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Clinical Trials/NCT04918446
NCT04918446
Completed
Not Applicable

Technology-Assisted Prescription Opioid Safety Education (T-POSE)

West Virginia University2 sites in 1 country96 target enrollmentMarch 29, 2018
ConditionsOpioid Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
West Virginia University
Enrollment
96
Locations
2
Primary Endpoint
Occurrence of Non-Medical Use of a Prescription Opioid
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study will develop a technology-based brief educational intervention for hospitalized patients that will be discharged with an opioid prescription. The Investigators will conduct a small randomized clinical trial of T-POSE to determine whether it improves patients: knowledge and reduces the incidence of Non-Medical Prescription Opioid Use (NMPOU).

Detailed Description

Non-medical use of prescription opioids (NMPOU) can be generally defined as not taking opioids as prescribed, which could occur unintentionally or intentionally. In 2014, 4.3 million adults in the United States (U.S.) were estimated to engage in NMPOU (Center for Behavioral Health Statistics and Quality 2014). Some patients may take a dose more frequently than prescribed because they were not receiving adequate pain relief from the prescribed dosage. While others may continue to take opioids longer than prescribed because their pain is persistent and/or they like the euphoric effects of opioids. According to a recently released Truven Health Analytics-NPR Health Poll, the majority (57%) of Americans have taken a prescription opioid and 35% of those had concerns (e.g., addiction, effectiveness, side effects) about prescription opioids. These findings suggest that while Americans are aware, some even concerned, of the potential dangers associated with prescription opioids that their utilization patterns continue to increase (Boddy 2017). Because opioids are prescribed by a physician, patients may believe that these medications are safe and they may be unaware of the risks associated with misuse and abuse of opioids. NMPOU may lead to increased risk of drug overdose, addiction, diversion and use of heroin. Many individuals with opioid use disorders initiated NMPOU before transitioning to heroin (Banerjee et al. 2016; Cerda et al. 2015) and report that their first exposure to an opioid was prescribed by a physician. This underscores the need for empirically-tested educational interventions that can potentially reduce NMPOU and diversion. Prescription opioids have an important role to play in health care and blanket policies to restrict access to prescription opioids are not appropriate, rather the hypothesis is that harm can be reduced by fundamentally changing our approach to opioid medication safety.

Registry
clinicaltrials.gov
Start Date
March 29, 2018
End Date
February 13, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erin Winstanley

Associate Professor

West Virginia University

Eligibility Criteria

Inclusion Criteria

  • Subject is being discharged from the hospital with a prescription opioid
  • English Speaking
  • Willing and able to use a tablet
  • Phase II Inclusion Criteria:
  • Willing and able to provide informed written consent
  • Subject is being discharged from the hospital with a prescription opioid
  • English Speaking
  • Willing and able to use a tablet

Exclusion Criteria

  • Visual or hearing impediment that would inhibit communication with the Study Pharmacist and use of the laptop
  • Cognitive or mental state prohibiting informed consent
  • Patient reported opioid use disorder

Outcomes

Primary Outcomes

Occurrence of Non-Medical Use of a Prescription Opioid

Time Frame: Up to 90 days post intervention

Self report of Yes or No to follow up questions about prescription opioid use. Yes= occurrence of Non-Medical Use of a Prescription Opioid.

Secondary Outcomes

  • Occurrence of retention of knowledge on how to safe use of prescription opioids(Up to 90 days post intervention)
  • Number of patients reporting patient satisfaction(Up to 90 days post intervention)
  • Reasons for non-medical use of prescription opioids(Up to 90 days post intervention)

Study Sites (2)

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