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

12. august 2026 oppdatert av: Navdeep Tangri, University of Manitoba

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

972

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • University of Manitoba
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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 months in individuals that do not respond to the initial invitation.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite of kidney failure and all-cause mortality
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Attendance at a clinic visit with a nephrologist
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Manitoba

Samarbeidspartnere

Seven Oaks Hospital Chronic Disease Innovation Centre
Can-SOLVE CKD Network

Etterforskere

  • Hovedetterforsker: Navdeep Tangri, MD, PhD, University of Manitoba

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HS25871 (H2023:052)

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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