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RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)

17. juli 2026 opdateret af: Baylor Research Institute

RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.

The goal of this pragmatic randomized clinical trial is to determine whether an Epic-based clinician notification increases initiation of guideline-directed cardio-kidney-metabolic (CKM) therapies in adults with type 2 diabetes and confirmed albuminuria.

The main question it aims to answer is:

• Does an Epic clinician notification improve initiation of guideline-directed CKM therapies compared with usual care?

Researchers will compare an Epic in-basket clinician notification strategy with usual care.

In the intervention arm, the treating clinician will receive an Epic notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing electronic health record (EHR) data. Participants in the usual care arm will receive standard clinical care without notification.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a pragmatic, randomized, EHR-embedded implementation trial designed to evaluate whether an Epic-based clinician notification improves initiation of guideline-directed CKM therapies in adults with type 2 diabetes and confirmed albuminuria.

Despite contemporary guideline recommendations, substantial gaps remain in urine albumin-to-creatinine ratio (UACR) screening, confirmatory testing, and initiation of evidence-based CKM therapies, including renin-angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), non-steroidal mineralocorticoid receptor antagonists (ns-MRA), and glucagon-like peptide-1 receptor agonists (GLP-1RA). Health-system workflows frequently fail to translate identification of albuminuria-associated CKM risk into timely initiation of disease-modifying therapy.

Eligible participants will be randomized in a 1:1 ratio to either usual care or an Epic-based clinician notification strategy.

In the intervention arm, the treating clinician will receive an Epic in-basket message identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. All treatment decisions will remain at the discretion of the treating clinician.

The primary endpoint is initiation of one or more eligible guideline-directed CKM therapies within 3 months of randomization.

This study will provide important implementation data regarding whether low-burden EHR-based clinician notifications can improve evidence-based CKM care in real-world clinical practice settings.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
      • Plano, Texas, Forenede Stater, 75093
        • Baylor Scott and White, Advanced Heart Care
        • Kontakt:
        • Ledende efterforsker:
          • Shahzeb Khan, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  • Adults aged ≥18 years
  • Diagnosis of type 2 diabetes mellitus
  • Receiving outpatient care within Baylor Scott & White Health
  • At least 1 outpatient encounter within the preceding 12 months
  • Confirmed albuminuria (UACR >30 mg/g)
  • Eligible for one or more guideline-directed CKM therapies based on - prespecified clinical criteria and EHR review

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Contraindication or documented intolerance to all eligible guideline-directed CKM therapies
  • Advanced kidney dysfunction below recommended initiation thresholds for SGLT2i or finerenone
  • Hyperkalemia or elevated baseline serum potassium precluding safe therapy initiation
  • Contraindicated drug interactions (e.g., strong CYP3A inhibitors with finerenone)
  • Other guideline- or labeling-based contraindications to therapy initiation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Epic Clinician Notification
Treating clinicians receive an Epic in-basket notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. All treatment decisions remain at the discretion of the treating clinician.
Andet: Epic-Based Clinician Notification
Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.
Aktiv komparator: Usual Care
Participants receive standard clinical care without Epic clinician notification. Treatment decisions, including initiation of guideline-directed CKM therapies, remain at the discretion of the treating clinician.
Andet: Usual Care
Standard clinical care without Epic clinician notification.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy
Tidsramme: 3 months
Proportion of eligible participants newly prescribed one or more guideline-directed cardio-kidney-metabolic (CKM) therapies, including renin-angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), non-steroidal mineralocorticoid receptor antagonists (ns-MRA), or glucagon-like peptide-1 receptor agonists (GLP-1RA) as assessed using electronic health record (EHR) data.
3 months
Therapy-Specific Initiation Rate
Tidsramme: 3 months
Proportion of participants eligible for a specific CKM therapy who were newly prescribed each individual guideline-directed CKM therapy class (RASi, SGLT2i, ns-MRA, or GLP-1RA), as assessed using electronic health record (EHR) data.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Guideline-Directed Therapy Initiation
Tidsramme: 3 months
Time from randomization to initiation of one or more eligible guideline-directed CKM therapies, assessed using electronic health record (EHR) prescribing data.
3 months
Repeat Epic Notification Frequency
Tidsramme: 30 days
Proportion of participants requiring repeat Epic clinician notification due to absence of documented therapy initiation or clinician response within 30 days of the initial notification, as assessed using electronic health record (EHR) data.
30 days
Clinician Reach
Tidsramme: 3 months
Proportion of eligible clinicians who received Epic-based CKM notifications, as assessed using electronic health record (EHR) notification metadata.
3 months
Clinician Response to Epic Notification
Tidsramme: 30 days
Proportion of Epic clinician notifications associated with documented clinician acknowledgment, therapy initiation, or therapy deferral, as assessed using electronic health record (EHR) data.
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baylor Research Institute

Efterforskere

  • Ledende efterforsker: Shahzeb Khan, MD, Baylor Scott and White Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. januar 2028

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 026-355

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual participant data (IPD) underlying the reported study results will be shared, including demographic, clinical, laboratory, prescribing, and implementation-related variables collected through the electronic health record (EHR). A data dictionary and analytic code may also be shared to support interpretation and reproducibility.

IPD-delingstidsramme

Data will become available following publication of the primary study results and will remain available for at least 5 years after publication.

IPD-delingsadgangskriterier

Access will be provided to qualified researchers upon reasonable request following review and approval by the study investigators and Baylor Scott & White Research Institute. Shared data will be deidentified and made available in accordance with institutional policies, applicable regulations, and data use agreements.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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