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Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial (ACT)

19. juni 2026 opdateret af: Erin Barreto, Mayo Clinic
The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2260

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
    • Minnesota
      • Mankato, Minnesota, Forenede Stater, 56001
        • Ikke rekrutterer endnu
        • Mayo Clinic Health System-Mankato
        • Kontakt:
          • Mitchell C. Strand
          • Telefonnummer: 507-293-0952
        • Ledende efterforsker:
          • Jing Miao, M.D., Ph.D.
      • Rochester, Minnesota, Forenede Stater, 55905
        • Rekruttering
        • Mayo Clinic in Rochester
        • Kontakt:
          • Mitchell C. Strand
          • Telefonnummer: 507-293-0952
        • Ledende efterforsker:
          • Erin F. Barreto, Pharm.D., Ph.D.
    • Wisconsin
      • Eau Claire, Wisconsin, Forenede Stater, 54703
        • Ikke rekrutterer endnu
        • Mayo Clinic Health System-Eau Claire Clinic
        • Kontakt:
          • Mitchell C. Strand
          • Telefonnummer: 507-293-0952
        • Ledende efterforsker:
          • Suhail B Shuja, M.D.

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:

  • Clinician subjects

    • Hospital clinicians including physicians and advanced practice providers employed by Mayo Clinic and practicing at one of the four study sites
    • Provide care for hospitalized patients with stage 2 or stage 3 acute kidney injury (AKI) who are expected to be discharged home and are not receiving dialysis

  • Patient subjects:

    • Adults ≥18 years old
    • Meet KDIGO consensus criteria for stage 2 (moderate) or 3 (severe) AKI
    • Residence within the study catchment area (southern Minnesota, northern Iowa, or western Wisconsin)

Exclusion Criteria:

  • Clinician subjects: Physicians and advanced practice providers who:

    • Care exclusively for pediatric patients (<18 years)
    • Care exclusively for patients on palliative care

  • Patient subjects

    • Discharged to hospice care
    • Require outpatient dialysis at discharge
    • Are admitted from or expected to be discharged to a skilled nursing facility
    • Dementia Diagnosis
    • Have undergone solid organ transplant within the past 100 days
    • Decline authorization for use of their medical records for research

