Clinical trial NCT01459770: Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD
Official title: Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End-Stage Renal Disease
Keywords: glomerular filtration rate
albuminuria
medical therapy
hospital discharge
hospital readmission
CKD complications
CKD risk factors
Lead sponsor: Providence Medical Research Center
Sponsor class: OTHER
Collaborators: name: Washington State University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Health Sciences & Services Authority of Spokane County
name: Providence Sacred Heart Medical Center & Children's Hospital
First posted: 2011-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: acute care utilization
timeFrame: 90 days
Secondary outcomes:
measure: CKD status, risk factors and complications
timeFrame: 30 and 90 days
measure: ESRD status, risk factors and complications:
timeFrame: 30 and 90 days
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital
state: Washington
Study officials:
affiliation: Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of Medicine
name: Katherine R Tuttle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State University College of Nursing
name: Cynthia L Corbett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alicic RZ, Short RA, Corbett CL, Neumiller JJ, Gates BJ, Daratha KB, Barbosa-Leiker C, McPherson S, Chaytor NS, Dieter BP, Setter SM, Tuttle KR. Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics. Am J Nephrol. 2016;44(2):122-9. doi: 10.1159/000447019. Epub 2016 Aug 4.