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

• ClinicalTrials.gov Identifier: NCT03026790
• Recruitment Status: Active, not recruiting
• First Posted: January 20, 2017
• Last Update Posted: May 5, 2022
• Sponsor: University of Minnesota
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Other: Medication management; Other: Non-pharmacological pain management; Drug: Buprenorphine-Naloxone	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 820 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
• Actual Study Start Date: October 19, 2017
• Actual Primary Completion Date: March 17, 2022
• Estimated Study Completion Date: October 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Brief Pain Inventory (BPI) total score from 0 to 12 months [ Time Frame: 12 months ]
   Number with 30% improvement in BPI total score

Secondary Outcome Measures :

1. Change in opioid daily dose from 0 to 12 months [ Time Frame: 12 months ]
   Number with 50% reduction in opioid daily dose
2. Number with both 30% improvement in BPI and 50% reduction in opioid dose [ Time Frame: 12 months ]
   Composite outcome
3. Continuous Brief Pain Inventory (BPI) total score [ Time Frame: 12 months ]
   Comparison of group means

Other Outcome Measures:

1. Veterans RAND 12-item health survey (VR-12) [ Time Frame: 3, 6, 9, and 12 months ]
   Mental and Physical Component Scores
2. Symptom checklist [ Time Frame: 6 and 12 months ]
   medication-related adverse symptoms
3. Prescribed Opioids Difficulty Scale (PODS) [ Time Frame: 6 and 12 months ]
   opioid related problems and concerns
4. Patient Health Questionnaire-8 [ Time Frame: 6 and 12 months ]
   depression symptoms
5. General Anxiety Disorders questionnaire (GAD-7) [ Time Frame: 6 and 12 months ]
   anxiety symptoms
6. PTSD checklist (PCL), version C, DSM-V update [ Time Frame: 6 and 12 months ]
   post-trauma symptoms
7. PROMIS Sleep Disturbance [ Time Frame: 6 and 12 months ]
   sleep disturbance
8. PROMIS Sleep-Related Impairment [ Time Frame: 6 and 12 months ]
   sleep-related impairment
9. Headache Impact Test [ Time Frame: 6 and 12 months ]
   headache severity

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Minnesota

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

University of Minnesota

Patient-Centered Outcomes Research Institute

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03026790
• Other Study ID Numbers: OPD-1511-33052
• First Posted: January 20, 2017
• Last Update Posted: May 5, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

• 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

Keywords provided by University of Minnesota:

Opioid analgesics; Opioid partial agonists; Health care delivery; Back pain; Osteoarthritis; Veterans health

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists