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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Washington State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Health Sciences & Services Authority of Spokane County, Washington State
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: March 31, 2016
Last verified: October 2015
History of Changes
  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
End-Stage Renal Disease
 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 Outcomes & Costs in CKD & ESRD

Resource links provided by NLM:

U.S. FDA Resources

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, risk factors and complications [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium
Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control

usual care for hospital discharge:

  1. CKD group
  2. ESRD group
 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

  1. CKD group
  2. ESRD group
 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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Washington
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Medical Research Center
Washington State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Health Sciences & Services Authority of Spokane County, Washington State
Providence Sacred Heart Medical Center & Children's Hospital
Investigators
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  R34DK094016-01  RFP # 7 
Study First Received: October 24, 2011
Last Updated: March 31, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
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 September 23, 2016