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- Ensaio Clínico NCT03404999
Clinical-Decision Support to Improve Hypertension Care in Primary Care
Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care
Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.
The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:
IDENTIFY AND DOCUMENT
- when a child's blood pressure is elevated, and
- whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN
ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:
- laboratories and studies per 2017 updated guidelines
- follow-up interval in primary care
- referral to nephrology, when indicated, and
- patient education on diet/lifestyle modification.
The investigators are working on improving this system further with addition of orders for:
- referral for sleep-apnea testing and treatment, when indicated, and
- blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.
OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for Providers: Pediatric primary care providers practicing at participating clinics that have agreed to have the decision-support system implemented.
Exclusion Criteria for Providers:
- Lack of electronic health record
Inclusion Criteria for Children:
- Measured systolic or diastolic blood pressure >=90th % for age/sex, or
- >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)
Exclusion Criteria for Children:
- Diagnosis/visit for high blood pressure or hypertension in past 2 years
- Taking anti-hypertensive medication
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: clinical decision support activated
TWO MED ASSIST ALERTS
ONE PROVIDER ALERT
TAILORED ORDERSETS
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Decision support system (see description of hypertension decision support system alerts and order sets for details)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
High blood pressure addressed
Prazo: 4-month time series analysis
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Proportion of patients with high blood pressure addressed post decision-support implementation (vs.
pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension.
We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice.
In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires.
In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.
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4-month time series analysis
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- STU 052015-029
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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