EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. The aim of this trial is to develop, based on a conceptual model of the prescribing process, a set of potential intervention components (EHR-nudges) to promote and support AHA/ACC guideline-concordant statin prescribing. A user-centered design process will be employed. EHR audit log data will be used to identify technical workflows of current provider prescribing patterns. Provider- and patient-directed default, peer comparison, and salient messaging nudges will be developed (5 total). Patient-directed nudges will encourage patients to prompt their providers to prescribe guideline-concordant statins.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nicole Redfern
- Numéro de téléphone: 646-501-2501
- E-mail: Nicole.Redfern@nyulangone.org
Lieux d'étude
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New York
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New York, New York, États-Unis, 10016
- NYU Langone Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Providers:
1. Medical doctor, nurse practitioner, and physician assistants practicing at any NYULH Internal or Family Medicine practice.
Patients:
- Age 40-75 years old
- Had a previous visit in the past 12 months with a provider at any NYULH Internal or Family Medicine practice.
- Had blood pressure documented in the last 12 months
- Had LDL results completed in the last 12 months
- Has either a diagnosis of cardiovascular disease, LDL > 190, or ASCVD risk score ≥ 20%
Exclusion Criteria:
Providers - N/A
Patients:
- Pregnant
- Has allergy or contraindication to statin
- Already taking a high-intensity statin
- Has diagnosis of dementia
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 factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Provider
Providers will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
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Aucune intervention: Control
Providers randomized to this arm will receive no EHR nudges. |
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Expérimental: Patient
Patients will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period
Délai: Month 18
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Month 18
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Safiya Richardson, MD, MPH, NYU Langone Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23-01349
- 1R01HL171292-01 (Subvention/contrat des NIH 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
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Nicole.Redfern@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Critères d'accès au partage IPD
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Nicole.Redfern@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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