Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain

Yale University

Status: Completed

Conditions: Chronic Pain; Opioid Dependence

Treatments: Other: Enhanced Opioid Stewardship Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05370326

1RM1DA055310-01 (U.S. NIH Grant/Contract)

2000032638

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admitted at Yale New Haven Hospital (YSC and SRC) on medical units
• identified as having chronic pain and prescribed opioids
• have opioid dependence (evidenced by ongoing opioid prescription, meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for Opioid Use Disorder, or clinical history)

Exclusion criteria

• active cancer
• current pregnancy
• hospice care/comfort measures only
• admission to inpatient psychiatry
• completed or planned Addiction Medicine consult during hospitalization

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Enhanced Opioid Stewardship Program

Experimental group

Description:

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

Treatment:

Other: Enhanced Opioid Stewardship Program

Standard of care

No Intervention group