Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05805709
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-02-23
Brief Title:
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients the COPE-AKI Trial
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Caring for OutPatiEnts After Acute Kidney Injury COPE-AKI Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE-AKI
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 N2145 will be allocated 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01DK130010 | NIH | None | None |
| 1U01DK129989 | NIH | None | None |
| 1U01DK129980 | NIH | None | None |
| 1U01DK129984 | NIH | None | httpsreporternihgovquickSearch1U01DK129984 |