Essai de mise en œuvre de mise en œuvre intelligente 2 (SMART SIMPLE)
Stratégies de thérapie de maintenance et de releveur unique pour la mise en œuvre et l'efficacité (intelligemment et simple)
While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adoption of SMART has not been rigorously assessed. This study will test population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for Steps 3 and 4 (moderate/severe) asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chén Kenyon, MD, MSHP
- Numéro de téléphone: 267-426-6339
- E-mail: kenyonc@chop.edu
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Recrutement
- Children's Hospital of Philadelphia
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Contact:
- Chén Kenyon, MD, MSHP
- Numéro de téléphone: 267-426-6339
- E-mail: kenyonc@chop.edu
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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
Clinic Inclusion Criteria:
- The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC).
- The clinic agrees to participate in SMART & SIMPLE study.
Patient Inclusion Criteria:
- Ages 5-18 years;
- Has clinic visit at participating practice during study interval (sick, well, or follow-up)
- Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year;
- Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months)
Clinic Exclusion Criteria:
- The clinic is not willing to participate in SMART & SIMPLE study interventions.
Patient Exclusion Criteria:
- Transferred clinics or left the CHOP Pediatric Care Network.
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 parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Control
Clinics in Arm 2 will not be exposed to the interventions. |
Clinics in Arm 2 will not be exposed to the interventions. |
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Expérimental: Intervention
Clinics in Arm 1 will receive the interventions in Intervals 1 and 2. Interval 1 intervention: clinical decision support and education (CDS+). Interval 2 interventions: CDS and education (CDS+) and population health management (community health worker and nurse care manager) (PHM). |
In Interval 1, intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+). In Interval 2, intervention clinics will have CDS+ and population health management (PHM) strategies, including an asthma community health worker and an asthma nurse care manager.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Rate of Visit-Level SMART Adoption
Délai: Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
|
The difference in the rate of SMART prescribing (initiation) among eligible primary care visits (i.e., when a child is eligible to start SMART) where SMART is first prescribed (initiated) comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated). |
Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in the Proportion of Patient-Level SMART Sustainment
Délai: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
|
The difference in the proportion of patients who are prescribed (initiated) SMART who continue on SMART for at least 6 months comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Sustainment is patient-level. The denominator represents patients who are prescribed (initiated) SMART, and the numerator represents patients who continue on SMART for at least 6 months. |
Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Proportion of Clinic-Level SMART Penetration
Délai: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
|
The difference in the clinic-level proportion of SMART-eligible patients who are prescribed (initiated) and not subsequently discontinued from SMART by the end of the interval comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Penetration is clinic-level. The denominator represents patients who are SMART-eligible in each interval, and the numerator represents patients who are prescribed (initiated) during the interval and still on SMART at the end of the interval. |
Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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Collaborateurs et enquêteurs
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Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
- Prestation de soins de santé
- Qualité des soins de santé, accès et évaluation
- Facteurs socioéconomiques
- Caractéristiques de la population
- Technologie, industrie et agriculture
- Technologie
- SIDA audiovisuelle
- Technologie éducative
- Télévision
- Enregistrement vidéo
- Dispositifs de stockage optiques
- Statut éducatif
- Disques compacts
- Gestion de la santé de la population
Autres numéros d'identification d'étude
- 23-021702 B
- R01HL173600 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
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