Care Coordination/Home Telehealth to Safeguard Care in CKD

Chronic Kidney Disease Clinical Trial

— CCHT in CKD  

Official title:

Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038126
• Other study ID #: HP-00058634
• Secondary ID: R34DK102177
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: August 2018

Study information

• Verified date: March 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Veterans with Stage III-V CKD

• Diabetes

Exclusion Criteria:

• Expectation of dialysis or death within 6 months

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Safety Issues

Intervention

Other:
• CCHT
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).
• Usual care
Standard clinical care

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Baltimore VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	3 months, 6 months
Secondary	Change in Renal Function	Change in GFR from baseline to 6 months	6 months
Secondary	Hospitalization	Frequency of unanticipated hospitalization events over duration of study	3 months, 6 months

External Links

•   NIH Reporter study entry