Chronic Kidney DiseaseCKD/ESRD-MITNCT01459770
Medication Intervention in Transitional Care to Optimize Outcomes & Costs for CKD & ESRD
A study testing Medication Information Transfer Intervention in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Providence Medical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease
- What is being tested?
- Medication Information Transfer Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Kidney Transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Being tested
- Medication Information Transfer Intervention, Usual care for hospital discharge
- Keywords
- glomerular filtration rate, albuminuria, medical therapy, hospital discharge, hospital readmission, CKD complications, CKD risk factors
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Information Transfer InterventionOther
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 dischargeOther
Patients will receive medication information according to standard practice for discharge of hospitalized patients.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | usual care for hospital discharge:
1. CKD group
2. ESRD group Receives: Other: Usual care for hospital discharge |
| intervention | Active comparator | pharmacist administered medication information transfer intervention
1. CKD group
2. ESRD group Receives: Other: Medication Information Transfer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
CKD status, risk factors and complications
blood pressure, eGFR, urine albumin/creatinine ratio, fasting glucose, HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium.
Measured: 30 and 90 days
ESRD status, risk factors and complications:
blood pressure, fasting glucose,HbA1c (in the diabetic subgroup), lipids, hemoglobin, phosphorus, PTH, serum potassium
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Health Sciences & Services Authority of Spokane County, Providence Sacred Heart Medical Center & Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Katherine R Tuttle, MD, Principal investigator, Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of MedicineCynthia L Corbett, PhD, Principal investigator, Washington State University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459770
- Sponsor's protocol ID
- 1R34DK094016-01
- Other IDs
- R34DK094016-01, RFP # 7
- Acronym
- CKD/ESRD-MIT
- Status last verified
- Apr 2017
- First submitted
- 24 Oct 2011
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27487357
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Intervention in Transitional Care to Optimize Outcomes & Costs in CKD & ESRD
- ClinicalTrials.gov ID
- NCT01459770
- Acronym / sponsor ID
- CKD/ESRD-MIT / 1R34DK094016-01
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- glomerular filtration rate, albuminuria, medical therapy, hospital discharge, hospital readmission, CKD complications, CKD risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Providence Medical Research CenterUniversity, hospital or other
- Collaborators
- Washington State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Health Sciences & Services Authority of Spokane County, Providence Sacred Heart Medical Center & Children's Hospital
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Usual care for hospital dischargeusual care for hospital discharge: 1. CKD group 2. ESRD group |
| intervention | Active comparator | Other: Medication Information Transfer Interventionpharmacist administered medication information transfer intervention 1. CKD group 2. ESRD group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized patients
- > 21 years of age
- Diagnosis of CKD stages 3-5, not treated by dialysis
- Hospitalized patients
- > 21 years of age
Key exclusion criteria (1 listed)
- 1. Kidney Transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Information Transfer InterventionA 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. | Other | intervention |
| Usual care for hospital dischargePatients will receive medication information according to standard practice for discharge of hospitalized patients. | Other | control |
Primary outcome
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.
2 secondary outcomes
CKD status, risk factors and complications
Time frame: 30 and 90 days
ESRD status, risk factors and complications:
Time frame: 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 27487357Alicic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine R Tuttle, MD principal investigator
Providence Sacred Heart Medical Center and Children's Hospital; University of Washington School of Medicine
Cynthia L Corbett, PhD principal investigator
Washington State University College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Information Transfer Intervention in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Providence Medical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute care utilization (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.