Medication Intervention in Transitional Care to Optimize CKD Outcomes & Costs (CKD-MIT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease NKF Classification |
Other: Medication Information Transfer Intervention Other: Usual care for hospital discharge |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Medication Intervention in Transitional Care to Optimize CKD Outcomes & Costs |
- acute care utilization [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]identification of intermediate markers that define CKD status to include: eGFR, urine albumin:creatinine ratio, fasting glucose, HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium.
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (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
The 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 chronic kidney disease (CKD) 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. 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 who are transitioning to home, accurate and comprehensive information transfer is essential to optimal medication management. CKD 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 in CKD. 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. 2. Evaluate the impact of transitional care strategies on management of CKD risk factors and complications.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalized patients
- > 21 years of age
- Diagnosis of CKD stages 3-5
- Patients on hemodialysis or peritoneal dialysis
Exclusion Criteria:
1. Kidney Transplant
Contacts and Locations| Contact: Ruth A Franks, RN | 509-474-4327 | ruth.franks@providence.org |
| United States, Washington | |
| Providence Sacred Heart Medical Center & Children's Hospital | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Ruth A Franks, RN 509-474-4327 ruth.franks@providence.org | |
| Principal Investigator: Katherine R Tuttle, MD | |
| Principal Investigator: Cynthia L Corbett, PhD | |
| Principal Investigator: | Katherine R Tuttle, MD | Providence Medical Research Center |
| Principal Investigator: | Cynthia L Corbett, PhD | Providence Medical Research Center |
More Information
No publications provided
| Responsible Party: | Providence Medical Research Center |
| ClinicalTrials.gov Identifier: | NCT01459770 History of Changes |
| Other Study ID Numbers: | 1 R34 DK094016-01, R34DK094016-01 |
| Study First Received: | October 24, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
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 May 16, 2013