PMID- 37213187
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230920
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 May 22
TI  - Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized 
      Acute Kidney Injury in Care Transitions Pilot Trial.
PG  - e48109
LID - 10.2196/48109 [doi]
LID - e48109
AB  - 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 
      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. 
      Individuals who are included have stage 3 AKI during their hospitalization, do 
      not require dialysis at discharge, have a local primary care provider, and are 
      discharged to their 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 (ie, ACT 
      program) or usual care. The ACT program intervention includes predischarge kidney 
      health education from nurses and coordinated postdischarge laboratory monitoring 
      (serum creatinine and urine protein assessment) and follow-up with a primary care 
      provider 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 the feasibility of the ACT program, 
      including recruitment, randomization and retention in a trial setting, and 
      intervention fidelity. The 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, quality of life, and process outcomes (eg, type and timing of laboratory 
      assessments) will be described for both groups. Clinical outcomes (eg, unplanned 
      rehospitalization) up to 12 months will be compared with Cox proportional hazards 
      models. RESULTS: This study received funding from the Agency for Health Care 
      Research and Quality on April 21, 2021, and was approved by the Institutional 
      Review Board on December 14, 2021. As of March 14, 2023, seventeen 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05184894; 
      https://www.clinicaltrials.gov/ct2/show/NCT05184894. INTERNATIONAL REGISTERED 
      REPORT IDENTIFIER (IRRID): DERR1-10.2196/48109.
CI  - (c)Heather P May, Joan M Griffin, Joseph R Herges, Kianoush B Kashani, Andrea G 
      Kattah, Kristin C Mara, Rozalina G McCoy, Andrew D Rule, Angeliki G Tinaglia, 
      Erin F Barreto. Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 22.05.2023.
FAU - May, Heather P
AU  - May HP
AUID- ORCID: 0000-0001-5704-2867
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Griffin, Joan M
AU  - Griffin JM
AUID- ORCID: 0000-0001-8120-3229
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Herges, Joseph R
AU  - Herges JR
AUID- ORCID: 0000-0003-1592-0371
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Kashani, Kianoush B
AU  - Kashani KB
AUID- ORCID: 0000-0003-2184-3683
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Kattah, Andrea G
AU  - Kattah AG
AUID- ORCID: 0000-0001-7228-9876
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Mara, Kristin C
AU  - Mara KC
AUID- ORCID: 0000-0002-8783-0191
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - McCoy, Rozalina G
AU  - McCoy RG
AUID- ORCID: 0000-0002-2289-3183
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Rule, Andrew D
AU  - Rule AD
AUID- ORCID: 0000-0003-0338-7784
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Tinaglia, Angeliki G
AU  - Tinaglia AG
AUID- ORCID: 0000-0002-2251-9642
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Barreto, Erin F
AU  - Barreto EF
AUID- ORCID: 0000-0002-0996-1487
AD  - Mayo Clinic, Rochester, MN, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT05184894
GR  - R03 HS028060/HS/AHRQ HHS/United States
PT  - Journal Article
DEP - 20230522
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10242466
OTO - NOTNLM
OT  - acute kidney injury
OT  - acute renal failure
OT  - care transitions
OT  - chronic kidney disease
OT  - nephrologists
OT  - randomized controlled trials
COIS- Conflicts of Interest: None declared.
EDAT- 2023/05/22 13:04
MHDA- 2023/05/22 13:05
PMCR- 2023/05/22
CRDT- 2023/05/22 11:54
PHST- 2023/04/11 00:00 [received]
PHST- 2023/04/24 00:00 [accepted]
PHST- 2023/05/22 13:05 [medline]
PHST- 2023/05/22 13:04 [pubmed]
PHST- 2023/05/22 11:54 [entrez]
PHST- 2023/05/22 00:00 [pmc-release]
AID - v12i1e48109 [pii]
AID - 10.2196/48109 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 May 22;12:e48109. doi: 10.2196/48109.