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.
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Oksana Harasemiw, MSc
- 電話番号：204-632-3541
- メール：oharasemiw@sogh.mb.ca
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3T 2N2
- University of Manitoba
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コンタクト：
- Oksana Harasemiw, MSc
- 電話番号：1-204-632-3541
- メール：oharasemiw@sogh.mb.ca
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite of kidney failure and all-cause mortality
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Attendance at a clinic visit with a nephrologist
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Navdeep Tangri, MD, PhD、University of Manitoba
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HS25871 (H2023:052)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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