- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02585557
Heart Health NOW (Previously Known as FAST PACE NC) (HHN)
Heart Health NOW (Previously Known as Facilitation, Spread, and Translation of Patient-Centered Evidence in North Carolina Practices)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.
This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.
A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Primary care practice in North Carolina with 10 or fewer providers in a single location
- must have implemented an EHR and either be connected to or have agreed to connect to the HIE.
Exclusion Criteria:
- practices with more than 10 providers in a single location
- practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
- practices without an EHR
- practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach
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 croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Cluster A
50 practices randomly assigned to start intervention at month 9. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Expérimental: Cluster B
50 practices randomly assigned to start intervention at month 11.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Expérimental: Cluster C
50 practices randomly assigned to start intervention at month 12. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Expérimental: Cluster D
50 practices randomly assigned to start intervention at month 14.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Expérimental: Cluster E
50 practices randomly assigned to start intervention at month 16.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk
Délai: 18 months
|
By comparing EHR data at baseline and post-intervention, determine whether practice support resulted in discernible reduction in CVD risk.
|
18 months
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Sam Cykert, MD, UNC Chapel Hill
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- 15-0479
- 1R18HS023912-01 (Subvention/contrat AHRQ des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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 .
Essais cliniques sur Primary Care Practice Support
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