Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study

Study Overview
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Brief Summary
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This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.

Detailed Description
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Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.

Official Title
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Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Medication reconciliation
* Other: Blood Pressure Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 years and older Patients who have developed moderate to severe AKI in the hospital, defined as: At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate < 60 ml/min/1.73m2 at baseline AKI of any degree whose discharge creatinine does not return to within 50% of baseline. Able to provide signed informed consent Exclusion Criteria: Patients with a history of kidney transplant Patients who, in the opinion of the investigator, are not suitable to participate in the study Unable to obtain written informed consent prisoners or pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active follow-up<br>Participants randomized to the active follow-up arm will have follow-up visits in the AKI follow-up clinic every 4 weeks after discharge for a total of 90 days after discharge | Other: Medication reconciliation<br>* Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.<br>Other: Blood Pressure Management<br>* Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)<br>|
| Active Comparator: Usual follow-up<br>Participants randomized to the usual follow-up arm will be called at home 4 weeks after the baseline visit to collect information on primary and secondary outcomes. | Other: Medication reconciliation<br>* Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.<br>Other: Blood Pressure Management<br>* Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incorrectly prescribed medicines | The number of incorrectly dosed or prescribed medications that are detected or changed | 90 days | 
| Proportion of individuals restarting RAAS inhibitors | Proportion of patients with a class I indication for renin-angiotensin-aldosterone (RAAS) inhibitors who have appropriately re-started RAAS inhibitors within 3 months of discharge. | 90 days | 
| Blood pressure control | Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic. | 90 days | 
| Recovery of kidney function | Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse kidney outcomes | Defined as a composite of death, need for new dialysis, rehospitalization for AKI, recurrent AKI, or a persistent increase in baseline serum creatinine of ≥ 50%. | 90 days |