- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.
This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.
This is a quality improvement project with two primary objectives:
- Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing
- Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns
There are two corresponding specific aims:
- Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:
- Number of opioid prescriptions per hundred patients seen
- Percentage of total prescriptions written that are opioids
- Mean or median quantity of pills dispensed per opioid prescription
- Number of prescriptions for long-acting opioid formulations
- Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group
This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Massachusetts
-
Clinton, Massachusetts, Verenigde Staten
- UMass Clinton Hospital
-
Marlborough, Massachusetts, Verenigde Staten
- UMass Memorial Marlborough Hospital
-
Worcester, Massachusetts, Verenigde Staten
- UMass Memorial Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).
- Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines
- Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines
Exclusion Criteria:
- None
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
|
|
|
Experimenteel: Intervention
Providers who are subject to routine clinical practice guideline implementation AND receive provider's own individual prescribing data profile intervention ("Individual prescribing data profile and self-assessment")
|
Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices.
Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers.
All peer data are de-identified.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in number of opioid prescriptions per hundred patients seen
Tijdsspanne: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in percentage of total prescriptions written that are opioids
Tijdsspanne: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in median quantity of pills dispensed per opioid prescription
Tijdsspanne: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
|
Change in number of prescriptions for long-acting opioid formulations
Tijdsspanne: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
Tijdsspanne: Once, at time of enrollment
|
The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for percentage of total prescriptions written that are opioids
Tijdsspanne: Once, at time of enrollment
|
The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for median quantity of pills dispensed per opioid prescription
Tijdsspanne: Once, at time of enrollment
|
The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers
|
Once, at time of enrollment
|
|
Self-assessment of decile for number of prescriptions for long-acting opioid formulations
Tijdsspanne: Once, at time of enrollment
|
The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers
|
Once, at time of enrollment
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sean Michael, MD, UMass Memorial Health Care
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H00009241
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .