Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 11, 2023
Date Accepted: Apr 24, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comprehensive Acute Kidney Injury Survivor Care: A Protocol for the Randomized ACT Pilot Trial
ABSTRACT
Background:
Innovative care models are needed to address gaps in kidney care follow-up among acute kidney injury (AKI) survivors. We developed the multidisciplinary AKI in Care Transitions (ACT) Program, which embeds post-AKI care in patients’ primary care clinic.
Objective:
The objective of this pilot randomized pilot trial is to test the feasibility and acceptability of the ACT Program and study protocol, including recruitment and retention, procedures, and outcome measures.
Methods:
The study will be conducted at Mayo Clinic in Rochester, Minnesota, a tertiary care center with a local primary care practice. Included individuals have stage 3 AKI during their hospitalization, do not require dialysis at discharge, have a local primary care provider (PCP), and discharge to home. Patients unable or unwilling to provide informed consent and recipients of any transplant within 100 days of enrollment are excluded. Consented patients are randomized to receive the intervention (i.e., ACT Program) or usual care. The ACT Program intervention includes pre-discharge kidney health education from nurses and coordinated post-discharge laboratory monitoring (serum creatinine and urine protein assessment) and follow-up with a PCP and pharmacist within 14 days. The Usual Care group receives no specific study-related intervention and any aspects of AKI care are at the direction of the treating team. This study will examine feasibility of the ACT Program, including recruitment, randomization, and retention in a trial setting, and intervention fidelity. Feasibility and acceptability of participating in the ACT Program will also be examined in qualitative interviews with patients and staff and through surveys. Qualitative interviews will be deductively and inductively coded and themes compared across data types. Observations of clinical encounters will be examined for discussion and care plans related to kidney health. Descriptive analyses will summarize quantitative measures of the feasibility and acceptability of ACT. Participants' knowledge about kidney health and quality of life and process outcomes (e.g., type and timing of laboratory assessments) will be described for both groups. Clinical outcomes (e.g., unplanned rehospitalization) up to 12 months will be compared with Cox proportional hazards models.
Results:
This study received funding from the Agency for Healthcare Research and Quality on April 21, 2021, and was approved by the Institutional Review Board on December 14, 2021. As of March 14, 2023, 17 participants each have been enrolled in the Intervention and Usual Care groups.
Conclusions:
Feasible and generalizable AKI survivor care delivery models are needed to improve care processes and health outcomes. This pilot trial will test the ACT program, which uses a multidisciplinary model focused on primary care to address this gap. Clinical Trial: NCT05184894
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