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

NCT ID: NCT01459770

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

usual care for hospital discharge:

1. CKD group
2. ESRD group

Group Type ACTIVE_COMPARATOR

Usual care for hospital discharge

Intervention Type OTHER

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

intervention

pharmacist administered medication information transfer intervention

1. CKD group
2. ESRD group

Group Type ACTIVE_COMPARATOR

Medication Information Transfer Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Usual care for hospital discharge

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Hospitalized patients
2. \> 21 years of age
3. Diagnosis of CKD stages 3-5, not treated by dialysis


1. Hospitalized patients
2. \> 21 years of age
3. Patients treated with hemodialysis or peritoneal dialysis

Exclusion Criteria

1\. Kidney Transplant
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington State University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Health Sciences & Services Authority of Spokane County

UNKNOWN

Sponsor Role collaborator

Providence Sacred Heart Medical Center & Children's Hospital

OTHER

Sponsor Role collaborator

Providence Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine R Tuttle, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of Medicine

Cynthia L Corbett, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University College of Nursing

Locations

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Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Alicic RZ, Short RA, Corbett CL, Neumiller JJ, Gates BJ, Daratha KB, Barbosa-Leiker C, McPherson S, Chaytor NS, Dieter BP, Setter SM, Tuttle KR. Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics. Am J Nephrol. 2016;44(2):122-9. doi: 10.1159/000447019. Epub 2016 Aug 4.

Reference Type DERIVED
PMID: 27487357 (View on PubMed)

Other Identifiers

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R34DK094016-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RFP # 7

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R34DK094016-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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