Trial de efetividade de implementação inteligente 1 (SMART & SIMPLE)
Estratégias únicas de manutenção e terapia do alívio para ensaios de implementação e eficácia (inteligente e simples)
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 electronic medical record clinical decision support and education implementation strategies (CDS+) to increase adoption of SMART in pediatric primary care. This is the first of two related records.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 - current study) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Chén Kenyon, MD, MSHP
- Número de telefone: 267-426-6339
- E-mail: kenyonc@chop.edu
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Recrutamento
- Children's Hospital of Philadelphia
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Contato:
- Chén Kenyon, MD, MSHP
- Número de telefone: 267-426-6339
- E-mail: kenyonc@chop.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Clinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+). |
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+).
Outros nomes:
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Comparador Ativo: Control
Clinics in Arm 2 will not be exposed to the interventions. |
Clinics in Arm 2 will not be exposed to the interventions. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the Rate of Visit-Level SMART Adoption
Prazo: Assessment of rates from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and the baseline period (Interval 0). 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 0 (baseline; 11 months), Interval 1 (CDS+; 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the Proportion of Patient-Level SMART Sustainment
Prazo: Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and baseline period (Interval 0). 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 0 (baseline; 11 months), Interval 1 (CDS+; 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).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in the Proportion of Clinic-Level SMART Penetration
Prazo: Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and the baseline period (Interval 0). 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 0 (baseline; 11 months), Interval 1 (CDS+; 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23-021702 A
- R01HL173600 (Concessão/Contrato do NIH dos EUA)
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