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Chronic Pain | Comprehensive Opioid Management in Patient Aligned Care Teams

Chronic Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:IVR self-managementA 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 monitoringMonthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.

Other:Enhanced usual careWeekly automated wellness tip and usual clinical care

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

IVR self management plus opioid monitoringCognitive 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 careWeekly automated wellness tips via IVR

Study Status

Withdrawn

Start Date: April 1, 2017

Completed Date: April 1, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Brief Pain Inventory

Secondary Outcome: Concordance with opioid treatment practice guidelines

Study sponsors, principal investigator, and references

Principal Investigator: Alicia A. Heapy, PhD

Lead Sponsor: VA Office of Research and Development

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01737073

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