Clinical trial NCT04918446: Technology-Assisted Prescription Opioid Safety Education
Official title: Technology-Assisted Prescription Opioid Safety Education (T-POSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: Non-Medical Prescription Opioid Use
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A small pilot study using a randomized clinical trial of T-POSE compared to usual care.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Non-Medical Use of a Prescription Opioid
timeFrame: Up to 90 days post intervention
Secondary outcomes:
measure: Occurrence of retention of knowledge on how to safe use of prescription opioids
timeFrame: Up to 90 days post intervention
measure: Number of patients reporting patient satisfaction
timeFrame: Up to 90 days post intervention
measure: Reasons for non-medical use of prescription opioids
timeFrame: Up to 90 days post intervention
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Cabell Huntington Hospital (Marshall University)
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Erin Winstanley, PhD
role: PRINCIPAL_INVESTIGATOR
References: