- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Clinton, Massachusetts, Vereinigte Staaten
- UMass Clinton Hospital
-
Marlborough, Massachusetts, Vereinigte Staaten
- UMass Memorial Marlborough Hospital
-
Worcester, Massachusetts, Vereinigte Staaten
- UMass Memorial Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
|
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in number of opioid prescriptions per hundred patients seen
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in percentage of total prescriptions written that are opioids
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Sean Michael, MD, UMass Memorial Health Care
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H00009241
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Bereitstellung von Gesundheitsleistungen
-
Queens College, The City University of New YorkRekrutierungVeröffentlichung von Artikeln, die beim American Journal of Public Health eingereicht wurdenVereinigte Staaten
-
Stuby LoricUniversity Hospital, Geneva; Geneve TEAM AmbulancesNoch keine RekrutierungAusbildung | Fernunterricht-Online-Lernen | Klinische Kompetenz | Schlaganfallskala der National Institutes of Health | Modifizierte Rankin-Skala | SchlaganfallbewertungSchweiz
-
Hospital Central Sur de Alta EspecialidadUnbekanntStreicheln | Schlaganfallskala der National Institutes of Health | Serum mit hochempfindlichem C-reaktivem ProteinMexiko
-
Huizhou Municipal Central HospitalAbgeschlossenSchlaganfallskala der National Institutes of Health | Chronischer Verschluss der mittleren Hirnarterie | Stenting-Behandlung | Modifizierte Rankin-SkalaChina
-
University of California, San FranciscoUniversity of California, DavisNoch keine RekrutierungTeilnehmerinnen müssen Frauen im Alter von 25 Jahren oder älter sein | Teilnehmer sollten keine selbstberichtete Vorgeschichte von Herzerkrankungen oder Schlaganfall haben | Teilnehmer sollten keine unheilbare Krankheit oder diagnostizierte kognitive Beeinträchtigung, einschließlich... und andere BedingungenVereinigte Staaten
Klinische Studien zur Individual prescribing data profile and self-assessment
-
University of ArkansasAbgeschlossenPsychische GesundheitVereinigte Staaten