This trial is active, not recruiting.

Conditions chronic kidney disease, end-stage renal disease
Treatments medication information transfer intervention, usual care for hospital discharge
Sponsor Providence Medical Research Center
Collaborator Washington State University
Start date November 2011
End date December 2015
Trial size 120 participants
Trial identifier NCT01459770, 1R34DK094016-01, R34DK094016-01, RFP # 7


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
(Active Comparator)
usual care for hospital discharge: CKD group ESRD group
usual care for hospital discharge
Patients will receive medication information according to standard practice for discharge of hospitalized patients.
(Active Comparator)
pharmacist administered medication information transfer intervention CKD group ESRD group
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.

Primary Outcomes

acute care utilization
time frame: 90 days

Secondary Outcomes

CKD status, risk factors and complications
time frame: 30 and 90 days
ESRD status, risk factors and complications:
time frame: 30 and 90 days

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria for CKD arm: 1. Hospitalized patients 2. > 21 years of age 3. Diagnosis of CKD stages 3-5, not treated by dialysis Inclusion Criteria for ESRD arm: 1. Hospitalized patients 2. > 21 years of age 3. Patients treated with hemodialysis or peritoneal dialysis Exclusion Criteria: 1. Kidney Transplant

Additional Information

Official title Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Principal investigator Katherine R Tuttle, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Providence Medical Research Center.