Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03141905|
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues Chronic Kidney Diseases||Other: Sick-Day Protocol Other: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2022|
|Active Comparator: Sick-Day Protocol||
Other: Sick-Day Protocol
Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
|Placebo Comparator: Usual Care||
Other: Usual Care
Standard clinical care
- Change in renal function from baseline to study completion; [ Time Frame: 6 months (enrollment to study completion) ]Laboratory measurement of creatinine at study entry and completion
- Acute kidney injury incidents [ Time Frame: 6 months (enrollment to study completion) ]Abrupt changes in renal function as determined by EHR post-study review of new AKI ICD-10 codes, and for-cause lab ambulatory lab testing using RIFLE criteria
- ER use and hospitalization [ Time Frame: 6 months (enrollment to study completion) ]Urgent service utilization
- Determination of sick-day incidents [ Time Frame: 6 months from enrollment in study ]IVSDRS recording of sick-days and participant reporting at end-of study
- Adherence to the self-management sick-day protocol [ Time Frame: 6 months (enrollment to study completion) ]Frequency of expected and actual indicators of proper sick-day protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141905
|Contact: Jeffrey C Fink, MDfirstname.lastname@example.org|
|Contact: Rebecca M Doerfler, MPHemail@example.com|
|United States, Maryland|
|Baltimore VA Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Jeffrey C Fink, MD|
|Principal Investigator: Jeffrey C Fink, MD|
|Sub-Investigator: Stephen Seliger, MD|