Comprehensive Opioid Management in Patient Aligned Care Teams

Withdrawn before enrolling · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT01737073

Run by

VA Office of Research and Development

People needed

0

Starts

2017-04-01

Expected to finish

2017-04-01

Last updated by the study team

2019-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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