Enhanced Opioid Stewardship Program for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale New Haven Hospital, 20 York Street, New Haven, CT
Chronic Pain+2 More
Enhanced Opioid Stewardship Program - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Chronic Pain
  • Opioid Dependence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: up to 5 months

Hour 48
Patient satisfaction measured using a patient satisfaction survey
Hour 48
Change in Pain intensity measured by the Brief Pain Inventory
Change in depression measured by the Patient Health Questionnaire
Month 5
Days to hospital day of enrollment
Month 5
Number of guideline-based care elements in use considered guideline concordant care with opioids for pain during hospitalization.
Day 30
Number of emergency department visits at 30 days after hospitalization
Number of hospital re-admissions at 30 days after hospitalization
up to 5 months
Number of eligible participants compared to number of enrolled participants to determine Feasibility of recruitment
Number of participants in control group who complete the peri-discharge evaluation.
Number of participants in intervention group who complete the peri-discharge evaluation.
Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention
Number of participants screened compared to number of eligible participants to determine Feasibility of recruitment

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of care
1 of 2
Enhanced Opioid Stewardship Program
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced Opioid Stewardship Program · No Placebo Group · N/A

Enhanced Opioid Stewardship Program
Other
Experimental Group · 1 Intervention: Enhanced Opioid Stewardship Program · Intervention Types: Other
Standard of careNoIntervention Group · 1 Intervention: Standard of care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 months
Closest Location: Yale New Haven Hospital, 20 York Street · New Haven, CT
Photo of New Haven 1Photo of New Haven 2Photo of New Haven 3
2022First Recorded Clinical Trial
1 TrialsResearching Chronic Pain
1 CompletedClinical Trials

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,653 Previous Clinical Trials
20,829,864 Total Patients Enrolled
14 Trials studying Chronic Pain
2,634 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,379 Total Patients Enrolled
44 Trials studying Chronic Pain
61,542 Patients Enrolled for Chronic Pain
Alexandra Hajduk, PhDPrincipal InvestigatorYale University
Melissa Weimer, DO, MCR, FASAMPrincipal InvestigatorYale University

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are admitted to the Yale New Haven Hospital on medical units.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.