Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety-Net)
Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)
The objective of this initiative is to develop and evaluate a risk-based, provincial public health screening program for chronic kidney disease (CKD) that provides proactive care for adults at high-risk of kidney failure who have not previously been referred to a nephrologist, through risk stratification, triage, education, and follow-up.
Overall, we aim to demonstrate that an integrated risk-based provincial public health screening program for CKD is feasible, and improves identification of high-risk individuals, subsequently creating a model of care that can be adopted by other jurisdictions.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
A Parallel Group Randomized Controlled Trial will be conducted implementing our previously developed laboratory-based risk prediction models into a new provincial CKD surveillance system. Using administrative data through the Manitoba Centre for Health Policy (MCHP), we will identify all high-risk adults with CKD in Manitoba who had appropriate laboratory testing for CKD (i.e. at least 2 eGFR tests) completed in the 2 most recent years of available data, and who subsequently met nephrology referral criteria, but were never referred to a nephrologist. All individuals identified will be randomized to either: (1) receive a letter describing their results and an invitation for a consult with a clinical assistant and a nephrologist at Seven Oaks General Hospital, or (2) usual care (i.e. no letter and referral to nephrology based on their primary care physician/circle of care).
The program will support the integration of risk-based care at a population-level, in turn providing opportunities that will prompt changes in further investigation, treatment, referral for education, and inform a personalized medicine approach for patient-provider discussions regarding prognosis.
All outcomes will be collected using provincial administrative databases accessed through the Manitoba Centre for Health Policy (MCHP).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Oksana Harasemiw, MSc
- Número de telefone: 204-632-3541
- E-mail: oharasemiw@sogh.mb.ca
Locais de estudo
-
-
Manitoba
-
Winnipeg, Manitoba, Canadá, R3T 2N2
- University of Manitoba
-
Contato:
- Oksana Harasemiw, MSc
- Número de telefone: 1-204-632-3541
- E-mail: oharasemiw@sogh.mb.ca
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age > 18 years old
- Resident of Manitoba / has Manitoba Health coverage
- Either:
- 2 eGFR <15 mL/min/1.73m2 tests within a 2-year timeframe or
- A greater than 10% 2-year kidney failure risk (at 2 separate timepoints within a 2-year timeframe) - using the 4-variable or 3-variable 2-year Kidney Failure Risk Equation (KFRE)
Exclusion Criteria:
- A previous billing claim from a nephrologist
- Receiving palliative care within 3 months of randomization
- Previous history of dialysis and/or kidney transplantation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Arm
Individuals randomized to the intervention group will receive a letter from MCHP.
A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation.
Individuals who respond to the letter by contacting the study team will be scheduled for an initial clinic appointment with a Clinical Assistant/Nephrologist, and will begin receiving routine clinical care thereafter, as per local clinical guidelines.
|
Individuals randomized to the intervention group will received a direct mailing consisting of:
|
|
Sem intervenção: Control Arm
Individuals randomized to the control group will continue receiving usual care without any intervention from the study team.
Their outcomes will be ascertained using de-identified administrative data.
If the trial is successful, indivdiuals in the control group will be contacted for follow-up with a nephrologist in the same manner (i.e. through a mailout letter) as the intervention group was.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Composite of kidney failure and all-cause mortality
Prazo: within 12 months of letter mailout
|
Kidney failure defined as dialysis, kidney transplantation.
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Attendance at a clinic visit with a nephrologist
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
Individual components of the composite primary outcome
Prazo: within 12 months of letter mailout
|
Kidney failure (dialysis and/or transplantation) and all-cause mortality. Collected using provincial administrative databases accessed through the MCHP o All-cause mortality |
within 12 months of letter mailout
|
|
Alll-cause hospitalizations and emergency room visits
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
Major adverse cardiac events
Prazo: within 12 months of letter mailout
|
Major adverse cardiac events (MACE+, defined as myocardial infarction (MI), ischemic stroke, incident heart failure (a new heart failure diagnosis in a patient without evidence of heart failure at baseline), heart failure admission (an inpatient admission with a concurrent diagnosis of heart failure in patients with a history of heart failure), or cardiovascular death (death within the same or next calendar month as discharge from an inpatient hospital stay involving a diagnosis code for heart failure, stroke, or MI)).
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
eGFR (mL/min/1.73 m²)
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
Urine albumin-to-creatinine ratio (mg/mmol)
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
|
2-year Kidney Failure Risk Equation Score
Prazo: within 12 months of letter mailout
|
Collected using provincial administrative databases accessed through the MCHP
|
within 12 months of letter mailout
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Navdeep Tangri, MD, PhD, University of Manitoba
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Processos Patológicos
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doença crônica
- Atributos da doença
- Insuficiência renal
- Condições Patológicas, Sinais e Sintomas
- Doenças renais
- Insuficiência Renal Crônica
Outros números de identificação do estudo
- HS25871 (H2023:052)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .