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Patient-centered Care for Acute Kidney Injury (COPE-AKI Trial)

N/A

Recruiting

Led By Sandy Kane-Gill, PharmD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

- Previous or new diagnosis of glomerulonephritis

- Continued dialysis dependence at time of discharge

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a new intervention to usual care to see if it helps people avoid hospital visits for up to 90 days. It will test how it affects kidney health and patient reported outcomes. 2145 people will be randomly assigned to the study.

Who is the study for?

The COPE-AKI trial is for adults over 18 with severe acute kidney injury (AKI) that's lasted at least two days. It's not for those with certain types of kidney diseases, end-stage kidney disease, serious lung or liver conditions, life expectancy under six months, pregnancy, cognitive impairment preventing consent, or if they're in another high-risk study.

What is being tested?

This study compares a special care package including a doctor/advanced provider team-up, nurse navigator support, pharmacist involvement and patient education against the usual care given to AKI patients. The goal is to see if this approach increases the number of days patients stay out of the hospital after discharge.

What are the potential side effects?

Since this trial focuses on process-of-care interventions rather than medications or medical procedures directly affecting health status, specific side effects are not anticipated as part of the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage 2 or 3 kidney injury that has lasted for more than 2 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with glomerulonephritis before or recently.

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I will still need dialysis after leaving the hospital.

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I had a kidney removal surgery during my last hospital stay.

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My kidney function improved quickly after treating a blockage in my urinary system.

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I can participate in both in-person and remote visits.

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I have severe liver disease with a MELD score over 30 or have been diagnosed with hepatorenal syndrome.

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I do not have advanced lung disease like severe COPD, fibrosis, or cystic fibrosis.

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I am currently receiving treatment for kidney inflammation.

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I have received a kidney transplant in the past.

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My kidney injury is due to a specific type of kidney inflammation or blood vessel issue.

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I do not have a genetic disorder causing electrolyte imbalances.

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I have severe heart failure.

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I am being discharged to a specialized care facility or another hospital.

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I have been hospitalized for an organ or stem cell transplant.

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I am on long-term dialysis.

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My main treatment goal is comfort, and I have been told I have less than 6 months to live.

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My kidneys have stopped working properly.

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I have cancer that has spread or needs treatment like chemo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital-Free Days (HFDs) through day 90

Secondary study objectives

Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 180 days.

Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 180 days.

Change from baseline in Interactions with Providers at 180 days.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Process of Care InterventionExperimental Treatment4 Interventions

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.

Group II: Usual CareActive Control1 Intervention

After receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator.

0 / 19Eligibility criteria met