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Completed

NCT Number: NCT01459770

Medication Intervention in Transitional Care to Optimize Outcomes & Costs for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for CKD arm:

  • Hospitalized patients
  • > 21 years of age
  • Diagnosis of CKD stages 3-5, not treated by dialysis

Inclusion criteria

for ESRD arm:

  • Hospitalized patients
  • > 21 years of age
  • Patients treated with hemodialysis or peritoneal dialysis

Exclusion criteria

  • Kidney Transplant

Treatment and study plan

Medication Information Transfer Intervention

Other

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.

Usual care for hospital discharge

Other

Patients will receive medication information according to standard practice for discharge of hospitalized patients.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Providence Medical Research Center

Other

Collaborators

  • Health Sciences & Services Authority of Spokane County
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Providence Sacred Heart Medical Center & Children's Hospital
  • Washington State University

Registry information

Official study title

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

Acronym: CKD/ESRD-MIT

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2011
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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