Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03141905
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):
Jeffrey Fink, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Safety Issues Chronic Kidney Diseases Other: Sick-Day Protocol Other: Usual Care Not Applicable

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 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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. ER use and hospitalization [ Time Frame: 6 months (enrollment to study completion) ]
    Urgent service utilization

Other Outcome Measures:
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03141905

Contact: Jeffrey C Fink, MD 410-605-7117
Contact: Rebecca M Doerfler, MPH 410-605-7117

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         
Sponsors and Collaborators
University of Maryland

Additional Information:
Responsible Party: Jeffrey Fink, Division Head, General Internal Medicine, University of Maryland Identifier: NCT03141905     History of Changes
Other Study ID Numbers: HP-00069775
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Fink, University of Maryland:
patient safety
remote monitoring

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency