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L'essai clinique NCT05986695 (Nudge) pour Insuffisance cardiaque est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Informational Nudge to Improve Heart Failure Prescribing
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L'étude clinique NCT05986695 (Nudge) est un essai interventionnel pour Insuffisance cardiaque. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 9 juin 2023 et vise à recruter 89 participants. Dirigé par VA Office of Research and Development, l'essai devrait être terminé d'ici le 30 septembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 20 juillet 2025.
Résumé succinct
This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and prevents HF hospitalizations. The investigators will compare the effect of clinician directed nudges as strategies to improve the health of Veterans with HF.
Description détaillée
This study addresses a critical gap in quality of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid receptor antagonists, both medications that save lives and prevents HF hospitalizations. The investigators will combine insights from behavioral science and quality improvement science to create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will compare the effect of these two nudge strategies alone and in combination compared to usual care. This project will develop simple, scalable, and low-cost strategies to improve the health of Veterans with HF.
Titre officiel
Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing
Conditions
Insuffisance cardiaqueAutres identifiants de l'essai
- Nudge
- PPO 22-091
Numéro NCT
Date de début (réel)
2023-06-09
Dernière mise à jour publiée
2025-07-20
Date de fin (estimée)
2025-09-30
Inscription (estimée)
89
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Mots clés
Sodium-Glucose Transporter 2 Inhibitors
Mineralocorticoid Receptor Antagonists
Economics, Behavioral
feedback
medical audit
Mineralocorticoid Receptor Antagonists
Economics, Behavioral
feedback
medical audit
Objectif principal
Recherche sur les services de santé
Plan d'attribution
Randomisé
Modèle d'intervention
Factoriel
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifPeer Comparison Report Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance. | Peer Comparison Report Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. |
Comparateur actifAlert Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week. | Alerte Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note |
Comparateur actifAlert and Peer Comparison The combined alert and peer comparison arm will receive both interventions. | Alerte Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note Peer Comparison Report Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. |
Aucune interventionControl No alert or peer comparison | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Effectiveness | The primary effectiveness outcome is the proportion of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). | 30 days |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Reach-Clinician | Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison. | 6 months |
Incidence of Treatment Emergent Adverse Events | The investigators will measure safety as the number of discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions. | 30 days |
Implementation-Acceptability | Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. Likert Scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Reach-Patient | At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients. | 6 months |
Reach-Comparison of Strategies | the investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy. | 6 months |
Implementation-Appropriateness | Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Implementation-Feasibility | Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting
- Clinicians who are in training status (resident, fellow) will be excluded.
VA Office of Research and DevelopmentUniversité d'État de l'ArizonaAucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Arizona
Southern Arizona VA Health Care System, Tucson, AZ, Tucson, Arizona, 85723-0001, United States