Educational materials for Opioids Use

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Opioids Use
Educational materials - Other
Eligibility
18+
All Sexes
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Study Summary

Opioid medications are widely used after many orthopedic procedures and are routinely prescribed after shoulder replacement surgery. Despite the high prevalence of opioid abuse and misuse, there is no standardized mechanism for patients to dispose of unused opioid medications safely and securely and the average number of opioid pills required after shoulder replacement surgery is still unknown. In a prior pilot study conducted by our group (IRB# 202012142), opioid consumption patterns of patients undergoing shoulder arthroplasty were analyzed, as well as their adherence to a safe and secure disposal mechanism for excess opioid pills. A 94% retention rate was achieved and preliminary results showed that most of the subjects were 60 years of age and older. The objective of the current proposal is to: (1) develop pre-operative education materials related to post-operative opioid use following shoulder arthroplasty; (2) pilot the impact of this educational intervention; (3) examine the effect of providing disposal mechanisms for unused opioid pain medications following shoulder arthroplasty. The proposal is to conduct a single blinded randomized controlled trial of patients undergoing total shoulder replacement, both anatomic total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA), and Hemiarthroplasty at UIHC. This randomized controlled trial will compare: (1) education plus opioid disposal to the standard of care (SC). The investigators hypothesize that pre-operative opioid education modules combined with a structured opioid disposal program will decrease opioid consumption following shoulder arthroplasty.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Immediately after the surgical procedure

Immediately after the surgical procedure
Opioid consumption with and without pre-operative opioid education
Opioid disposal

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control/Standard of Care
1 of 2
Education Arm
1 of 2
Active Control
Experimental Treatment

136 Total Participants · 2 Treatment Groups

Primary Treatment: Educational materials · No Placebo Group · N/A

Education Arm
Other
Experimental Group · 1 Intervention: Educational materials · Intervention Types: Other
Control/Standard of CareNoIntervention Group · 1 Intervention: Control/Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after the surgical procedure
Closest Location: University of Iowa · Iowa City, IA
Photo of University of Iowa 1Photo of University of Iowa 2Photo of University of Iowa 3
1993First Recorded Clinical Trial
2 TrialsResearching Opioids Use
451 CompletedClinical Trials

Who is running the clinical trial?

Brendan M. PattersonLead Sponsor
Brendan M PattersonPrincipal InvestigatorUniversity of Iowa

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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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.

References