Safety IssuesNCT03141905
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
A study testing Sick-Day Protocol in people with Safety Issues and Chronic Kidney Diseases, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Issues, Chronic Kidney Diseases
- What is being tested?
- Sick-Day Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 7 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID
Who cannot join
- Expected death or dialysis within 6 months
- No home or cellular telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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
- Being tested
- Sick-Day Protocol, Usual Care
- Keywords
- patient safety, self-management, remote monitoring
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sick-Day ProtocolOther
Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
Usual CareOther
Standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| Sick-Day Protocol | Active comparator | Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVRSDRS weekly remote monitoring Receives: Other: Sick-Day Protocol |
| Usual Care | Placebo comparator | Standard clinical care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Renal Function From Baseline to Study Completion;
Laboratory measurement of creatinine at study entry and completion
Measured: 6 months (enrollment to study completion)
Secondary outcomes (2)
Acute Kidney Injury Incidents
Participants with 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
Measured: 6 months (enrollment to study completion)
ER Use and Hospitalization
Participants with urgent service utilization including emergency department, hospitalization, and urgent care.
Measured: 6 months (enrollment to study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start16 Oct 2017
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Fink, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141905
- Sponsor's protocol ID
- HP-00069775
- Status last verified
- Mar 2021
- First submitted
- 3 May 2017
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36046613
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT03141905
- Acronym / sponsor ID
- HP-00069775
- Conditions
- Safety Issues, Chronic Kidney Diseases
- Keywords
- patient safety, self-management, remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sick-Day Protocol | Active comparator | Other: Sick-Day ProtocolSick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVRSDRS weekly remote monitoring |
| Usual Care | Placebo comparator | Other: Usual CareStandard clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID
Key exclusion criteria (2 listed)
- Expected death or dialysis within 6 months
- No home or cellular telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sick-Day ProtocolSick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring | Other | Sick-Day Protocol |
| Usual CareStandard clinical care | Other | Usual Care |
Primary outcome
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
2 secondary outcomes
Acute Kidney Injury Incidents
Time frame: 6 months (enrollment to study completion)
ER Use and Hospitalization
Time frame: 6 months (enrollment to study completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36046613Fink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sick-Day Protocol in people with Safety Issues and Chronic Kidney Diseases, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Renal Function From Baseline to Study Completion; (time frame: 6 months (enrollment to study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.