Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD

Study Overview
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Brief Summary
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Transitional care strategies focused on enhancing the accuracy and comprehensiveness of medication information transfer will lead to improved health outcomes among hospitalized patients with chronic kidney disease.

Detailed Description
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Patients with CKD and ESRD have more co-morbidities, are hospitalized more often and for longer lengths of stay, and incur greater healthcare costs than patients with other chronic conditions. Enhanced hospital to home transitional care interventions have been shown to improve medication information transfer, reduce hospital readmissions, and slow the progression of declining health in the general population of hospitalized patients. What is not known is the impact enhanced transitional care can have for a very high-risk population, such as those with CKD and ESRD. Interventions that prevent or slow CKD progression, i.e. blood pressure control and intensive glycemic control in patients with diabetes, are all highly dependent on meticulous medication management. For hospitalized patients with CKD or ESRD who are transitioning to home, accurate and comprehensive information transfer is essential to optimal medication management. CKD and ESRD patients are in critical need of improved transitional care that includes accurate and comprehensive medication information transfer. The main objective of this application is to pilot-test the effectiveness of a medication information transfer intervention to improve clinically-relevant outcomes. To this end, the following Specific Aims will be achieved: 1. Evaluate the impact of transitional care interventions on acute care utilization following hospital discharge among patients with CKD or ESRD. 2. Evaluate the impact of transitional care strategies on management of CKD or ESRD management and complications.

Official Title
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Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD

Conditions
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Chronic Kidney Disease, End-Stage Renal Disease

Intervention / Treatment
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* Other: Medication Information Transfer Intervention
* Other: Usual care for hospital discharge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for CKD arm: Hospitalized patients > 21 years of age Diagnosis of CKD stages 3-5, not treated by dialysis Inclusion Criteria for ESRD arm: Hospitalized patients > 21 years of age Patients treated with hemodialysis or peritoneal dialysis Exclusion Criteria: 1. Kidney Transplant

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>usual care for hospital discharge: CKD group ESRD group | Other: Usual care for hospital discharge<br>* Patients will receive medication information according to standard practice for discharge of hospitalized patients.<br>|
| Active Comparator: intervention<br>pharmacist administered medication information transfer intervention CKD group ESRD group | Other: Medication Information Transfer Intervention<br>* A pharmacist will visit participants randomized to the intervention group in their homes within 5 days of hospital discharge to administer the 5As Medication Self-Management intervention: Assessment, Advise, Agreement, Assistance, Arrangements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute care utilization | Acute care utilization defined by emergency department visits and hospitalizations in the first 30 and 90 days after discharge from the index hospitalization. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD status, risk factors and complications | blood pressure, eGFR, urine albumin/creatinine ratio, fasting glucose, HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium. | 30 and 90 days | 
| ESRD status, risk factors and complications: | blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium | 30 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical therapy, hospital discharge, CKD risk factors, glomerular filtration rate, albuminuria, hospital readmission, CKD complications