Study Stopped
This study was unable to overcome IT and contracting barriers which prevented the study's data collection system from being implemented.
Comprehensive Opioid Management in Patient Aligned Care Teams
COMPACT
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMarch 7, 2019
March 1, 2019
Same day
November 26, 2012
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Pain Inventory
Post-treatment (12 weeks post baseline)
Secondary Outcomes (1)
Concordance with opioid treatment practice guidelines
Post-treatment
Study Arms (4)
IVR self management
EXPERIMENTALcognitive behavioral based self management training for chronic pain delivered by interactive voice response (IVR)
Opioid monitoring
EXPERIMENTALmonthly interactive voice response (IVR) monitoring of prescription opioid use with feedback to the prescribing physician
IVR self management plus opioid monitoring
EXPERIMENTALCognitive 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
Enhanced usual care
OTHERWeekly automated wellness tips via IVR
Interventions
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.
Monthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alicia A. Heapy, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2012
First Posted
November 29, 2012
Study Start
April 1, 2017
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 7, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share