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A Difference-In-Differences Analysis of New Persistent Opioid Use After Surgery

15 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

30000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • University of Michigan

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: Retrospective analysis of opioid use after surgery
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states.
Délai: Postoperative days 4 to 180
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.
Postoperative days 4 to 180

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to Indiana and Wisconsin
Délai: Postoperative days 4 to 180
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.
Postoperative days 4 to 180
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).
Délai: Postoperative days 4 to 180
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.
Postoperative days 4 to 180

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Les enquêteurs

  • Chercheur principal: Chad Brummett, MD, University of Michigan

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2013

Achèvement primaire (Réel)

31 décembre 2019

Achèvement de l'étude (Réel)

31 décembre 2019

Dates d'inscription aux études

Première soumission

15 mars 2021

Première soumission répondant aux critères de contrôle qualité

15 mars 2021

Première publication (Réel)

18 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mars 2021

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HUM00119139

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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