Technology-Assisted Prescription Opioid Safety Education

NCT ID: NCT04918446

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2019-02-13

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.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

T-POSE

Technology based brief educational intervention for hospitalized patients that will be discharged with an opioid prescription.

Group Type: EXPERIMENTAL

T-POSE

Intervention Type: OTHER

Tablet based education and videos on opioid safety, use, and storage/disposal of the drug.

Usual Care

Standard discharge instructions provided.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Printed instruction sheets on prescribed opioid.

Interventions

T-POSE

Tablet based education and videos on opioid safety, use, and storage/disposal of the drug.

Intervention Type: OTHER

Usual Care

Printed instruction sheets on prescribed opioid.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject is being discharged from the hospital with a prescription opioid
• English Speaking
• Willing and able to use a tablet

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Erin Winstanley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Winstanley, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Cabell Huntington Hospital (Marshall University)

Huntington, West Virginia, United States

West Virginia University Hospitals

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

1705563584

Identifier Type: -

Identifier Source: org_study_id