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

Primary Purpose

Acute Kidney Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Study Physician/Advance Practice Provider

Nurse Navigator

Pharmacist

Patient Education

About this trial

This is an interventional health services research trial for Acute Kidney Injury focused on measuring acute kidney injury, process of care, acute renal failure, kidney failure, kidney damage, pragmatic, nurse navigator, pharmacist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham
Yale University
University of Maryland
Johns Hopkins University
MetroHealth
Cleveland Clinic Foundation
Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal Process of Care Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital-Free Days (HFDs) through day 90

Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.

Secondary Outcome Measures

Rate of Major Adverse Kidney Events (MAKE) at 180 days

MAKE-180 composite outcome of death, dialysis and assessment of kidney function defined as: death within 180 days of index hospital discharge; need for dialysis at 180 days after index hospital discharge; or serum creatinine >2x baseline at 180 days after index hospital discharge

Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days

Episodes of recurrent AKI during subsequent all-cause hospitalizations will be adjudicated based on hospitalization data, defining recurrent episodes of AKI based on an increase in serum creatinine of >50% relative to the lowest-known value preceding or including the rehospitalization.

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

HR-QOL will be assessed with the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) HRQoL measure. The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health, which are rescaled into a standardized score (T-score) with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher T-score represents more of the concept being measured. Thus, a person who has T-scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population.

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

AKI-Specific HR-QOL will be assessed with the 6-item Chronic Kidney Disease Quality of Life (CKD-QoL) measure. The CKD-QoL comprehensively represents CKD-specific quality of life and yields a single summary impact score. Norm-based scoring is used (linearly transformed to have a mean of 50 and an SD of 10) in which a higher score indicates worse QOL impact.

Change from baseline in Interactions with Providers at 180 days.

Provider interactions will be assessed with the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) and 8-item Client Satisfaction Questionnaire (CSQ-8) measures. The PEPPI provides a summary score ranging for 5 to 25 (25 = sighted patient self-efficacy). The CSQ-8 is a structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.

Change from baseline in Social Support at 180 days.

Social support will be assessed with the 4-item PROMIS Emotional Support and 4-item PROMIS Instrumental Support short forms. The Emotional Support and Instrumental Support measures each produce a summary score, which are rescaled into a standardized score (T-score) with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher T-score represents more of the concept being measured. Thus, a person who has a T-score of 60 is one standard deviation better (more healthy) than the general population.

Full Information

NCT ID

NCT05805709

First Posted

February 23, 2023

Last Updated

September 6, 2023

Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT05805709

Brief Title

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

Acronym

COPE-AKI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 5, 2023 (Actual)

Primary Completion Date

June 5, 2026 (Anticipated)

Study Completion Date

March 5, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

acute kidney injury, process of care, acute renal failure, kidney failure, kidney damage, pragmatic, nurse navigator, pharmacist

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Masking Description

Participants and the clinical care teams (nurse navigator, pharmacist, and study physician) will not be masked due to unblinded nature of the intervention. Research coordinators who carry out screening, enrollment, and study visits at baseline, 3, 6 and 12 months will be masked from participant group assignment. Similarly, study visits performed by research coordinator at baseline (enrollment), 3 months and 12 months will be masked. Similarly, assessment of study endpoints will be blinded to group assignment.

Allocation

Randomized

Enrollment

2145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multimodal Process of Care Intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Study Physician/Advance Practice Provider

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Nurse Navigator

Intervention Description

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 including both routine (pre-scheduled) and ad hoc (urgent or emergency); enhance adherence with prescribed medical care and follow-up appointments; and serve as a resource to the patient to answer questions about their AKI-related management, facilitate medical and associated care and provide enhanced psychosocial support.

Intervention Type

Other

Intervention Name(s)

Pharmacist

Intervention Description

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, evaluation of non-prescription medication use, medication/disease education and social support.

Intervention Type

Other

Intervention Name(s)

Patient Education

Intervention Description

Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.

Primary Outcome Measure Information:

Title

Hospital-Free Days (HFDs) through day 90

Description

Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Rate of Major Adverse Kidney Events (MAKE) at 180 days

Description

Time Frame

180 days

Title

Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days

Description

Time Frame

180 days

Title

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

Description

Time Frame

180 days

Title

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

Description

Time Frame

180 days

Title

Change from baseline in Interactions with Providers at 180 days.

Description

Time Frame

180 days

Title

Change from baseline in Social Support at 180 days.

Description

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beata Pasek, EdD

Phone

412-246-6931

bbp10@pitt.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kaleab Abebe, PhD

kza3@pitt.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaleab Abebe, PhD

Organizational Affiliation

Univerisity of Pittsburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Linda Fried, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul Palevsky, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sandy Kane-Gill, PharmD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia Busta

First Name & Middle Initial & Last Name & Degree

Javier Neyra, MD

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Perez

First Name & Middle Initial & Last Name & Degree

Francis Wilson, MD

Facility Name

University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shannon Hawkins, BSN

First Name & Middle Initial & Last Name & Degree

Matthew Weir, MD

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pam Corona Villalobos, MD

First Name & Middle Initial & Last Name & Degree

Chirag Parikh, MD PhD

Facility Name

MetroHealth

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Figueroa

First Name & Middle Initial & Last Name & Degree

Edward Horwitz, MD

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Savannah Gagnon, BS

First Name & Middle Initial & Last Name & Degree

Emilio Poggio, MD

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kailey Pope, BS

First Name & Middle Initial & Last Name & Degree

Edward Siew, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the University of Pittsburgh Data Coordinating Center (DCC). This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the DCC research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository.

IPD Sharing Time Frame

Data collected for this study will be analyzed and stored at the University of Pittsburgh Scientific & Data Research Center (SDRC). Six months after publication of the primary manuscript or 18 months after study completion, whichever occurs first, the de-identified, archived data will be transmitted to and stored at the NIDDK Central Repository, for use by other researchers including those outside of the study. Permission to transmit data to the NIDDK Central Repository will be included in the informed consent.

Learn more about this trial

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

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