NCT01459770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

4.1 years

First QC Date

October 24, 2011

Last Update Submit

April 4, 2017

Conditions

Keywords

glomerular filtration ratealbuminuriamedical therapyhospital dischargehospital readmissionCKD complicationsCKD risk factors

Outcome Measures

Primary Outcomes (1)

  • acute care utilization

    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 Outcomes (2)

  • CKD status, risk factors and complications

    30 and 90 days

  • ESRD status, risk factors and complications:

    30 and 90 days

Study Arms (2)

control

ACTIVE COMPARATOR

usual care for hospital discharge: 1. CKD group 2. ESRD group

Other: Usual care for hospital discharge

intervention

ACTIVE COMPARATOR

pharmacist administered medication information transfer intervention 1. CKD group 2. ESRD group

Other: Medication Information Transfer Intervention

Interventions

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

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

control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients
  • \> 21 years of age
  • Diagnosis of CKD stages 3-5, not treated by dialysis
  • Hospitalized patients
  • \> 21 years of age
  • Patients treated with hemodialysis or peritoneal dialysis

You may not qualify if:

  • \. Kidney Transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, 99204, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicAlbuminuria

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsProteinuriaUrination DisordersUrological ManifestationsSigns and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 26, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

April 6, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations