VOICE: Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03026790
Collaborator
Patient-Centered Outcomes Research Institute (Other)
820
Enrollment
1
Location
4
Arms
60.4
Anticipated Duration (Months)
13.6
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
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
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 :
Oct 19, 2017
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

ArmIntervention/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 [12 months]

    Number with 30% improvement in BPI total score

Secondary Outcome Measures

  1. Change in opioid daily dose from 0 to 12 months [12 months]

    Number with 50% reduction in opioid daily dose

  2. Number with both 30% improvement in BPI and 50% reduction in opioid dose [12 months]

    Composite outcome

  3. Continuous Brief Pain Inventory (BPI) total score [12 months]

    Comparison of group means

Other Outcome Measures

  1. Veterans RAND 12-item health survey (VR-12) [3, 6, 9, and 12 months]

    Mental and Physical Component Scores

  2. Symptom checklist [6 and 12 months]

    medication-related adverse symptoms

  3. Prescribed Opioids Difficulty Scale (PODS) [6 and 12 months]

    opioid related problems and concerns

  4. Patient Health Questionnaire-8 [6 and 12 months]

    depression symptoms

  5. General Anxiety Disorders questionnaire (GAD-7) [6 and 12 months]

    anxiety symptoms

  6. PTSD checklist (PCL), version C, DSM-V update [6 and 12 months]

    post-trauma symptoms

  7. PROMIS Sleep Disturbance [6 and 12 months]

    sleep disturbance

  8. PROMIS Sleep-Related Impairment [6 and 12 months]

    sleep-related impairment

  9. Headache Impact Test [6 and 12 months]

    headache severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ≥

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

SiteCityStateCountryPostal Code
1Minneapolis VA Health Care SystemMinneapolisMinnesotaUnited States55417

Sponsors and Collaborators

  • University of Minnesota
  • Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT03026790
Other Study ID Numbers:
  • OPD-1511-33052
First Posted:
Jan 20, 2017
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021