Designing and Implementing a Safety Net Surveillance Program for High Risk CKD

Официальное название

Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Letter to participants
  Individuals randomized to the intervention group will received a direct mailing consisting of: 1. A letter explaining the purpose of the study and the benefits of screening for CKD, with contact information for the study team at Seven Oaks General Hospital / Chronic Disease Innovation Centre, who they may contact to receive further information and to book a follow-up appointment with a Clinical Assistant/Nephrologist 2. A brief fact sheet on CKD A follow-up reminder letter will be sent at 3 mon

Первичные конечные точки

• Composite of kidney failure and all-cause mortality [Срок оценки: within 12 months of letter mailout]

Вторичные конечные точки (6)

• Attendance at a clinic visit with a nephrologist [Срок оценки: within 12 months of letter mailout]
• Individual components of the composite primary outcome [Срок оценки: within 12 months of letter mailout]
• Alll-cause hospitalizations and emergency room visits [Срок оценки: within 12 months of letter mailout]
• Major adverse cardiac events [Срок оценки: within 12 months of letter mailout]
• eGFR, urine ACR, KFRE at follow-up [Срок оценки: 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 [Срок оценки: within 12 months of letter mailout]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• A previous billing claim from a nephrologist
• Receiving palliative care within 3 months of randomization
• Previous history of dialysis and/or kidney transplantation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Канада · 1 центр

• University of Manitoba — Winnipeg

Идентификаторы

NCT: NCT07724288 · HS25871 (H2023:052)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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