Impact Test	Headache Impact Test score (range 36-78; higher is worse)	12 months
VR-12 Mental Component Score	Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)	12 months
PODS Concerns	Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)	12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Patient-Centered Outcomes Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: January 1, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimated): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Back pain; Opioid analgesics; Health care delivery; Opioid partial agonists; Veterans health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: OPD-1511-33052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No