Chronic Kidney Disease, Safety Issues
Conditions
Keywords
chronic kidney disease, patient safety, home telehealth
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.
Interventions
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).
Standard clinical care
Sponsors
Study design
Eligibility
Inclusion criteria
* Veterans with Stage III-V CKD * Diabetes
Exclusion criteria
* Expectation of dialysis or death within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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). | 63 |
| Usual Care Usual care: Standard clinical care | 55 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Long Term Hospitalization | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Too Ill to Participate | 1 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | CCHT | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 70.9 year STANDARD_DEVIATION 5.4 | 70.7 year STANDARD_DEVIATION 6.2 | 70.8 year STANDARD_DEVIATION 5.8 |
| eGFR | 42.5 ml/min/1.73m2 STANDARD_DEVIATION 12.7 | 42.4 ml/min/1.73m2 STANDARD_DEVIATION 13.9 | 42.5 ml/min/1.73m2 STANDARD_DEVIATION 13.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 36 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 17 Participants | 41 Participants |
| Region of Enrollment United States | 63 participants | 55 participants | 118 participants |
| Sex: Female, Male Female | 61 Participants | 53 Participants | 114 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 63 | 1 / 55 |
| other Total, other adverse events | 49 / 63 | 51 / 55 |
| serious Total, serious adverse events | 0 / 63 | 0 / 55 |
Outcome results
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.)
Time frame: 3 months, 6 months
Population: number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CCHT | Safety Events | Self-Reported Safety Events (3 months) | 70 safety events |
| CCHT | Safety Events | Self-Reported Safety Events (6 months) | 61 safety events |
| CCHT | Safety Events | In-Center Safety Events (3 months) | 30 safety events |
| CCHT | Safety Events | In-Center Safety Events (6 months) | 26 safety events |
| Usual Care | Safety Events | In-Center Safety Events (6 months) | 28 safety events |
| Usual Care | Safety Events | Self-Reported Safety Events (3 months) | 54 safety events |
| Usual Care | Safety Events | In-Center Safety Events (3 months) | 30 safety events |
| Usual Care | Safety Events | Self-Reported Safety Events (6 months) | 58 safety events |
Change in Renal Function
Change in GFR from baseline to 6 months
Time frame: 6 months
Population: number analyzed differs from total population due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CCHT | Change in Renal Function | -0.36 ml/min/1.73m2 | Standard Deviation 6.44 |
| Usual Care | Change in Renal Function | -3.19 ml/min/1.73m2 | Standard Deviation 9.44 |
Hospitalization
Frequency of unanticipated hospitalization events over duration of study
Time frame: 3 months, 6 months
Population: number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CCHT | Hospitalization | Reported at 3 month visit | 0.11 hospitalizaztions per month |
| CCHT | Hospitalization | Reported at 6 month visit | 0.11 hospitalizaztions per month |
| Usual Care | Hospitalization | Reported at 3 month visit | 0.14 hospitalizaztions per month |
| Usual Care | Hospitalization | Reported at 6 month visit | 0.15 hospitalizaztions per month |