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

Not Applicable

Completed

Conditions: Chronic Pain
Opioid Dependence

Interventions: Other: Enhanced Opioid Stewardship Program

Registration Number: NCT05370326

Lead Sponsor: Yale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Opioid Stewardship Program	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment	approximately 3 months	Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.	approximately 3 months	Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention.
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.	approximately 3 months	Number of participants in the intervention group who were able to complete the peri-discharge evaluation to determine retention.
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment	approximately 3 months	Feasibility of recruitment will be determined by a count of the number of participants eligible for the study compared to number of enrolled participants.
Days to Hospital Day of Enrollment	approximately 3 months	Days to hospital day of enrollment in relation to admission and discharge dates
Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention	approximately 3 months	Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention to determine retention

Secondary Outcome Measures

Name	Time	Method
Change in Depression Measured by the Patient Health Questionnaire	Baseline and 48 hours prior to discharge from hospital	The Patient Health Questionnaire measures Change in depression. Scores range from 0 (no depression) to 27 (severe depression).
Patient Satisfaction Measured Using a Patient Satisfaction Survey	48 hours prior to discharge from hospital	Patient satisfaction will be measured using a Likert scale with scores ranging from a scale of 1-5 (1 not satisfied, 5 very satisfied). These data were not collected as part of the completed study.
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization	up to 30 days post hospitalization	The Number of participants with hospital re-admissions at 30 days after hospitalization. Outcome was updated upon results entry.
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization	up to 30 days post hospitalization	The count of participants with emergency department visits at 30 days after hospitalization. The outcome was updated when results were entered.
Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.	approximately 4 months	A a count of guideline-based care elements considered to be "best practices" for opioid stewardship in the setting of chronic pain will be collected during hospitalizations. These include ordering of alternative pain relief medications (e.g., acetaminophen), ordering of a bowel regimen, ordering of medication to treat opioid use disorder, order of urine toxicology screen, ordering of ECG for patients prescribed methadone, avoidance of co-prescriptions of benzodiazepines, and other associate "best care" practices. These metrics will be abstracted from the medical record. The number is out of a possible 12 recommendations- 12 would be the most recommendations a participant could have received.
Change in Pain Intensity Measured by the Brief Pain Inventory - Severity	Baseline and 48 hours prior to discharge from hospital	The Brief Pain Inventory measures the intensity of pain, along with the degree to which the pain interferes with the everyday functioning of life. Scores range from 0 (no pain) to 10 (severe pain).
Change in Pain Intensity Measured by the Brief Pain Inventory - Interference	Baseline and 48 hours prior to discharge from hospital	The Brief Pain Inventory measures the intensity of pain, along with the degree to which the pain interferes with the everyday functioning of life. Scores range from 0 (no life interference) to 10 (complete interference).

Trial Locations

Locations (2): Yale New Haven Hospital, 1450 Chapel Street
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New Haven, Connecticut, United States
Yale New Haven Hospital, 20 York Street
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New Haven, Connecticut, United States