Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease

NCT ID: NCT03141905

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2020-10-07

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 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.

Conditions

Safety Issues; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Sick-Day Protocol

Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVRSDRS weekly remote monitoring

Group Type: ACTIVE_COMPARATOR

Sick-Day Protocol

Intervention Type: OTHER

Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring

Usual Care

Standard clinical care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

Standard clinical care

Interventions

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

Intervention Type: OTHER

Usual Care

Standard clinical care

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Fink

Division Head, General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baltimore VA Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Fink JC, Maguire RM, Blakeman T, Tomlinson LA, Tomson C, Wagner LA, Zhan M. Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol. Kidney Med. 2022 Jul 31;4(9):100527. doi: 10.1016/j.xkme.2022.100527. eCollection 2022 Sep.

Reference Type: DERIVED

PMID: 36046613 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00069775

Identifier Type: -

Identifier Source: org_study_id