Video-based, Patient-Focused Opioid Education in the Perioperative Period

March 3, 2022 updated by: University of Arkansas

Video-based, Patient-Focused Opioid Education in the Perioperative Period: A Feasibility Study

This is a pilot study designed to assess the feasibility of using a novel, video-based opioid education tool for opioid naïve ambulatory surgery patients in the perioperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized to a video or no video prior to surgery then administered a phone questionnaire at post-op day 7, 30, and 90. The Arkansas Prescriptions Drug Monitoring Database will also be accessed for information on opioid prescription refills. The overall goal of the study is to evaluate the effect that video-based opioid education has on narcotic intake after outpatient surgery. The duration of the study will be approximately 3 months, plus a single 1-hour long focus group if desired by the patient.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 years or older
  • Not chronically receiving opioid analgesics
  • Patients who have not taken opioids 30 days pre-operatively
  • Undergoing surgical procedure not requiring overnight hospital stay

Exclusion Criteria:

  • Non-English speaking
  • Legally deaf or blind
  • On opiate contract
  • Has taken oral narcotic in the past 30 days
  • Unable to operate a telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Video
Patients are not shown the informational video on the safe usage of opioids.
Experimental: Video
Patients are shown an informational video on the safe usage of opioids.
Other: Video
A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Post Operative Opioids
Time Frame: 7 days
Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.
7 days
Number of Patients Who Discontinued Opioids by 3 Months
Time Frame: Up to 3 months
Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Chronic Opioid Use
Time Frame: 90-150 days
Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively.
90-150 days
Number of Total Days to Opioid Cessation
Time Frame: Up to 3 months
Feasibility of collecting data on the number of days until opioid cessation
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Johnathan H Goree, M.D., University of Arkansas
  • Study Chair: Lauren Byers, APRN, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228789

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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