- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459770
Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD (CKD/ESRD-MIT)
Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center & Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
1. Kidney Transplant
Study Plan
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:
|
Patients will receive medication information according to standard practice for discharge of hospitalized patients.
|
Active Comparator: intervention
pharmacist administered 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.
|
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
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
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.
Clinical Trials on Chronic Kidney Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
Centre Hospitalier Saint Joseph Saint Luc de LyonNot yet recruitingKidney Failure, Chronic | Diet Habit | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 3B | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 3A (Disorder)France
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
A.C. AbrahamsCompletedEnd Stage Renal Disease | Chronic Kidney Disease | End Stage Kidney Disease | Chronic Kidney FailureNetherlands
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
Clinical Trials on Usual care for hospital discharge
-
Agency for Healthcare Research and Quality (AHRQ)University of Illinois at ChicagoCompletedInterprofessional Relations | Information DisseminationUnited States
-
Weill Medical College of Cornell UniversityBrown University; National Institute on Aging (NIA)Active, not recruiting
-
Weill Medical College of Cornell UniversityAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationMyocardial Infarction | Cardiovascular Diseases | Heart Failure | Stroke | Hypertension | Diabetes Mellitus | Atrial Fibrillation | Transient Ischemic Attack | Hyperlipidemias | Ischemic Heart DiseaseUnited States
-
VA Office of Research and DevelopmentWhite River Junction Veterans Affairs Medical CenterRecruitingSuicide PreventionUnited States
-
Cedars-Sinai Medical CenterNational Institute on Aging (NIA)Active, not recruitingPolypharmacy | Readmission | Nonadherence, PatientUnited States
-
Ward of the 21st CenturyCanadian Institutes of Health Research (CIHR); Alberta Health services; University...CompletedOther Diagnoses, Comorbidities, and ComplicationsCanada
-
Scripps Whittier Diabetes InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Covid19United States
-
Laval UniversityRecruitingOxygen Deficiency | COPD ExacerbationCanada
-
Parc de Salut MarCompletedChronic Obstructive Pulmonary DiseaseSpain
-
National University Health System, SingaporeNational University of SingaporeCompleted