Clinical trial NCT05805709: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
process of care
acute renal failure
kidney failure
kidney damage
pragmatic
nurse navigator
pharmacist
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-10
Enrollment: 2145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, pragmatic, parallel-arm kidney trial conducted to find out if an "enhanced care" team approach can improve a patient's outcomes after hospitalization with acute kidney injury (AKI). 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years
2. 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:

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

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

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

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

    1. Persons incarcerated
    2. Persons institutionalized
13. Inability to provide informed consent

    a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
14. Concurrent enrollment in a separate greater than minimal risk interventional trial
15. 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)
16. Discharge to long-term acute care facility or other hospital-based location

Primary outcomes:
measure: Hospital-Free Days (HFDs) through day 90
timeFrame: 90 days
Secondary outcomes:
measure: Rate of Major Adverse Kidney Events (MAKE) at 180 days
timeFrame: 180 days
measure: Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days
timeFrame: 180 days
measure: Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 180 days.
timeFrame: 180 days
measure: Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 180 days.
timeFrame: 180 days
measure: Change from baseline in Interactions with Providers at 180 days.
timeFrame: 180 days
measure: Change from baseline in Social Support at 180 days.
timeFrame: 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic Weston Hospital
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Nashville
country: United States
facility: Nashville VA Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Univerisity of Pittsburgh
name: Kaleab Abebe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Linda Fried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Paul Palevsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Sandy Kane-Gill, PharmD
role: PRINCIPAL_INVESTIGATOR
References: