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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK145433-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Kidney Injury in Care Transitions (ACT) Intervention | Experimental | Physicians and nurse practitioners randomized to the ACT intervention group will be provided access to augmented kidney care support for acute kidney injury patients prior to hospital discharge, individualized according to post-discharge risk. |
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| Usual Care | Active Comparator | Physicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Kidney Injury in Care Transitions (ACT) | Behavioral | Clinicians will assign risk-individualized kidney health care prior to hospital discharge for acute kidney injury survivors. Low risk acute kidney injury survivors will receive education prior to hospital discharge, moderate risk acute kidney injury survivors will receive a referral to primary care for laboratory and clinical follow-up within approximately 14-days including a medication review by a pharmacist, and high risk acute kidney injury survivors will be referred to nephrologist-directed care including remote monitoring program (RPM) where available and aligned with the patients goals/values/preferences for up to 90 days after discharge for the highest risk patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-Free Days | Hospital-free days is defined as the total number of days a patient is alive and out of the hospital within the specified time frame. | 90 days, 180 days, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned hospital readmissions or acute care contact or death | Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death | 90-days, 180-days, 1 year |
| Death |
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria | Binary classification of proteinuria in patients with laboratory data available from the scheduled follow-up time | 90 days, 180 days, 1 year |
| Excess days in acute care | Total days a patient spends in any acute care setting in the time interval after discharge, compared to what is expected for similar patients. Includes unplanned readmissions, observation stays, and emergency department visits. |
Inclusion Criteria:
Clinician subjects
Patient subjects:
Exclusion Criteria:
Clinician subjects: Physicians and advanced practice providers who:
Patient subjects
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell C. Strand | Contact | 507-293-0952 | strand.mitchell@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin F. Barreto, Pharm.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System-Mankato | Not yet recruiting | Mankato | Minnesota | 56001 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.
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5 years post primary completion date
Data will be made available to researchers whose research proposal is approved by the principal investigator in addition to approval by the researcher's local site ethics review committee (such as an IRB) and an executed data use agreement.
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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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|
| Usual Care | Behavioral | Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge. |
|
Death after discharge
| 90-days, 180-days, 1-year |
| AKI recurrence | Total number of patients to experience a recurrence of acute kidney injury after discharge. | 90 days, 180 days, 1 year |
| Major Adverse Kidney Event | Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline | 90-, 180- days |
| Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline | eGFRcreatinine will be estimated from available serum creatinines checked in routine clinical practice at the study time points, and absolute and relative change in eGFR in milliliters per minute per 1.73m2 will be determined. | 90 days, 180 days, 1 year |
| Chronic kidney disease (CKD) | Total number of patients with new or worsening chronic kidney disease (CKD) post discharge | 90 days, 180 days, 1 year |
| End-stage kidney disease (ESKD) | Total number of patients with end-stage kidney disease (ESKD) post discharge | 90 days, 180 days, 1 year |
| Kidney transplantation | Total number of patients that require kidney transplantation post discharge | 90 days, 180 days, 1 year |
| Major adverse cardiovascular event | Incidence of major adverse cardiovascular event | 90-days, 180-days, 1 year |
| Provider and laboratory follow-up | Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up | 30-days, 90-days, 180-days |
| Post-discharge serum creatinine evaluation | Assessment of serum creatinine in the post-discharge interval | time to first, 30-days, 90-days, 180-days |
| Post-discharge urine protein evaluation | Assessment of urine protein in the post-discharge interval | time to first, 30-days, 90-days, 180-days |
| Primary care follow-up | Occurrence of a completed primary care encounter after discharge | time to first, 30-days, 90-days, 180-days |
| Nephrology follow-up | Occurrence of completed nephrology follow-up during the post-discharge interval | time to first, 30-days, 90-days, 180-days |
| Pharmacist follow-up | Occurrence of a completed pharmacist encounter in the post-discharge interval | time to first, 30-days, 90-days, 180-days |
| Guideline concordant care | Occurrence of provider and laboratory and initiation of renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, or glucagon-like peptide-1 agonists in CKD. | 90 days, 180 days, 1 year |
| Engaged in remote monitoring program (RPM) program | Total number of patients who submitted one or more sets of vitals/symptoms through the supplied technology or completed one of the scheduled laboratory assessments as part of the remote monitoring program (RPM) | 30 days, 90 days |
| 90 days, 180 days, 1 year |
| Hierarchical composite outcome |
| 90 days, 180 days, 1 year |
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Mayo Clinic Health System-Eau Claire Clinic | Not yet recruiting | Eau Claire | Wisconsin | 54703 | United States |
|
| 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 |