AzTrials
AzTrials

Opioid UseNCT03986866

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

A study testing Video in people with Opioid Use and Chronic Pain Post-Procedural, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use, Chronic Pain Post-Procedural
What is being tested?
Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
29 Apr 2019to 1 Apr 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Video

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03986866
Study groupRoleWhat they receive
No VideoNo interventionPatients are not shown the informational video on the safe usage of opioids.
VideoExperimentalPatients are shown an informational video on the safe usage of opioids.
Receives: Other: Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 days

  2. 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.

    Measured: Up to 3 months

Secondary outcomes (2)

  1. 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.

    Measured: 90-150 days

  2. Number of Total Days to Opioid Cessation

    Feasibility of collecting data on the number of days until opioid cessation

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start29 Apr 2019
  3. Primary completion31 Mar 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986866
Sponsor's protocol ID
228789
Status last verified
Dec 2021
First submitted
5 Jun 2019
Last updated
26 Apr 2022
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27025001

  • 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.

    PubMed 3319971

  • 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.

    PubMed 28403427

  • 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.

    PubMed 28873050

  • 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.

    PubMed 27484682

  • 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.

    PubMed 19515102

  • 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.

    PubMed 29509867

  • 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.

    PubMed 26359332

  • 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.

    PubMed 29498951

  • 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.

    PubMed 11304773

  • 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.

    PubMed 26654958

  • 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.

    PubMed 30095765

  • 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.

    PubMed 29406338

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

    PubMed 16100861

  • 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.

    PubMed 28301454

Questions about this trial

What is this clinical trial studying?

A study testing Video in people with Opioid Use and Chronic Pain Post-Procedural, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of Post Operative Opioids (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986866, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in