Medication Intervention in Transitional Care to Optimize CKD Outcomes & Costs (CKD-MIT)

This study is currently recruiting participants.
Verified May 2013 by Providence Medical Research Center
Sponsor:
Collaborators:
Washington State University
Providence Sacred Heart Medical Center & Children's Hospital
Information provided by (Responsible Party):
Providence Medical Research Center
ClinicalTrials.gov Identifier:
NCT01459770
First received: October 24, 2011
Last updated: May 14, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by Providence Medical Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Hospitalized patients
  2. > 21 years of age
  3. Diagnosis of CKD stages 3-5
  4. Patients on hemodialysis or peritoneal dialysis

Exclusion Criteria:

1. Kidney Transplant

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459770

Contacts
Contact: Ruth A Franks, RN 509-474-4327 ruth.franks@providence.org

Locations
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            
Sponsors and Collaborators
Providence Medical Research Center
Washington State University
Providence Sacred Heart Medical Center & Children's Hospital
Investigators
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