Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD (CKD/ESRD-MIT)
Primary Purpose
Chronic Kidney Disease, End-Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Information Transfer Intervention
Usual care for hospital discharge
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease focused on measuring glomerular filtration rate, albuminuria, medical therapy, hospital discharge, hospital readmission, CKD complications, CKD risk factors
Eligibility Criteria
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
Sites / Locations
- Providence Sacred Heart Medical Center & Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
intervention
Arm Description
usual care for hospital discharge: CKD group ESRD group
pharmacist administered medication information transfer intervention CKD group ESRD group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
ESRD status, risk factors and complications:
blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium
Full Information
NCT ID
NCT01459770
First Posted
October 24, 2011
Last Updated
April 4, 2017
Sponsor
Providence Medical Research Center
Collaborators
Washington State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Health Sciences & Services Authority of Spokane County, Providence Sacred Heart Medical Center & Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01459770
Brief Title
Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD
Acronym
CKD/ESRD-MIT
Official Title
Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Medical Research Center
Collaborators
Washington State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Health Sciences & Services Authority of Spokane County, Providence Sacred Heart Medical Center & Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-Stage Renal Disease
Keywords
glomerular filtration rate, albuminuria, medical therapy, hospital discharge, hospital readmission, CKD complications, CKD risk factors
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
usual care for hospital discharge:
CKD group
ESRD group
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
pharmacist administered medication information transfer intervention
CKD group
ESRD group
Intervention Type
Other
Intervention Name(s)
Medication Information Transfer Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care for hospital discharge
Intervention Description
Patients will receive medication information according to standard practice for discharge of hospitalized patients.
Primary Outcome Measure Information:
Title
acute care utilization
Description
Acute care utilization defined by emergency department visits and hospitalizations in the first 30 and 90 days after discharge from the index hospitalization.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
CKD status, risk factors and complications
Description
blood pressure, eGFR, urine albumin/creatinine ratio, fasting glucose, HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium.
Time Frame
30 and 90 days
Title
ESRD status, risk factors and complications:
Description
blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium
Time Frame
30 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine R Tuttle, MD
Organizational Affiliation
Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia L Corbett, PhD
Organizational Affiliation
Washington State University College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Sacred Heart Medical Center & Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27487357
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.
Results Reference
derived
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Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD
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