Clinical trial NCT05370326: Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
Official title: Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Chronic Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment
timeFrame: approximately 3 months
measure: Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment
timeFrame: approximately 3 months
measure: Days to Hospital Day of Enrollment
timeFrame: approximately 3 months
measure: Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention
timeFrame: approximately 3 months
measure: Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.
timeFrame: approximately 3 months
measure: Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.
timeFrame: approximately 3 months
Secondary outcomes:
measure: Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.
timeFrame: approximately 4 months
measure: Change in Pain Intensity Measured by the Brief Pain Inventory - Severity
timeFrame: Baseline and 48 hours prior to discharge from hospital
measure: Change in Pain Intensity Measured by the Brief Pain Inventory - Interference
timeFrame: Baseline and 48 hours prior to discharge from hospital
measure: Change in Depression Measured by the Patient Health Questionnaire
timeFrame: Baseline and 48 hours prior to discharge from hospital
measure: Patient Satisfaction Measured Using a Patient Satisfaction Survey
timeFrame: 48 hours prior to discharge from hospital
measure: Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization
timeFrame: up to 30 days post hospitalization
measure: Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization
timeFrame: up to 30 days post hospitalization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital, 20 York Street
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital, 1450 Chapel Street
state: Connecticut
Study officials:
affiliation: Yale University
name: Melissa Weimer, DO, MCR, FASAM
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Alexandra Hajduk, PhD
role: PRINCIPAL_INVESTIGATOR
References: