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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

Tracking Information
First Submitted Date  ICMJE January 1, 2017
First Posted Date  ICMJE January 20, 2017
Last Update Posted Date May 5, 2022
Actual Study Start Date  ICMJE October 19, 2017
Actual Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Change in opioid daily dose from 0 to 12 months [ Time Frame: 12 months ]
    Number with 50% reduction in opioid daily dose
  • Number with both 30% improvement in BPI and 50% reduction in opioid dose [ Time Frame: 12 months ]
    Composite outcome
  • Continuous Brief Pain Inventory (BPI) total score [ Time Frame: 12 months ]
    Comparison of group means
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Change in opioid daily dose from 0 to 12 months [ Time Frame: 12 months ]
    Number with 50% reduction in opioid daily dose
  • Number with both 30% improvement in BPI and 50% reduction in opioid dose [ Time Frame: 12 months ]
    Composite outcome
Current Other Pre-specified Outcome Measures
 (submitted: October 13, 2020)
  • Veterans RAND 12-item health survey (VR-12) [ Time Frame: 3, 6, 9, and 12 months ]
    Mental and Physical Component Scores
  • Symptom checklist [ Time Frame: 6 and 12 months ]
    medication-related adverse symptoms
  • Prescribed Opioids Difficulty Scale (PODS) [ Time Frame: 6 and 12 months ]
    opioid related problems and concerns
  • Patient Health Questionnaire-8 [ Time Frame: 6 and 12 months ]
    depression symptoms
  • General Anxiety Disorders questionnaire (GAD-7) [ Time Frame: 6 and 12 months ]
    anxiety symptoms
  • PTSD checklist (PCL), version C, DSM-V update [ Time Frame: 6 and 12 months ]
    post-trauma symptoms
  • PROMIS Sleep Disturbance [ Time Frame: 6 and 12 months ]
    sleep disturbance
  • PROMIS Sleep-Related Impairment [ Time Frame: 6 and 12 months ]
    sleep-related impairment
  • Headache Impact Test [ Time Frame: 6 and 12 months ]
    headache severity
Original Other Pre-specified Outcome Measures
 (submitted: January 17, 2017)
  • Veterans RAND 12-item health survey (VR-12) [ Time Frame: 3, 6, 9, and 12 months ]
    Mental and Physical Component Scores
  • Symptom checklist [ Time Frame: 6 and 12 months ]
    medication-related adverse symptoms
  • Prescribed Opioids Difficulty Scale (PODS) [ Time Frame: 6 and 12 months ]
    opioid related problems and concerns
  • Patient Health Questionnaire-8 [ Time Frame: 6 and 12 months ]
    depression symptoms
  • General Anxiety Disorders questionnaire (GAD-7) [ Time Frame: 6 and 12 months ]
    anxiety symptoms
  • PTSD checklist (PCL), version C, DSM-V update [ Time Frame: 6 and 12 months ]
    post-trauma symptoms
  • Multidimensional Fatigue Inventory [ Time Frame: 6 and 12 months ]
    fatigue
  • PROMIS Sleep Disturbance [ Time Frame: 6 and 12 months ]
  • PROMIS Sleep-Related Impairment [ Time Frame: 6 and 12 months ]
  • Widespread Pain Index [ Time Frame: 6 and 12 months ]
  • Headache Impact Test [ Time Frame: 6 and 12 months ]
 
Descriptive Information
Brief Title  ICMJE Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
Official Title  ICMJE Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Other: Medication management
    Individualized management of medications for pain
  • Other: Non-pharmacological pain management
    Individualized management of non-medication pain treatment approaches
  • Drug: Buprenorphine-Naloxone
    Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
Study Arms  ICMJE
  • 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.
    Intervention: Other: Medication management
  • Active Comparator: Integrated pain team (IPT)
    Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
    Interventions:
    • Other: Medication management
    • Other: Non-pharmacological pain management
  • Active Comparator: Standard taper options
    The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.
    Intervention: Other: Medication management
  • 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.
    Interventions:
    • Other: Medication management
    • Drug: Buprenorphine-Naloxone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 14, 2021)
820
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
1400
Estimated Study Completion Date  ICMJE October 30, 2022
Actual Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03026790
Other Study ID Numbers  ICMJE OPD-1511-33052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP