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| ID | Type | Description | Link |
|---|---|---|---|
| R03HS028060-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKI in Care Transitions (ACT) Group | Experimental | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. |
|
| Usual Care Group | No Intervention | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKI in Care Transitions (ACT) program | Behavioral | Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects to Complete the ACT Program | Total number of subjects to complete the full ACT program intervention | 30 days after hospitalization |
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Inclusion Criteria:
- Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Barreto, PharmD, RPh | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213187 | Derived | May HP, Griffin JM, Herges JR, Kashani KB, Kattah AG, Mara KC, McCoy RG, Rule AD, Tinaglia AG, Barreto EF. Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. JMIR Res Protoc. 2023 May 22;12:e48109. doi: 10.2196/48109. |
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Eligible patients were identified using an electronic health record (EHR)- embedded list of adults (≥18 years) hospitalized at Mayo Clinic in Rochester from January 2022 to July 2023 who met stage 3 AKI criteria based on serum creatinine rise or urine output decline during a hospitalization and had a local address.
Candidate participants were approached within 48-72 hours of discharge to obtain written informed consent and randomized 1:1 to the ACT intervention or usual care.
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| ID | Title | Description |
|---|---|---|
| FG000 | AKI in Care Transitions (ACT) Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge. |
| FG001 | Usual Care Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AKI in Care Transitions (ACT) Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects to Complete the ACT Program | Total number of subjects to complete the full ACT program intervention | Posted | Count of Participants | Participants | 30 days after hospitalization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AKI in Care Transitions (ACT) Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Barreto, PharmD, MS | Mayo Clinic | 507-284-2511 | barreto.erin@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Oct 10, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2021 | Feb 2, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D010360 | Patient Transfer |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006760 | Hospitalization |
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| BG001 | Usual Care Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Preadmission baseline eGFR | Median | Inter-Quartile Range | mL/min/1.73m^2 |
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| Discharge eGFR | Median | Inter-Quartile Range | mL/min/1.73m^2 |
|
| AKI Recovery stage at discharge | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 1 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Usual Care Group | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. | 1 | 25 | 0 | 25 | 0 | 25 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |