Care Coordination/Home Telehealth to Safeguard Care in CKD
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 9/26/2018 |
Start Date: | May 2014 |
End Date: | August 2018 |
Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD
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.
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.
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.
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.
Inclusion Criteria:
- Veterans with Stage III-V CKD
- Diabetes
Exclusion Criteria:
- Expectation of dialysis or death within 6 months
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