Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support (OPTI)
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|ClinicalTrials.gov Identifier: NCT02230722|
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Motivational Interviewing Behavioral: Attention Control||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 12, 2017|
|Actual Study Completion Date :||June 12, 2017|
Active Comparator: Attention Control
The neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions.
Behavioral: Attention Control
Experimental: Collaborative Care
Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain.
Behavioral: Motivational Interviewing
- To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention. [ Time Frame: 20 weeks post baseline ]
- PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients
- The CM will conduct MI communication with high fidelity.
- Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care.
- To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients. [ Time Frame: 20 weeks post baseline ]
Compared to ATHENA-OT plus Attention Control:
H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact.
H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies.
H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability.
H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans.
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): NCT02230722
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Karen Seal, MD, MPH||SFVAMC|