N/A N=52 Randomized Other

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

Opioid Dependence · Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT05370326 ↗

Enrolled (actual)

Serious AEs

1.9%

Results posted

Jan 2024

Primary outcome: Primary: Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment — 97; 62; 351 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Enhanced Opioid Stewardship Program (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment	97; 62; 351	—
PRIMARY Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment	22; 52; 23	—
PRIMARY Days to Hospital Day of Enrollment	9.66; 10.56	0.69
PRIMARY Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention	36	—
PRIMARY Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.	36; 31	—
PRIMARY Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.	16; 14	—
SECONDARY Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.	4.4	—
SECONDARY Change in Pain Intensity Measured by the Brief Pain Inventory - Severity	-0.46; -0.23	0.67
SECONDARY Change in Pain Intensity Measured by the Brief Pain Inventory - Interference	-1.21; -0.62	0.50
SECONDARY Change in Depression Measured by the Patient Health Questionnaire	-0.56; -0.35	0.74
SECONDARY Patient Satisfaction Measured Using a Patient Satisfaction Survey	—	—
SECONDARY Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization	14; 4; 22; 12	0.33
SECONDARY Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization	15; 5; 21; 11	0.47

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05370326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.