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

April 4, 2017 updated by: Providence Medical Research Center

Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center & Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control

usual care for hospital discharge:

  1. CKD group
  2. ESRD group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 and 90 days
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
30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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