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

NCT ID: NCT03986866

Last Updated: 2022-04-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Chronic Pain Post-Procedural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Video

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Video

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

Group Type EXPERIMENTAL

Video

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johnathan H Goree, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Lauren Byers, APRN

Role: STUDY_CHAIR

University of Arkansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Ayasrah SM, Ahmad MM. Educational Video Intervention Effects on Periprocedural Anxiety Levels Among Cardiac Catheterization Patients: A Randomized Clinical Trial. Res Theory Nurs Pract. 2016;30(1):70-84. doi: 10.1891/1541-6577.30.1.70.

Reference Type BACKGROUND
PMID: 27025001 (View on PubMed)

Basch CE. Focus group interview: an underutilized research technique for improving theory and practice in health education. Health Educ Q. 1987 Winter;14(4):411-48. doi: 10.1177/109019818701400404.

Reference Type BACKGROUND
PMID: 3319971 (View on PubMed)

Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

Reference Type BACKGROUND
PMID: 28403427 (View on PubMed)

Chakravarthy B, Somasundaram S, Mogi J, Burns R, Hoonpongsimanont W, Wiechmann W, Lotfipour S. Randomized pilot trial measuring knowledge acquisition of opioid education in emergency department patients using a novel media platform. Subst Abus. 2018 Jan 2;39(1):27-31. doi: 10.1080/08897077.2017.1375061. Epub 2017 Sep 29.

Reference Type BACKGROUND
PMID: 28873050 (View on PubMed)

Deyo RA, Hallvik SE, Hildebran C, Marino M, Dexter E, Irvine JM, O'Kane N, Van Otterloo J, Wright DA, Leichtling G, Millet LM. Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naive Patients: A Statewide Retrospective Cohort Study. J Gen Intern Med. 2017 Jan;32(1):21-27. doi: 10.1007/s11606-016-3810-3. Epub 2016 Aug 2.

Reference Type BACKGROUND
PMID: 27484682 (View on PubMed)

Hill AM, McPhail S, Hoffmann T, Hill K, Oliver D, Beer C, Brauer S, Haines TP. A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital. J Am Geriatr Soc. 2009 Aug;57(8):1458-63. doi: 10.1111/j.1532-5415.2009.02346.x. Epub 2009 Jun 8.

Reference Type BACKGROUND
PMID: 19515102 (View on PubMed)

Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.

Reference Type BACKGROUND
PMID: 29509867 (View on PubMed)

Meissner W, Coluzzi F, Fletcher D, Huygen F, Morlion B, Neugebauer E, Montes A, Pergolizzi J. Improving the management of post-operative acute pain: priorities for change. Curr Med Res Opin. 2015 Nov;31(11):2131-43. doi: 10.1185/03007995.2015.1092122. Epub 2015 Sep 30.

Reference Type BACKGROUND
PMID: 26359332 (View on PubMed)

Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.

Reference Type BACKGROUND
PMID: 29498951 (View on PubMed)

Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. J Clin Oncol. 2001 Apr 15;19(8):2206-12. doi: 10.1200/JCO.2001.19.8.2206.

Reference Type BACKGROUND
PMID: 11304773 (View on PubMed)

Pereira L, Figueiredo-Braga M, Carvalho IP. Preoperative anxiety in ambulatory surgery: The impact of an empathic patient-centered approach on psychological and clinical outcomes. Patient Educ Couns. 2016 May;99(5):733-8. doi: 10.1016/j.pec.2015.11.016. Epub 2015 Nov 26.

Reference Type BACKGROUND
PMID: 26654958 (View on PubMed)

Prabhu M, Dubois H, James K, Leffert LR, Riley LE, Bateman BT, Henderson M. Implementation of a Quality Improvement Initiative to Decrease Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2018 Sep;132(3):631-636. doi: 10.1097/AOG.0000000000002789.

Reference Type BACKGROUND
PMID: 30095765 (View on PubMed)

Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.

Reference Type BACKGROUND
PMID: 29406338 (View on PubMed)

Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.

Reference Type BACKGROUND
PMID: 16100861 (View on PubMed)

Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use - United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 17;66(10):265-269. doi: 10.15585/mmwr.mm6610a1.

Reference Type BACKGROUND
PMID: 28301454 (View on PubMed)

Sobo EJ, Seid M, Reyes Gelhard L. Parent-identified barriers to pediatric health care: a process-oriented model. Health Serv Res. 2006 Feb;41(1):148-72. doi: 10.1111/j.1475-6773.2005.00455.x.

Reference Type BACKGROUND
PMID: 16430605 (View on PubMed)

Theisen KM, Myrga JM, Hale N, Cochran G, Sewall C, Macleod LC, Jacobs BL, Davies BJ. Excessive Opioid Prescribing After Major Urologic Procedures. Urology. 2019 Jan;123:101-107. doi: 10.1016/j.urology.2018.06.057. Epub 2018 Aug 24.

Reference Type BACKGROUND
PMID: 30149041 (View on PubMed)

Thiels CA, Hanson KT, Cima RR, Habermann EB. From Data to Practice: Increasing Awareness of Opioid Prescribing Data Changes Practice. Ann Surg. 2018 Mar;267(3):e46-e47. doi: 10.1097/SLA.0000000000002623.

Reference Type BACKGROUND
PMID: 29215369 (View on PubMed)

Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.

Reference Type BACKGROUND
PMID: 25936786 (View on PubMed)

Watt-Watson J, Stevens B, Costello J, Katz J, Reid G. Impact of preoperative education on pain management outcomes after coronary artery bypass graft surgery: a pilot. Can J Nurs Res. 2000 Mar;31(4):41-56.

Reference Type BACKGROUND
PMID: 11189670 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

228789

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Perioperative Pain Self-Management Program Trial
NCT04979429 ACTIVE_NOT_RECRUITING NA
Pain in Breast Surgery Intervention
NCT04058938 COMPLETED NA
Pilot Trial: Postoperative Opioid-free Analgesia
NCT04254679 COMPLETED PHASE2/PHASE3
Pain Management in Outpatient Urologic Procedures
NCT03393364 COMPLETED EARLY_PHASE1
Opioid-Free Orthopaedics
NCT04659317 RECRUITING PHASE3