Comprehensive Opioid Management in Patient Aligned Care Teams

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will enroll Veterans with chronic pain who have been receiving opioid medications (like methadone, percocet, oxycontin) on a regular basis for at least 3 months to treat their pain. The purpose of this study is to understand if two automated interventions that are delivered by phone can improve the safe and effective use of opioid medications and the physical functioning of Veterans with chronic pain who take opioid medications. One intervention, opioid monitoring, will include monthly automated calls to the enrolled Veteran to ask questions about their use of the opioid medications, pain relief, side effects, effect of pain on physical activity and mood and satisfaction with pain care. The other intervention, skills training, includes learning pain management skills using automated calls and a self-help book with weekly feedback calls from a nurse. Veterans who are enrolled in this study will be randomly assigned (by chance, like a flip of a coin) to receive either opioid monitoring only, self-management only, self-management plus opioid monitoring or a weekly automated phone call with wellness tips. Everyone enrolled in the study will complete questionnaires about their pain and other pain-related information at the beginning of the trial, after the interventions are completed 12 weeks later, and 3 and 6 months after treatment ends.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings

NCT03367234

Opioid-use Disorder Substance Use Disorders

WITHDRAWN NA

Virtual Pain Care Management (COVID-19)

NCT04539821

Chronic Pain

COMPLETED NA

An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment

NCT05051644

Opioid Use Disorder Chronic Pain

ACTIVE_NOT_RECRUITING PHASE1

Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment

NCT04178551

Opioid Medication Assisted Treatment

COMPLETED NA

Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

NCT02230722

Chronic Pain

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objectives of the study are to: 1) test the effectiveness of an automated intervention system called COMPACT for improving pain-relevant outcomes including physical functioning and pain intensity; 2) determine whether opioid monitoring promotes guideline concordant care; and 3) examine key components of the intervention process to inform future implementation.

This study is a randomized, controlled, multi-site, factorial design trial of a technology supported treatment program called COMPACT relative to enhanced usual care (EUC) in the PACT setting. Participants will include 380 Veterans receiving chronic opioid therapy (COT) and reporting chronic musculoskeletal pain of at least moderate severity. Outcomes of interest include pain-related physical functioning, pain intensity, presence of guideline concordant care practices, and provider satisfaction. Enrolled participants will be randomized to receive COMPACT treatment or EUC. At baseline, 12 weeks (post-treatment), 24 weeks (follow-up) and 36 weeks (follow-up) all participants will undergo an opioid risk evaluation and assessment of all outcome variables. Participants randomized to COMPACT treatment will received interactive voice response (IVR)-based pain self management training and monthly opioid risk monitoring. Throughout treatment COMPACT participants will undergo automated monthly opioid risk monitoring and collection of patient reported opioid use, pain intensity, physical functioning, emotional functioning and quality of life data. Monthly opioid risk monitoring information will be made available to PACT clinicians via automatic entry into CPRS prior to a scheduled opioid renewal appointment. Participants in the EUC condition will undergo assessment of outcome variables and opioid risk assessment at 12-, 24- and 36-weeks post baseline only; they will not receive treatment or opioid monitoring.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IVR self management

cognitive behavioral based self management training for chronic pain delivered by interactive voice response (IVR)

Group Type EXPERIMENTAL

IVR self-management

Intervention Type BEHAVIORAL

A course of self-management training that includes 12 education and self-management skill modules presented over 12 consecutive weeks. Participants will be asked to practice each skill daily and report via IVR on their completion of the daily skill practice. They will receive a 10 minute call each week from a nurse care manager to discuss their weekly progress.

Opioid monitoring

monthly interactive voice response (IVR) monitoring of prescription opioid use with feedback to the prescribing physician

Group Type EXPERIMENTAL

Opioid monitoring

Intervention Type BEHAVIORAL

Monthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.

IVR self management plus opioid monitoring

Cognitive behavioral based self management training for chronic pain delivered by IVR plus monthly IVR monitoring of prescription opioid use with feedback to the prescribing physician

Group Type EXPERIMENTAL

IVR self-management

Intervention Type BEHAVIORAL

A course of self-management training that includes 12 education and self-management skill modules presented over 12 consecutive weeks. Participants will be asked to practice each skill daily and report via IVR on their completion of the daily skill practice. They will receive a 10 minute call each week from a nurse care manager to discuss their weekly progress.

Opioid monitoring

Intervention Type BEHAVIORAL

Monthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.

Enhanced usual care

Weekly automated wellness tips via IVR

Group Type OTHER

Enhanced usual care

Intervention Type OTHER

Weekly automated wellness tip and usual clinical care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IVR self-management

A course of self-management training that includes 12 education and self-management skill modules presented over 12 consecutive weeks. Participants will be asked to practice each skill daily and report via IVR on their completion of the daily skill practice. They will receive a 10 minute call each week from a nurse care manager to discuss their weekly progress.

Intervention Type BEHAVIORAL

Opioid monitoring

Monthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.

Intervention Type BEHAVIORAL

Enhanced usual care

Weekly automated wellness tip and usual clinical care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* presence of at least moderate musculoskeletal diagnosis pain (i.e., pain scores of 4 as measured by the Numeric Rating Scale) for a period of 3 months. Musculoskeletal diagnosis is a cluster of disorders including:

* low back and spine conditions
* osteoarthritis
* nerve compression
* other inflammatory and degenerative disorders
* receipt of chronic opioid therapy \[90 continuous days out of any 104 day period in the prior 12 month\]
* ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at one block
* availability of a land line or cellular telephone

Exclusion Criteria

* active psychosis or suicidality that could impair participation, identified using validated measures in the baseline screener
* life threatening or acute medical condition that could impair participation
* dementia defined by a score of 20 or greater on the St. Louis University Mental Status in the baseline screener
* any sensory deficits that would impair participation (e.g., hearing loss to a degree that telephone usage is not possible)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No