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acute Kidney Injury in Care Transitions (ACT) Intervention
Physicians and nurse practitioners randomized to the ACT intervention group will be provided access to augmented kidney care support for acute kidney injury patients prior to hospital discharge, individualized according to post-discharge risk.
Adfærdsmæssigt: Acute Kidney Injury in Care Transitions (ACT)
Clinicians will assign risk-individualized kidney health care prior to hospital discharge for acute kidney injury survivors. Low risk acute kidney injury survivors will receive education prior to hospital discharge, moderate risk acute kidney injury survivors will receive a referral to primary care for laboratory and clinical follow-up within approximately 14-days including a medication review by a pharmacist, and high risk acute kidney injury survivors will be referred to nephrologist-directed care including remote monitoring program (RPM) where available and aligned with the patients goals/values/preferences for up to 90 days after discharge for the highest risk patients.
Aktiv komparator: Usual Care
Physicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge.
Adfærdsmæssigt: Usual Care
Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital-Free Days
Tidsramme: 90 days, 180 days, 1 year
Hospital-free days is defined as the total number of days a patient is alive and out of the hospital within the specified time frame.
90 days, 180 days, 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Unplanned hospital readmissions or acute care contact or death
Tidsramme: 90-days, 180-days, 1 year
Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death
90-days, 180-days, 1 year
Death
Tidsramme: 90-days, 180-days, 1-year
Death after discharge
90-days, 180-days, 1-year
AKI recurrence
Tidsramme: 90 days, 180 days, 1 year
Total number of patients to experience a recurrence of acute kidney injury after discharge.
90 days, 180 days, 1 year
Major Adverse Kidney Event
Tidsramme: 90-, 180- days
Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline
90-, 180- days
Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline
Tidsramme: 90 days, 180 days, 1 year
eGFRcreatinine will be estimated from available serum creatinines checked in routine clinical practice at the study time points, and absolute and relative change in eGFR in milliliters per minute per 1.73m2 will be determined.
90 days, 180 days, 1 year
Chronic kidney disease (CKD)
Tidsramme: 90 days, 180 days, 1 year
Total number of patients with new or worsening chronic kidney disease (CKD) post discharge
90 days, 180 days, 1 year
End-stage kidney disease (ESKD)
Tidsramme: 90 days, 180 days, 1 year
Total number of patients with end-stage kidney disease (ESKD) post discharge
90 days, 180 days, 1 year
Kidney transplantation
Tidsramme: 90 days, 180 days, 1 year
Total number of patients that require kidney transplantation post discharge
90 days, 180 days, 1 year
Major adverse cardiovascular event
Tidsramme: 90-days, 180-days, 1 year
Incidence of major adverse cardiovascular event
90-days, 180-days, 1 year
Provider and laboratory follow-up
Tidsramme: 30-days, 90-days, 180-days
Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up
30-days, 90-days, 180-days
Post-discharge serum creatinine evaluation
Tidsramme: time to first, 30-days, 90-days, 180-days
Assessment of serum creatinine in the post-discharge interval
time to first, 30-days, 90-days, 180-days
Post-discharge urine protein evaluation
Tidsramme: time to first, 30-days, 90-days, 180-days
Assessment of urine protein in the post-discharge interval
time to first, 30-days, 90-days, 180-days
Primary care follow-up
Tidsramme: time to first, 30-days, 90-days, 180-days
Occurrence of a completed primary care encounter after discharge
time to first, 30-days, 90-days, 180-days
Nephrology follow-up
Tidsramme: time to first, 30-days, 90-days, 180-days
Occurrence of completed nephrology follow-up during the post-discharge interval
time to first, 30-days, 90-days, 180-days
Pharmacist follow-up
Tidsramme: time to first, 30-days, 90-days, 180-days
Occurrence of a completed pharmacist encounter in the post-discharge interval
time to first, 30-days, 90-days, 180-days
Guideline concordant care
Tidsramme: 90 days, 180 days, 1 year
Occurrence of provider and laboratory and initiation of renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, or glucagon-like peptide-1 agonists in CKD.
90 days, 180 days, 1 year
Engaged in remote monitoring program (RPM) program
Tidsramme: 30 days, 90 days
Total number of patients who submitted one or more sets of vitals/symptoms through the supplied technology or completed one of the scheduled laboratory assessments as part of the remote monitoring program (RPM)
30 days, 90 days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proteinuria
Tidsramme: 90 days, 180 days, 1 year
Binary classification of proteinuria in patients with laboratory data available from the scheduled follow-up time
90 days, 180 days, 1 year
Excess days in acute care
Tidsramme: 90 days, 180 days, 1 year
Total days a patient spends in any acute care setting in the time interval after discharge, compared to what is expected for similar patients. Includes unplanned readmissions, observation stays, and emergency department visits.
90 days, 180 days, 1 year
Hierarchical composite outcome
Tidsramme: 90 days, 180 days, 1 year
  1. Death (y/n)
  2. KRT initiation after discharge (y/n)
  3. Hospital-free days
  4. Unplanned ED/outpatient visit (y/n)
  5. Change in eGFR
90 days, 180 days, 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Mayo Clinic

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Erin F. Barreto, Pharm.D., Ph.D., Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

16. april 2026

Primær færdiggørelse (Anslået)

31. marts 2030

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-009970
  • 1R01DK145433-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.

IPD-delingstidsramme

5 years post primary completion date

IPD-delingsadgangskriterier

Data will be made available to researchers whose research proposal is approved by the principal investigator in addition to approval by the researcher's local site ethics review committee (such as an IRB) and an executed data use agreement.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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