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

Primary Purpose

Opioid Use, Chronic Pain Post-Procedural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Video

Video

Arm Description

Patients are not shown the informational video on the safe usage of opioids.

Patients are shown an informational video on the safe usage of opioids.

Outcomes

Primary Outcome Measures

Knowledge of Post Operative Opioids
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.
Number of Patients Who Discontinued Opioids by 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.

Secondary Outcome Measures

Development of Chronic Opioid Use
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.
Number of Total Days to Opioid Cessation
Feasibility of collecting data on the number of days until opioid cessation

Full Information

First Posted
June 5, 2019
Last Updated
March 3, 2022
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03986866
Brief Title
Video-based, Patient-Focused Opioid Education in the Perioperative Period
Official Title
Video-based, Patient-Focused Opioid Education in the Perioperative Period: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Chronic Pain Post-Procedural

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Video
Arm Type
No Intervention
Arm Description
Patients are not shown the informational video on the safe usage of opioids.
Arm Title
Video
Arm Type
Experimental
Arm Description
Patients are shown an informational video on the safe usage of opioids.
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of Post Operative Opioids
Description
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.
Time Frame
7 days
Title
Number of Patients Who Discontinued Opioids by 3 Months
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Development of Chronic Opioid Use
Description
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.
Time Frame
90-150 days
Title
Number of Total Days to Opioid Cessation
Description
Feasibility of collecting data on the number of days until opioid cessation
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnathan H Goree, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Byers, APRN
Organizational Affiliation
University of Arkansas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8403019/pdf/jpr-14-2583.pdf
Description
Publication

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

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