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

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ClinicalTrials.gov Identifier: NCT03986866
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Opioid Use Chronic Pain Post-Procedural Other: Video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Video-based, Patient-Focused Opioid Education in the Perioperative Period: A Feasibility Study
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2019

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.




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Up to 3 months ]
    Satisfaction as determined by the post-op phone calls

  2. Knowledge Acquisition [ Time Frame: Up to a week ]
    Knowledge acquisition as determined by the post-op day 7 phone calls (knowledge measured on a scale of 1-10, with 1 being not at all informed and 10 being very informed)

  3. Post-operative Pain Control [ Time Frame: Up to 3 months ]
    Post-operative pain control as determined by opioids and other pain medications


Secondary Outcome Measures :
  1. Development of Chronic Opioid Use [ Time Frame: Up to 3 months ]
    Feasibility of collecting data on the percentage of patients who develop chronic opioid use

  2. Development of Chronic Post-surgical Pain Disorder [ Time Frame: Up to 3 months ]
    Feasibility of collecting data on the percentage of patients who develop a chronic post-surgical pain disorder

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986866


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Johnathan H Goree, M.D. University of Arkansas
Study Chair: Lauren Byers, APRN University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Informed Consent Form  [PDF] December 18, 2018


Publications:

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03986866     History of Changes
Other Study ID Numbers: 228789
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents