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

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ClinicalTrials.gov Identifier: NCT01459770
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : April 6, 2017
Sponsor:
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
Information provided by (Responsible Party):
Providence Medical Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease End-Stage Renal Disease Other: Medication Information Transfer Intervention Other: Usual care for hospital discharge Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
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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 )
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 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