Care Coordination/Home Telehealth to Safeguard Care in CKD

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Safety Issues
• Interventions: Other: Usual care; Other: CCHT

• Registration Number: NCT03038126
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-29
• Study First Posted: 2017-01-31
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-10-08
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Results First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Veterans with Stage III-V CKD
• Diabetes

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Exclusion Criteria

• Expectation of dialysis or death within 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	-
CCHT	CCHT	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).

Primary Outcome Measures

Name	Time	Method
Safety Events	3 months, 6 months	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

Name	Time	Method
Change in Renal Function	6 months	Change in GFR from baseline to 6 months
Hospitalization	3 months, 6 months	Frequency of unanticipated hospitalization events over duration of study

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States