A Difference-In-Differences Analysis of New Persistent Opioid Use After Surgery
15 marzo 2021 aggiornato da: Chad Brummett, University of Michigan
Using Difference-in-Differences to Evaluate the Effect of a Statewide Quality Improvement Program on New Persistent Opioid Use After Surgery
The Michigan Opioid Prescribing and Engagement Network (M-OPEN) was established in 2016 with the goal of reducing excessive opioid prescribing after surgery using evidence-based prescribing guidelines.
Beginning in July 2016, M-OPEN began a statewide quality improvement campaign to educate providers and share prescribing best practices.
This retrospective study examines the effect of these efforts on new persistent opioid use after surgery compared to other states where no such program existed using a difference-in-differences approach.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In the United States, surgical care has become a gateway for chronic opioid dependence and its associated morbidity. Between 5-10% of patients who receive opioids for postoperative pain control go on to develop long-term opioid use. This translates to more than 2 million previously opioid-naïve individuals developing chronic opioid use after surgery each year. Persistent opioid use after surgery is associated with increased readmissions, healthcare utilization, and healthcare expenditures. Critically, long-term opioid use increases the risk of overdose and death in patients who, prior to their surgery, had no exposure to opioids.
Growing recognition of this problem has led to numerous efforts aimed at reducing opioid-associated morbidity after surgery. These include legislative limits on opioid prescribing for acute pain, procedure-specific prescribing guidelines based on patient-reported opioid use, and opioid-sparing pain management pathways. In Michigan specifically, the Michigan Opioid Prescribing and Engagement Network (M-OPEN) led a statewide quality improvement effort beginning in 2016 that focused on provider education using evidence-based opioid prescribing guidelines. Previously, these guidelines have been shown to significantly reduce excessive postoperative opioid prescribing across the state, however it is currently unknown whether these efforts have had any effect on the actual incidence of persistent opioid use after surgery.
Therefore, the current study will evaluate the incidence of new persistent opioid use before and after the establishment of M-OPEN in Michigan. Beginning in 2016, a statewide quality improvement initiative was undertaken in Michigan to improve postoperative opioid prescribing. In order to accomplish this goal, this study will use a difference-in-differences approach to compare new persistent opioid use in Michigan before and after 2016 to other states where no such quality improvement effort existed.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
30000
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Data for this study will be obtained from the Truven Health MarketScan database, which is a national data set of employer-based insurance claims.
Patients in the database who underwent one of the eligible procedures will be identified using Current Procedural Terminology codes that correspond to the specific operations under analysis.
Descrizione
Inclusion Criteria:
- Adult patients (18 years and older)
- Patients undergoing one of the following procedures: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy
- Patients who underwent surgery between January 1, 2013 and December 31, 2019
Exclusion Criteria:
- Patients who are not opioid-naive at the time of surgery, defined as filling 1 or more opioid prescriptions between the 12 months to 31 days prior to surgery
- Patients without continuous insurance enrollment for at least 12 months before and at least 6 months after the date of surgery
- Patients still in the hospital on postoperative day 30
- Patients not discharged home after surgery
- Patients who underwent another surgery within 6 months of their index operation
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Patients undergoing surgery
Retrospective cohort of patients who underwent surgery between 1/1/13 to 12/31/19 and were sampled from the Truven Health MarketScan Database.
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Retrospective analysis of opioid use after one of the following surgical procedure categories: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states.
Lasso di tempo: Postoperative days 4 to 180
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Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180.
This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and all other states (the difference-in-differences).
Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
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Postoperative days 4 to 180
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to Indiana and Wisconsin
Lasso di tempo: Postoperative days 4 to 180
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Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180.
This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and Indiana/Wisconsin (the difference-in-differences).
Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
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Postoperative days 4 to 180
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The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to 11 other Midwest states (Illinois, Indiana, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin).
Lasso di tempo: Postoperative days 4 to 180
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Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180.
This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and 11 other Midwest states.
Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.
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Postoperative days 4 to 180
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Chad Brummett, MD, University of Michigan
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- Lee JS, Hu HM, Edelman AL, Brummett CM, Englesbe MJ, Waljee JF, Smerage JB, Griggs JJ, Nathan H, Jeruss JS, Dossett LA. New Persistent Opioid Use Among Patients With Cancer After Curative-Intent Surgery. J Clin Oncol. 2017 Dec 20;35(36):4042-4049. doi: 10.1200/JCO.2017.74.1363. Epub 2017 Oct 19.
- Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
- Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
- Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
- Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
- Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
- Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA; Opioids After Surgery Workgroup. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. doi: 10.1016/j.jamcollsurg.2018.07.659. Epub 2018 Aug 14.
- Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
- Brescia AA, Waljee JF, Hu HM, Englesbe MJ, Brummett CM, Lagisetty PA, Lagisetty KH. Impact of Prescribing on New Persistent Opioid Use After Cardiothoracic Surgery. Ann Thorac Surg. 2019 Oct;108(4):1107-1113. doi: 10.1016/j.athoracsur.2019.06.019. Epub 2019 Aug 22.
- Lee JS, Vu JV, Edelman AL, Gunaseelan V, Brummett CM, Englesbe MJ, Waljee JF. Health Care Spending and New Persistent Opioid Use After Surgery. Ann Surg. 2020 Jul;272(1):99-104. doi: 10.1097/SLA.0000000000003399.
- Babu KM, Brent J, Juurlink DN. Prevention of Opioid Overdose. N Engl J Med. 2019 Jun 6;380(23):2246-2255. doi: 10.1056/NEJMra1807054. No abstract available.
- Vu JV, Howard RA, Gunaseelan V, Brummett CM, Waljee JF, Englesbe MJ. Statewide Implementation of Postoperative Opioid Prescribing Guidelines. N Engl J Med. 2019 Aug 15;381(7):680-682. doi: 10.1056/NEJMc1905045. No abstract available.
- Brown CS, Vu JV, Howard RA, Gunaseelan V, Brummett CM, Waljee J, Englesbe M. Assessment of a quality improvement intervention to decrease opioid prescribing in a regional health system. BMJ Qual Saf. 2021 Mar;30(3):251-259. doi: 10.1136/bmjqs-2020-011295. Epub 2020 Sep 16.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2013
Completamento primario (Effettivo)
31 dicembre 2019
Completamento dello studio (Effettivo)
31 dicembre 2019
Date di iscrizione allo studio
Primo inviato
15 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
15 marzo 2021
Primo Inserito (Effettivo)
18 marzo 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 marzo 2021
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM00119139
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Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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