A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

Official title

Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial

Overview

The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.

Detailed description

The primary study hypotheses for the COPE-AKI study are: compared to usual care, patients randomized to a multimodal intervention will have increased odds of more hospital-free days through 90 days (primary) and lower rates of major adverse kidney events (MAKE) at 180 days, lower rates of recurrent AKI at 180 days, and greater improvements in patient-reported outcomes over 90 days (secondary).

The primary outcome is hospital-free days through 90 days of follow up, defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status, based on the determination made by the corresponding hospital. Key secondary outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes: global health related quality of life, AKI-specific health related quality of life, provider interactions, and social support (30, 90, 180, 365 days).

A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Participants in the usual care arm will be provided information about their kidney disease, nephrotoxins to be avoided, and the importance of follow up with a physician will be emphasized.

Interventions

• Other Study Physician/Advance Practice Provider
  The nephrologist and/or nephrology-associated advanced practice provider (APP) at each site will lead the intervention team for the duration of the study. The study physicians will fulfil two main roles: (a) Provide supervision to the rest of the study team and (b) conduct a discharge assessment to triage and make recommendations for follow-up care.
• Other Nurse Navigator
  The nurse navigator will be the primary contact for the participants assigned to the intervention group for the study. The navigator will obtain contact information, information about the patient's usual care providers and pharmacy, review medications, show the participant how to use the home blood pressure machine and scales and arrange for follow-up visits. The role of the nurse navigator will be to monitor the participant's medical condition; facilitate scheduling of needed medical follow-up
• Other Pharmacist
  The pharmacist will complete the medication reconciliation and medication regimen review per the predetermined checklist, via telemedicine if agreeable to the patient. The goal of the patient/caregiver-pharmacist interaction is to cover the following: avoidance of nephrotoxins when possible and appropriate, appropriate dosing of renally cleared drugs, review for drug-drug interactions, monitoring appropriate use of chronic medications, medication adherence, monitor for adverse drug reactions, ev
• Other Patient Education
  Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.

Primary outcome measures

• Hospital-Free Days (HFDs) through day 90 [Time frame: 90 days]

Secondary outcome measures (6)

• Rate of Major Adverse Kidney Events (MAKE) at 180 days [Time frame: 180 days]
• Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days [Time frame: 180 days]
• Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 180 days. [Time frame: 180 days]
• Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 180 days. [Time frame: 180 days]
• Change from baseline in Interactions with Providers at 180 days. [Time frame: 180 days]
• Change from baseline in Social Support at 180 days. [Time frame: 180 days]

Eligibility criteria

Inclusion criteria

• Aged ≥ 18 years
• Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements >12 hours apart)

Exclusion criteria

• AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
• Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:

• Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
• Previous kidney transplant recipient
• On chronic dialysis
• Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
• Index hospitalization involving nephrectomy
• Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
• Continued dialysis dependence at time of discharge
• Previous (within 6 months) or new referral to a nephrologist for care specifically for:

• Previous or new diagnosis of glomerulonephritis
• Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
• Active treatment for acute interstitial nephritis
• Non-kidney end-organ failure:

• Class IV congestive heart failure
• Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) > 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
• End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
• Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
• Primary goal of care is palliation: life expectancy <6 months
• Pregnancy
• Vulnerable populations

• Persons incarcerated
• Persons institutionalized
• Inability to provide informed consent

a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)

• Concurrent enrollment in a separate greater than minimal risk interventional trial
• Inability to participate in either in-person or remote visits

a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF)

• Discharge to long-term acute care facility or other hospital-based location

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 9 centers

• University of Alabama at Birmingham — Birmingham
• Yale University — New Haven
• Cleveland Clinic Weston Hospital — Weston
• University of Maryland — Baltimore
• Johns Hopkins University — Baltimore
• MetroHealth — Cleveland
• Cleveland Clinic Foundation — Cleveland
• Nashville VA Medical Center — Nashville
• … and 1 more center

Identifiers

NCT: NCT05805709 · STUDY21080024 · 1U01DK130010 · 1U01DK129989 · 1U01DK129980 · 1U01DK129984

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