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Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD (CKD/ESRD-MIT)
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Purpose
| Condition | Intervention |
|---|---|
| Chronic Kidney Disease End-Stage Renal Disease | Other: Medication Information Transfer Intervention Other: Usual care for hospital discharge |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
- 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
| Enrollment: | 120 |
| Study Start Date: | November 2011 |
| Study Completion Date: | April 2016 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Providence Medical Research Center |
| ClinicalTrials.gov Identifier: | NCT01459770 History of Changes |
| Other Study ID Numbers: |
1R34DK094016-01 ( U.S. NIH Grant/Contract ) R34DK094016-01 ( U.S. NIH Grant/Contract ) RFP # 7 ( Other Grant/Funding Number: Washington State Health Sciences & Services Authority ) |
| Study First Received: | October 24, 2011 |
| Last Updated: | April 4, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Providence Medical Research Center:
|
glomerular filtration rate albuminuria medical therapy hospital discharge |
hospital readmission CKD complications CKD risk factors |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on August 18, 2017