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- Registre américain des essais cliniques
- Essai clinique NCT02283086
Effects of Performance Feedback on Imaging Use in the Emergency Department
DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013.
SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.
PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and randomized to receive feedback reporting or not.
INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE) beginning January 2013.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Setting and Subjects This IRB-approved and HIPAA-compliant prospective randomized controlled trial was conducted from January 1, 2012 to December 31, 2013 in the ED of an urban Level-I adult trauma center. Imaging CDS was deployed for all CTPE requests throughout the study period as previously reported. Ordering providers could ignore the evidence presented in CDS and proceed with CTPE requests deviating from evidence-based guidelines without interference. The investigators included all attending emergency physicians and, prior to randomization, stratified them into quartiles by 2012 CTPE use. Physicians were randomized by quartile into two groups using a random number generator: the intervention group received individualized feedback reports on CTPE adherence to EBG, use (defined as number of CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE), and the control group did not.
Data Collection Use of CTPEs for each physician was calculated using the number of completed CTPE examinations and the total number of patients seen during the quarter. Yield of CTPEs for acute PE was determined using a previously validated natural language processing tool and reported as a percentage of total CTPEs completed. Adherence to EBG was determined by applying the Wells Criteria and reviewing the serum D-dimer levels (if obtained). The discrete criteria making up the Wells Criteria were prospectively documented in the investigators computerized order entry (CPOE) system at the time of order entry, as previously reported.
In order to determine whether any differences observed in guideline adherence were the result of "gaming" (erroneous data entry to either avoid potentially onerous CDS interactions or to enhancing the physician's apparent performance on feedback reports) the investigators performed manual chart reviews of 100 randomly chosen charts from each of the two groups. These chart reviews were performed by an attending physician to assess concordance between adherence to EBG calculated from the CDS data, and adherence to EBG calculated from data documented in the ED visit clinical note. The sample size was determined using a baseline concordance of 90% as previously reported, and chosen to detect a difference in concordance of 15% between groups with a power of 80% and an alpha error rate of 5%. Demographic data (including gender and both age and years since residency training as measured at the beginning of the study period) was also captured for all the attending physicians in the study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All attending physicians in the emergency department
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Contrôler
|
|
Expérimental: Intervention
The intervention consisted of quarterly performance feedback reports sent via e-mail.
|
The performance feedback reports displayed both individual physicians' statistics as well as their performance compared to anonymized results for the entire group of emergency physicians.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adherence to Evidence-Based Guidelines
Délai: 2 years
|
Percentage of CTPE orders that adhere to evidence-based guidelines for the ordering of CTs for PE
|
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Use of Computed Tomography for Pulmonary Embolism
Délai: 2 years
|
#CTPEs/1,000 ED visits for each physician
|
2 years
|
Yield of Computed Tomography for Pulmonary Embolism
Délai: 2 years
|
Percentage of CTPE orders that are positive for acute PE
|
2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ramin Khorasani, MD, Brigham and Women's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2009-P001587
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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