Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial
ConditionAcute Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Adults ≥18 years old
Disqualifiers
Care exclusively for pediatric patients (<18 years)
Care exclusively for patients on palliative care
Patient subjects
Discharged to hospice care
Trial design
Design model
Parallel
Treatments tested in this trial
Acute Kidney Injury in Care Transitions (ACT)
BehavioralClinicians 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.
Usual Care
BehavioralPhysicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.
Treatment groups
2,260 Participants
are divided into 2 treatment groupsGroup A: Acute Kidney Injury in Care Transitions (ACT) InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hospital-Free Days
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.
Time frame
90 days, 180 days, 1 yearSecondary outcomes
1
Unplanned hospital readmissions or acute care contact or death
Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death
Time frame
90-days, 180-days, 1 year2
Death
Death after discharge
Time frame
90-days, 180-days, 1-year3
AKI recurrence
Total number of patients to experience a recurrence of acute kidney injury after discharge.
Time frame
90 days, 180 days, 1 year4
Major Adverse Kidney Event
Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline
Time frame
90-, 180- daysOther outcomes
1
Proteinuria
Binary classification of proteinuria in patients with laboratory data available from the scheduled follow-up time
Time frame
90 days, 180 days, 1 year2
Excess days in acute care
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.
Time frame
90 days, 180 days, 1 year3
Hierarchical composite outcome
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
Time frame
90 days, 180 days, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov