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

Location

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 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

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

Actual Primary Completion Date :

Mar 17, 2022

Anticipated Study Completion Date :

Oct 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

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

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

Other Outcome Measures

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

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