NCT03986866

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

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

April 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

June 5, 2019

Results QC Date

December 13, 2021

Last Update Submit

March 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    7 days

  • 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.

    Up to 3 months

Secondary Outcomes (2)

  • Development of Chronic Opioid Use

    90-150 days

  • Number of Total Days to Opioid Cessation

    Up to 3 months

Study Arms (2)

No Video

NO INTERVENTION

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

Video

EXPERIMENTAL

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

Other: Video

Interventions

VideoOTHER

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.

Video

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (20)

  • 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.

    PMID: 27025001BACKGROUND
  • 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.

    PMID: 3319971BACKGROUND
  • 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.

    PMID: 28403427BACKGROUND
  • 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.

    PMID: 28873050BACKGROUND
  • 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.

    PMID: 27484682BACKGROUND
  • 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.

    PMID: 19515102BACKGROUND
  • 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.

    PMID: 29509867BACKGROUND
  • 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.

    PMID: 26359332BACKGROUND
  • 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.

    PMID: 29498951BACKGROUND
  • 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.

    PMID: 11304773BACKGROUND
  • 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.

    PMID: 26654958BACKGROUND
  • 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.

    PMID: 30095765BACKGROUND
  • 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.

    PMID: 29406338BACKGROUND
  • Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.

    PMID: 16100861BACKGROUND
  • 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.

    PMID: 28301454BACKGROUND
  • 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.

    PMID: 16430605BACKGROUND
  • 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.

    PMID: 30149041BACKGROUND
  • 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.

    PMID: 29215369BACKGROUND
  • 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.

    PMID: 25936786BACKGROUND
  • 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.

    PMID: 11189670BACKGROUND

Related Links

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Results Point of Contact

Title
Johnathan Goree, MD
Organization
University of Arkansas for Medical Sciences

Study Officials

  • Johnathan H Goree, M.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR
  • Lauren Byers, APRN

    University of Arkansas

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 14, 2019

Study Start

April 29, 2019

Primary Completion

March 31, 2020

Study Completion

April 1, 2020

Last Updated

April 26, 2022

Results First Posted

April 26, 2022

Record last verified: 2021-12

Locations