Yale University
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a pilot randomized clinical trial format. Findings from this research may improve pain management and decrease risk of opioid-related adverse events among patients with chronic pain.
Opioid Dependence
Chronic Pain
Enhanced Opioid Stewardship Program
Not Applicable
The primary objective of this study is to determine whether an enhanced opioid stewardship program, tailored to the needs of patients with chronic pain, is feasible to implement in a hospital setting. One secondary objective is to determine whether an enhanced opioid stewardship program increases use of guideline-based opioid care. The other secondary objective of this study is to determine whether an enhanced opioid stewardship program reduces pain frequency, intensity, and interference and decreases the risk for opioid-related adverse events among adult patients with chronic pain hospitalized on medical units at Yale-New Haven Hospital, York Street and Saint Raphael campuses. This is a pilot randomized controlled trial of 100 adult participants. It is prospective and focus primarily on feasibility. There will be up to 3 study visits with each participant, which will take place during hospitalization or in the first week after hospital discharge.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 52 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Other |
| Official Title : | Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain |
| Actual Study Start Date : | July 7, 2022 |
| Estimated Primary Completion Date : | November 1, 2022 |
| Estimated Study Completion Date : | November 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Enhanced Opioid Stewardship Program Enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team |
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No Intervention: Standard of care |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Yale New Haven Hospital, 20 York Street
New Haven, Connecticut, United States, 06510
Not yet recruiting
Yale New Haven Hospital, 1450 Chapel Street
New Haven, Connecticut, United States, 06511