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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 : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey Fink, University of Maryland

May 3, 2017
May 5, 2017
October 25, 2017
October 16, 2017
July 2019   (Final data collection date for primary outcome measure)
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
Change in renal function from baseline to study completion; [ Time Frame: 6 months ]
Laboratory measurement of creatinine at study entry and completion
Complete list of historical versions of study NCT03141905 on ClinicalTrials.gov Archive Site
  • 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
  • Acute kidney injury incidents [ Time Frame: 6 months ]
    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 ]
    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
  • Determination of sick-day incidents [ Time Frame: 6 months ]
    IVSDRS recording of sick-days and participant reporting at end-of study
  • Adherence to the self-management sick-day protocol [ Time Frame: 6 months ]
    Frequency of expected and actual indicators of proper sick-day protocol
 
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Safety Issues
  • Chronic Kidney Diseases
  • 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
  • Other: Usual Care
    Standard clinical care
  • Active Comparator: Sick-Day Protocol
    Intervention: Other: Sick-Day Protocol
  • Placebo Comparator: Usual Care
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
Same as current
July 2022
July 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID

Exclusion Criteria:

  • Expected death or dialysis within 6 months
  • No home or cellular telephone
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Jeffrey C Fink, MD 410-605-7117 jfink@som.umaryland.edu
Contact: Rebecca M Doerfler, MPH 410-605-7117 rdoerfler@som.umaryland.edu
United States
 
 
NCT03141905
HP-00069775
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Jeffrey Fink, University of Maryland
University of Maryland
Not Provided
Not Provided
University of Maryland
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP