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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026790
Recruitment Status : Active, not recruiting
First Posted : January 20, 2017
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
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.

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.

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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


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026790


Locations
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United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
University of Minnesota
Patient-Centered Outcomes Research Institute
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03026790    
Other Study ID Numbers: OPD-1511-33052
First Posted: January 20, 2017    Key Record Dates
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.

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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:
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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