- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00581711
Improving Otitis Media Care With Clinical Decision Support (OMHIT)
Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.
Objectives
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes OM care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians. The specific aims are:
Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.
Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).
Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.
Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- The Children's Hospital of Philadelphia
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.
Exclusion Criteria:
- There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Contrôle
Soins habituels
|
|
Expérimental: HIT Intervention without feedback
3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support
|
A combination of training, an otitis media episode grouper, and clinical decision support.
|
Expérimental: HIT Intervention with feedback
4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback.
|
A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
|
Expérimental: Feedback only
1 part intervention: Physician Feedback
|
Provision of feedback on otitis media quality indicators
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Quality of otitis media care.
Délai: 18 Months
|
18 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Clinician adoption of intervention and Resource Utilization
Délai: 18 months
|
18 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher B Forrest, MD, PhD, Children's Hospital of Philadelphia
Publications et liens utiles
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2007-10-5555
- 1R18HS017042-01 (Subvention/contrat AHRQ des États-Unis)
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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