Acute Kidney Injury
Conditions
Brief summary
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.
Interventions
BEHAVIORALAcute 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.
BEHAVIORALUsual Care
Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-Free Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospital readmissions or acute care contact or death | 90-days, 180-days, 1 year | Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death |
| Death | 90-days, 180-days, 1-year | Death after discharge |
| AKI recurrence | 90 days, 180 days, 1 year | Total number of patients to experience a recurrence of acute kidney injury after discharge. |
| Major Adverse Kidney Event | 90-, 180- days | Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline |
| Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline | 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. |
| Chronic kidney disease (CKD) | 90 days, 180 days, 1 year | Total number of patients with new or worsening chronic kidney disease (CKD) post discharge |
| End-stage kidney disease (ESKD) | 90 days, 180 days, 1 year | Total number of patients with end-stage kidney disease (ESKD) post discharge |
| Kidney transplantation | 90 days, 180 days, 1 year | Total number of patients that require kidney transplantation post discharge |
| Major adverse cardiovascular event | 90-days, 180-days, 1 year | Incidence of major adverse cardiovascular event |
| Provider and laboratory follow-up | 30-days, 90-days, 180-days | Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up |
| Post-discharge serum creatinine evaluation | time to first, 30-days, 90-days, 180-days | Assessment of serum creatinine in the post-discharge interval |
| Post-discharge urine protein evaluation | time to first, 30-days, 90-days, 180-days | Assessment of urine protein in the post-discharge interval |
| Primary care follow-up | time to first, 30-days, 90-days, 180-days | Occurrence of a completed primary care encounter after discharge |
| Nephrology follow-up | time to first, 30-days, 90-days, 180-days | Occurrence of completed nephrology follow-up during the post-discharge interval |
| Pharmacist follow-up | time to first, 30-days, 90-days, 180-days | Occurrence of a completed pharmacist encounter in the post-discharge interval |
| Guideline concordant care | 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. |
| Engaged in remote monitoring program (RPM) program | 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) |
Countries
United States
Contacts
CONTACTMitchell C. Strand
PRINCIPAL_INVESTIGATORErin F. Barreto, Pharm.D., Ph.D.
Mayo Clinic
Outcome results
None listed