Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03141905 |
| Other study ID # |
HP-00069775 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 16, 2017 |
| Est. completion date |
October 7, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure
control are well-established in chronic kidney diseases (CKD) patients; however, these agents
may become hazardous on "sick-days" that lead to volume depletion (dehydration), and increase
the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent
significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day
Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication
in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses
if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in
CKD (such as slow renal function loss and AKI episodes) and reduce preventable service
utilization versus usual care.
Description:
Hypothesis: implementing a self managed "Sick-Day Protocol" with telephone monitoring via
interactive voice survey dial-response system (IVSDRS) in CKD patients taking RAS blockers,
diuretics, metformin, or NSAIDs, will safely slow renal function loss, reduce the incidence
of acute kidney injury, and prevent urgent health utilization; in comparison to usual care.
Study Design: 6-month randomized trial of Sick-Day Protocol vs usual care
Randomization: In-block randomization stratified by use (with or without any other qualifying
medication) vs non-use of RAS blocker (with any other qualifying medication)
Intervention: Sick-Day Protocol (instructions for holding and resumption of certain medicines
in the event of dehydrating illness), IVRSDRS remote monitoring, augmented laboratory
monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC)
Study Population: Veterans across the VA Maryland Health Care System (VAMCHS) with a current
prescription for any type of RAS blocker, Diuretic, Metformin or NSAID.
Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research Education and
Clinical Center (GRECC).
Specific Aims 1: Conduct a pragmatic trial comparing the renal function decline, incidence of
AKI, and urgent service utilization in eligible CKD patients provided with a self-managed
Sick-Day Protocol versus comparable patients receiving usual care.Specific Aim 2: Determine
the incidence of sick-days in the intervention arm using remote IVSDRS monitoring and
end-of-study survey of all participants. Specific Aim 3: Evaluate intervention arm
participants' usage of, and adherence to, the Sick-Day Protocol with remote IVSDRS
monitoring.
Study Measurements: laboratory-measured renal function, and patient- reported safety events
obtained per IVSDRS protocol. Emergency department (ED) visits, hospitalization, renal
progression, incidence of ESRD, and death will be measured in both groups along with patient
satisfaction.
Primary outcomes: 6-month change in renal function (eGFR), incidence of AKI episodes
(including ICD-10 code designated, and detectable creatinine-based changes in renal function
usingRIFLE criteria), preventable/urgent service utilization (to be ascertained using VA EHR
review)
Secondary outcomes: Determination of incidence of sick-day events (IVSDRS reporting, and
end-of-study self-report).
Tertiary:Adherence to self-management Sick-Day Protocol (based on IVSDRS reporting)
Analytic plans: Comparison between intervention and usual care participants of 6-month renal
function change, and frequency of AKI and hospitalization using generalized linear models and
Poisson regression methods, respectively. Similar regression methods will be used to
determine the adjusted frequency rate of sick-day incidents and participant response to
sick-days.
Public Health Relevance: Introduction of a self-management Sick-Day Protocol in conjunction
with coordinated care and IVSDRS surveillance can be an innovative strategy to improve renal
outcomes and reduce preventable service utilization.
