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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Oksana Harasemiw, MSc
- 전화번호: 204-632-3541
- 이메일: oharasemiw@sogh.mb.ca
연구 장소
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3T 2N2
- University of Manitoba
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연락하다:
- Oksana Harasemiw, MSc
- 전화번호: 1-204-632-3541
- 이메일: oharasemiw@sogh.mb.ca
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite of kidney failure and all-cause mortality
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Attendance at a clinic visit with a nephrologist
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Navdeep Tangri, MD, PhD, University of Manitoba
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- HS25871 (H2023:052)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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