Video-based, Patient-Focused Opioid Education in the Perioperative Period
3. mars 2022 oppdatert av: University of Arkansas
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
110
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: No Video
Patients are not shown the informational video on the safe usage of opioids.
|
|
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Eksperimentell: Video
Patients are shown an informational video on the safe usage of opioids.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knowledge of Post Operative Opioids
Tidsramme: 7 days
|
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.
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7 days
|
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Number of Patients Who Discontinued Opioids by 3 Months
Tidsramme: Up to 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Development of Chronic Opioid Use
Tidsramme: 90-150 days
|
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.
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90-150 days
|
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Number of Total Days to Opioid Cessation
Tidsramme: Up to 3 months
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Feasibility of collecting data on the number of days until opioid cessation
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Up to 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Johnathan H Goree, M.D., University of Arkansas
- Studiestol: Lauren Byers, APRN, University of Arkansas
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Curr Med Res Opin. 2016 May;32(5):979.
- 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.
- 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.
- 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.
- Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.
- 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.
- 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.
- 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.
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. april 2019
Primær fullføring (Faktiske)
31. mars 2020
Studiet fullført (Faktiske)
1. april 2020
Datoer for studieregistrering
Først innsendt
5. juni 2019
Først innsendt som oppfylte QC-kriteriene
12. juni 2019
Først lagt ut (Faktiske)
14. juni 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mars 2022
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 228789
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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