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

Chronic Kidney Disease Clinical Trial

— CKD/ESRD-MIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459770
• Other study ID #: 1R34DK094016-01
• Secondary ID: R34DK094016-01RF
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: April 4, 2017
• Start date: November 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: Providence Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

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.
• Usual care for hospital discharge
Patients will receive medication information according to standard practice for discharge of hospitalized patients.

Locations

Country	Name	City	State
United States	Providence Sacred Heart Medical Center & Children's Hospital	Spokane	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Providence Medical Research Center	Health Sciences & Services Authority of Spokane County, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Providence Sacred Heart Medical Center & Children's Hospital, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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