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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| University of Calgary | OTHER |
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Nearly one in ten people who are hospitalized in Canada develop a complication with sudden loss of kidney function, called acute kidney injury (AKI). AKI may lead to other severe health problems after discharge home, such as kidney failure requiring dialysis treatment, heart failure, heart attacks, stroke, and even premature death. Discharge from hospital to home can be a difficult transition where there are often gaps in identification, communication, care coordination, education, and planning of care for AKI. The study team will co-design and evaluate a tailored post-discharge care plan that is based on the risk of later kidney problems and uses currently available, yet untapped digital innovation to improve the health and experience of people with AKI.
This study will be built into Alberta's new Epic Systems based provincial electronic health record (EHR). The plan is to use digital tools in the EHR to identify all people in Alberta hospitals that have had an AKI event and are at increased risk of long-term complications. Half will randomly be assigned to receive a tailored care plan based on their risk at hospital discharge while the other half will receive care as it is currently provided by their healthcare team. The electronic health system will automatically calculate a patient's risk and report this risk in their chart along with recommendations for care. The study team includes patients, healthcare providers, and health system decision makers needed to co-develop the proposed strategy and introduce the changes needed to deliver this intervention. The investigators will study whether this strategy can reduce health problems that may happen after AKI including death, chronic kidney disease (CKD), kidney failure, heart attacks, and stroke. The investigators will also determine if the approach improves patient experience during the transition from hospital to home. This study has the potential to revolutionize how we care for people that leave hospital after having AKI.
Acute kidney injury (AKI) is common in hospitalized patients and associated with poor long-term outcomes including kidney failure, cardiovascular (CV) events, and death, with highest risk in older adults. The transition of hospitalized patients with AKI to home is challenging, with many care gaps. Identifying those at highest risk of adverse post-discharge outcomes and delivering interventions to reduce the risk of progressive kidney and CV disease via appropriate, acceptable, and efficient intervention strategies are needed. Our team has developed and externally validated a risk prediction model for hospitalized adults with AKI, which can estimate the risk of advanced chronic kidney disease (eGFR<30mL/min/1.73m2 or kidney failure). The investigators used this risk model to guide follow-up in a pilot trial for AKI survivors within Alberta (ClinicalTrials.gov: NCT02915575). The investigators have found that a risk-guided strategy to follow-up is a feasible approach to close gaps in care; however, larger studies are required to evaluate broader implementation, and impact on patient-centered outcomes, costs, and sustainability in a real-world setting. Alberta Health Services (AHS) has implemented a new province-wide clinical information system which provides a unique opportunity to use digital health technology to design and evaluate a risk-guided hospital-to-home transition of care intervention that builds upon previous work.
OBJECTIVES AND METHODS:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The proposed experimental intervention will incorporate our risk prediction model which will be used in combination with a patients medical profile to guide the hospital to home transition of care for low, medium and high-risk groups of patients. Patients will receive transition of care plans that are tailored to their medical profile and embedded within standardized discharge pathways within the electronic health record |
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| Usual Care | No Intervention | The usual care group will not receive the risk-guided transition of intervention and will receive standard hospital discharge care in accordance with local health system standards (Alberta Health Services), with recommendations for kidney function, proteinuria and laboratory testing at 90 days after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk-guided transition of care intervention delivered through an integrated digital health strategy | Other | Patients will receive transition of care plans that are tailored to their medical profile and risk and embedded within standardized discharge pathways within the EHR- Education and self-management guidance about AKI for patients, Medication guidance based on evidence-based indications for reducing risk of cardiac and kidney outcomes, Recommendations for subsequent laboratory testing of kidney function, proteinuria and electrolytes according to clinical characteristics and risks, Recommendations for timing and nature of PCP follow-up, Information about the patient's AKI and subsequent management provided to PCPs through discharge summary, Recommendations for outpatient Pharmacy follow-up for medication reconciliation and review according to patient risk and medication management gaps, Recommendations for Nephrology referral for high risk patients |
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness outcome | The primary outcome of the study is major adverse kidney or CV events within 2 years after discharge, defined as the composite of death, kidney failure (receipt of maintenance dialysis, kidney transplant or eGFR < 15 mL/min/1.73m2 for 4 weeks or more), or hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms) | 2 years after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Clinical Outcomes-Death | Death from any cause within 2 years of discharge | 2 years of discharge |
| Safety Outcomes- Hyperkalemia | Serum potassium ≥ 6.0 mEq/L on outpatient lab testing within one year of discharge |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neesh Pannu | Contact | 780 492 8519 | npannu@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Neesh Pannu | University of Alberta | Principal Investigator |
| Matthew James | University of Calgary | Principal Investigator |
| Tyrone Harrison |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | Canada |
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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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This is a waiver of consent trial, participants will be randomized to an enhanced discharge care pathway vs usual care in the electronic health record.
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| within 1 year of discharge |
| Safety Outcomes-Hospitalization for Kidney Disease Ambulatory Care Specific Condition | Hospitalization for a Kidney Disease Ambulatory Care Specific Condition (Congestive Heart Failure, Volume Overload, Hyperkalemia, or Hypertensive Emergency) within one year after discharge (based on ICD-10 coding algorithms) | within 1 year of discharge |
| Safety Outcomes-All Cause Hospitalization or ED Visit | All-cause hospitalization or ED visits within 30 and 90 days of discharge | 30 and 90 days of discharge |
| Secondary Clinical Outcomes-Kidney Failure | Receipt of maintenance dialysis, kidney transplant, or eGFR < 15 mL/min/1.73m2 for 4 weeks or more) within 2 year of discharge | within 2 years of discharge |
| Secondary Clinical Outcomes-Hospitalization for CV Events | Hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms) within 2 years of hospital discharge | Within 2 years of hospital discharge |
| Patient Experience | Patient experience will be assessed using a survey with eight questions related to AKI transition in care administered by AHS via phone at 6 ± 2 weeks post discharge to a random estimated 10% of patients in both control and intervention arms of the study. The sampling frame will be designed to recruit an equal number of patients from each CKD risk strata. | 6 ± 2 weeks post discharge |
| Implementation Outcomes | Implementation outcomes will include the proportion of eligible patients included in the study who receive each element of the enhanced care intervention that is recommended by the practice advisory, according to their risk strata. These will include documentation of AKI in the problem list, AKI discharge communication sent to the patient's primary care provider at discharge, after visit summary printed for the patient prior to discharge, referral to community pharmacist when recommended, referral to nephrologist when recommended, and laboratory test (eGFR, urine ACR, electrolytes) ordered for within 2 or 4 weeks of discharge according to recommendations. | 2 or 4 weeks of discharge |
| Process of Care Outcomes | Process of care outcomes will include the proportion of patients who receive the recommended kidney function monitoring (eGFR, urine ACR, electrolytes) within 2 or 4 weeks after discharge, the proportion of patients with a recommendation for and who receive a guideline-indicated medication for kidney and cardiovascular risk reduction (RAAS blockers, SGLT-2 inhibitors, finerenone, and statin prescription) within 90 days of discharge, the proportion of patients reviewed by a community pharmacist within 4 weeks when recommended, and the proportion of patients seen by a nephrologist within 4 weeks when recommended. | within 2 or 4 weeks or 90 days of discharge |
| University of Calgary |
| Principal Investigator |
| University of Alberta Hospital | Recruiting | Edmonton | Alberta | Canada |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |