Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03141905
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2017-05-03
Brief Title:
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 careSpecific 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 preventableurgent 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
TertiaryAdherence 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
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 careSpecific 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 preventableurgent 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
TertiaryAdherence 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None