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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Oksana Harasemiw, MSc
- Número de teléfono: 204-632-3541
- Correo electrónico: oharasemiw@sogh.mb.ca
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3T 2N2
- University of Manitoba
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Contacto:
- Oksana Harasemiw, MSc
- Número de teléfono: 1-204-632-3541
- Correo electrónico: oharasemiw@sogh.mb.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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Individuals randomized to the intervention group will received a direct mailing consisting of:
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite of kidney failure and all-cause mortality
Periodo de tiempo: within 12 months of letter mailout
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Kidney failure defined as dialysis, kidney transplantation.
Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attendance at a clinic visit with a nephrologist
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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Individual components of the composite primary outcome
Periodo de tiempo: within 12 months of letter mailout
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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
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Alll-cause hospitalizations and emergency room visits
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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Major adverse cardiac events
Periodo de tiempo: within 12 months of letter mailout
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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
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within 12 months of letter mailout
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The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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eGFR (mL/min/1.73 m²)
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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Urine albumin-to-creatinine ratio (mg/mmol)
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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2-year Kidney Failure Risk Equation Score
Periodo de tiempo: within 12 months of letter mailout
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Collected using provincial administrative databases accessed through the MCHP
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within 12 months of letter mailout
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Navdeep Tangri, MD, PhD, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Renales
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- HS25871 (H2023:052)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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