Comprehensive Opioid Management in Patient Aligned Care Teams
| Status: | Withdrawn |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | April 1, 2017 |
| End Date: | April 1, 2017 |
Comprehensive Opioid Management in Patient Aligned Care Teams (COMPACT)
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.
(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.
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.
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.
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)
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