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. Hypothesis: Home telehealth monitoring of CKD patients, with a disease management protocol (DMP) 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. 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 e 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.
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. This project investigates an intervention using home-based telehealth in conjunction with coordinated care and decision support. Its goal is to increase the detection of adverse safety incidents in CKD outside the boundaries of the health care system, and improve the poor outcomes characteristic of this disease.