Care Coordination/Home Telehealth to Safeguard Care in CKD (CCHT in CKD)
Primary Purpose
Safety Issues, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCHT
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Safety Issues focused on measuring chronic kidney disease, patient safety, home telehealth
Eligibility Criteria
Inclusion Criteria:
- Veterans with Stage III-V CKD
- Diabetes
Exclusion Criteria:
- Expectation of dialysis or death within 6 months
Sites / Locations
- Baltimore VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CCHT
Usual care
Arm Description
Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
Outcomes
Primary Outcome Measures
Safety Events
number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)
Secondary Outcome Measures
Change in Renal Function
Change in GFR from baseline to 6 months
Hospitalization
Frequency of unanticipated hospitalization events over duration of study
Full Information
NCT ID
NCT03038126
First Posted
January 29, 2017
Last Updated
March 4, 2020
Sponsor
University of Maryland, Baltimore
Collaborators
Baltimore VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03038126
Brief Title
Care Coordination/Home Telehealth to Safeguard Care in CKD
Acronym
CCHT in CKD
Official Title
Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Baltimore VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Home telehealth monitoring of veterans with chronic kidney disease, with a disease management protocol and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for urgent health resource utilization and associated poor outcomes.
Detailed Description
Pre-dialysis chronic kidney disease (CKD) is associated with a high risk of harm related to medical care (adverse safety events). These events may occur outside the purview of the medical system, and hence, are under-recognized. Health information technology (IT) can enhance the detection of such events, and coordinated care can prevent their adverse consequences. Study design: 6-month randomized trial of coordinated care/home telehealth (CCHT) vs usual care in CKD patients. Intervention: Veterans Administration (VA) CCHT with a guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC). Study population: Veterans with Stage III-V CKD (no expected dialysis within 6 months), age ≥ 60 years old, and diabetes (n = 65 per arm). Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research, Education and Clinical Center (GRECC), and RISC. Specific Aim 1: Compare detection of adverse safety events in CKD patients assigned to CCHT vs usual care. Specific Aim 2: Compare the frequency of urgent health service use and participant satisfaction with CCHT vs usual care group. Study Measurements: Vital sign and clinical measurements (daily BP, weight, and finger stick glucose), laboratory values, and patient- reported safety events obtained per CCHT protocol vs patient-reported safety events, laboratory values, and assessment at a mid-study safety clinic visit in usual care protocol. Emergency department (ED) visits, hospitalization, renal progression, incidence of ESRD, and death will be measured in both groups along with patient satisfaction. Outcomes: Aim 1: Counts of a diverse set of adverse safety events including hypoglycemia, hypotension, volume loss (by weight change), hyperkalemia, acute kidney injury (AKI), and patient-reported safety incidents. Aim 2: ED visits, hospitalization, and other adverse outcomes including renal function loss, ESRD, and death. Analytic plans: Adjusted rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in CCHT vs usual care group with multivariate models as indicated. Expected findings: CCHT will increase the detection of adverse safety events but reduce urgent health resource utilization and adverse outcomes. Public Health Relevance: Home telemonitoring of CKD patients in conjunction with coordinated care and decision support can increase the detection of adverse safety events that occur outside the traditional health care system and offer new opportunities to reduce their associated poor outcomes on a platform that allows ready dissemination across a national health network.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Chronic Kidney Disease
Keywords
chronic kidney disease, patient safety, home telehealth
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCHT
Arm Type
Active Comparator
Arm Description
Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
Arm Title
Usual care
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
CCHT
Intervention Description
Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Standard clinical care
Primary Outcome Measure Information:
Title
Safety Events
Description
number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in Renal Function
Description
Change in GFR from baseline to 6 months
Time Frame
6 months
Title
Hospitalization
Description
Frequency of unanticipated hospitalization events over duration of study
Time Frame
3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veterans with Stage III-V CKD
Diabetes
Exclusion Criteria:
Expectation of dialysis or death within 6 months
Facility Information:
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Links:
URL
http://projectreporter.nih.gov/project_info_description.cfm?aid=8856231&icde=31902332&ddparam=&ddvalue=&ddsub=&cr=3&csb=default&cs=ASC
Description
NIH Reporter study entry
Learn more about this trial
Care Coordination/Home Telehealth to Safeguard Care in CKD
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