Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD (CKD/ESRD-MIT)
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|ClinicalTrials.gov Identifier: NCT01459770|
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease End-Stage Renal Disease||Other: Medication Information Transfer Intervention Other: Usual care for hospital discharge||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2016|
Active Comparator: control
usual care for hospital discharge:
Other: Usual care for hospital discharge
Patients will receive medication information according to standard practice for discharge of hospitalized patients.
Active Comparator: intervention
pharmacist administered medication information transfer intervention
Other: Medication Information Transfer Intervention
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.
- acute care utilization [ Time Frame: 90 days ]Acute care utilization defined by emergency department visits and hospitalizations in the first 30 and 90 days after discharge from the index hospitalization.
- CKD status, risk factors and complications [ Time Frame: 30 and 90 days ]blood pressure, eGFR, urine albumin/creatinine ratio, fasting glucose, HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium.
- ESRD status, risk factors and complications: [ Time Frame: 30 and 90 days ]blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459770
|United States, Washington|
|Providence Sacred Heart Medical Center & Children's Hospital|
|Spokane, Washington, United States, 99204|
|Principal Investigator:||Katherine R Tuttle, MD||Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of Medicine|
|Principal Investigator:||Cynthia L Corbett, PhD||Washington State University College of Nursing|