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OpenTrials
Completed

NCT Number: NCT04918446

Technology-Assisted Prescription Opioid Safety Education

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).

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabell Huntington Hospital (Marshall University), Huntington, West Virginia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-POSE

Other

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

Usual Care

Other

Printed instruction sheets on prescribed opioid.

Primary outcomes

  1. 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

  1. Occurrence of retention of knowledge on how to safe use of prescription opioids

    Time frame: Up to 90 days post intervention

    The number of times that a patient reports retention of materials presented.

  2. Number of patients reporting patient satisfaction

    Time frame: Up to 90 days post intervention

    Overall number of subjects satisfied with T-POSE, as measured by a 5-point Patient Satisfaction questionnaire.

  3. Reasons for non-medical use of prescription opioids

    Time frame: Up to 90 days post intervention

    Investigators recorded reasons for non-medical us of prescription opioids.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Acronym: T-POSE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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