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

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

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).

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Other: T-POSE; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25755
      • Cabell Huntington Hospital (Marshall University)
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Phase I 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-POSE; Technology based brief educational intervention for hospitalized patients that will be discharged with an opioid prescription.	Other: T-POSE; Tablet based education and videos on opioid safety, use, and storage/disposal of the drug.
Other: Usual Care; Standard discharge instructions provided.	Other: Usual Care; Printed instruction sheets on prescribed opioid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Non-Medical Use of a Prescription Opioid	Self report of Yes or No to follow up questions about prescription opioid use. Yes= occurrence of Non-Medical Use of a Prescription Opioid.	Up to 90 days post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of retention of knowledge on how to safe use of prescription opioids	The number of times that a patient reports retention of materials presented.	Up to 90 days post intervention
Number of patients reporting patient satisfaction	Overall number of subjects satisfied with T-POSE, as measured by a 5-point Patient Satisfaction questionnaire.	Up to 90 days post intervention
Reasons for non-medical use of prescription opioids	Investigators recorded reasons for non-medical us of prescription opioids.	Up to 90 days post intervention

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Erin Winstanley, PhD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Non-Medical Prescription Opioid Use
• Other Study ID Numbers: 1705563584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No