We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Opioid Management in Patient Aligned Care Teams (COMPACT)

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: NCT01737073
Recruitment Status : Withdrawn (This study was unable to overcome IT and contracting barriers which prevented the study's data collection system from being implemented.)
First Posted : November 29, 2012
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: IVR self-management Behavioral: Opioid monitoring Other: Enhanced usual care Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Opioid Management in Patient Aligned Care Teams (COMPACT)
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: IVR self management
cognitive behavioral based self management training for chronic pain delivered by interactive voice response (IVR)
 Behavioral: 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.
Experimental: Opioid monitoring
monthly interactive voice response (IVR) monitoring of prescription opioid use with feedback to the prescribing physician
 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.
Experimental: 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
 Behavioral: 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.

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.
Enhanced usual care
Weekly automated wellness tips via IVR
 Other: Enhanced usual care
Weekly automated wellness tip and usual clinical care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Post-treatment (12 weeks post baseline) ]

Secondary Outcome Measures :
  1. Concordance with opioid treatment practice guidelines [ Time Frame: Post-treatment ]
    Evaluation of the effect of the OM intervention on providers' concordance with VA/DoD chronic opioid treatment practice guidelines will be a quality score (scale 0 - 8) that represents the number of practices out of eight key practices to which providers adhered at the 12 weeks follow up. The eight key practices considered are: use of UDS, contra-indicated co-prescription, non-medication treatments, no psychiatric at risk/SUD, acetaminophen over-prescription, risky sedative co-prescription, bowel regimen and serious adverse effects


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01737073


Locations
Layout table for location information
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Alicia A. Heapy, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01737073    
Obsolete Identifiers: NCT02508285
Other Study ID Numbers: CRE 12-006
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
chronic pain
opioid
cognitive behavior therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents