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

Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Dependence
• Intervention / Treatment: Other: Enhanced Opioid Stewardship Program

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital, 20 York Street
    • New Haven, Connecticut, United States, 06511
      • Yale New Haven Hospital, 1450 Chapel Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
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	Other: Enhanced Opioid Stewardship Program; The goal of the enhanced opioid stewardship intervention is to manage chronic pain while reducing risk of inappropriate/risky opioid use and preventing harms of opioid use.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.	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.	approximately 4 months
Change in Pain Intensity Measured by the Brief Pain Inventory - Severity	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).	Baseline and 48 hours prior to discharge from hospital
Change in Pain Intensity Measured by the Brief Pain Inventory - Interference	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).	Baseline and 48 hours prior to discharge from hospital
Change in Depression Measured by the Patient Health Questionnaire	The Patient Health Questionnaire measures Change in depression. Scores range from 0 (no depression) to 27 (severe depression).	Baseline and 48 hours prior to discharge from hospital
Patient Satisfaction Measured Using a Patient Satisfaction Survey	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.	48 hours prior to discharge from hospital
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization	The Number of participants with hospital re-admissions at 30 days after hospitalization. Outcome was updated upon results entry.	up to 30 days post hospitalization
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization	The count of participants with emergency department visits at 30 days after hospitalization. The outcome was updated when results were entered.	up to 30 days post hospitalization

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Melissa Weimer, DO, MCR, FASAM, Yale University; Principal Investigator: Alexandra Hajduk, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2000032638; 1RM1DA055310-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No