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

NCT05370326 | Completed Results DMC

• 2 other identifiers: 20000326381RM1DA055310-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid Dependence; Chronic Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.

  approximately 4 months

• Change in Pain Intensity Measured by the Brief Pain Inventory - Severity

  Baseline and 48 hours prior to discharge from hospital

• Change in Pain Intensity Measured by the Brief Pain Inventory - Interference

  Baseline and 48 hours prior to discharge from hospital

• Change in Depression Measured by the Patient Health Questionnaire

  Baseline and 48 hours prior to discharge from hospital

• Patient Satisfaction Measured Using a Patient Satisfaction Survey

  48 hours prior to discharge from hospital

Study Arms (2)

Enhanced Opioid Stewardship Program

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

Interventions

Enhanced Opioid Stewardship Program OTHER

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.

Enhanced Opioid Stewardship Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Yale New Haven Hospital, 20 York Street

New Haven, Connecticut, 06510, United States

Location

Yale New Haven Hospital, 1450 Chapel Street

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melissa B. Weimer, DO, MCR, DFASAM
• Organization: Yale School of Medicine

melissa.weimer@yale.edu

(203) 859-2962

Study Officials

• Melissa Weimer, DO, MCR, FASAM

  Yale University

  PRINCIPAL INVESTIGATOR

• Alexandra Hajduk, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 11, 2022
• Study Start: July 7, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: March 5, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)