NCT04918446

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

August 12, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 3, 2021

Last Update Submit

August 4, 2021

Conditions

Keywords

Non-Medical Prescription Opioid Use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (2)

T-POSE

EXPERIMENTAL

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

Other: T-POSE

Usual Care

OTHER

Standard discharge instructions provided.

Other: Usual Care

Interventions

T-POSEOTHER

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

T-POSE

Printed instruction sheets on prescribed opioid.

Usual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cabell Huntington Hospital (Marshall University)

Huntington, West Virginia, 25755, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26505, United States

Location

Study Officials

  • Erin Winstanley, PhD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A small pilot study using a randomized clinical trial of T-POSE compared to usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

March 29, 2018

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

August 12, 2021

Record last verified: 2021-06

Locations