An interventional study of Sick-Day Protocol and Usual Care in Safety Issues and Chronic Kidney Diseases, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Health services research
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.
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Exclusion Criteria:
Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVRSDRS weekly remote monitoring
Other: Sick-Day Protocol
Standard clinical care
Other: Usual Care
Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
Standard clinical care
Change in Renal Function From Baseline to Study Completion;
Laboratory measurement of creatinine at study entry and completion
Time frame: 6 months (enrollment to study completion)
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
Time frame: 6 months (enrollment to study completion)
ER Use and Hospitalization
Participants with urgent service utilization including emergency department, hospitalization, and urgent care.
Time frame: 6 months (enrollment to study completion)
Determination of Sick-day Incidents
Participants reporting sick-days via IVSDRS and end-of study visit survey ascertainment.
Time frame: 6 months from enrollment in study
Adherence to the Self-management Sick-day Protocol
Frequency of Sick-Day qualifying illnesses reported. (Note: this outcome is N/A for the usual care group)
Time frame: 6 months (enrollment to study completion)
| Milestone | Sick-Day Protocol | Usual Care |
|---|---|---|
| Started | 176 | 166 |
| Completed | 152 | 147 |
| Not completed | 24 | 19 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 3 | 7 |
| Withdrew: Randomized, but did not receive intervention. withdrew prior to baseline visit. | 17 | 10 |
Laboratory measurement of creatinine at study entry and completion
| mg/dL | Sick-Day Protocol | Usual Care |
|---|---|---|
| Change in Renal Function From Baseline to Study Completion; | 0.01 (-0.11 to 0.22) | 0.02 (-.010 to 0.21) |
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
| Participants | Sick-Day Protocol | Usual Care |
|---|---|---|
| AKI ICD-10 code on ED visit or admission | 4 | 4 |
| 50% increase in Creatinine | 1 | 0 |
Participants with urgent service utilization including emergency department, hospitalization, and urgent care.
| Participants | Sick-Day Protocol | Usual Care |
|---|---|---|
| Hospitalization | 29 | 23 |
| Emergency Room | 35 | 30 |
| Urgent Care | 5 | 5 |
Participants reporting sick-days via IVSDRS and end-of study visit survey ascertainment.
| Participants | Sick-Day Protocol | Usual Care |
|---|---|---|
| Determination of Sick-day Incidents | 29 | 20 |
Frequency of Sick-Day qualifying illnesses reported. (Note: this outcome is N/A for the usual care group)
| count of qualifying illnesses | Sick-Day Protocol |
|---|---|
| Followed Sick-Day Protocol instructions | 14 |
| Did not stop medicines | 12 |
| Stopped other medicines in addition to SDP qualifying. | 6 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sick-Day Protocol | 3/159 (1.9%) | 0/159 (0%) | 7/159 (4.4%) |
| Usual Care | 2/156 (1.3%) | 0/156 (0%) | 3/156 (1.9%) |
| Event | Sick-Day Protocol | Usual Care |
|---|---|---|
| Lab Alert: Potassium ≥ 6.1 mEq/dLCardiac disorders | 3/159 | 1/156 |
| Lab Alert: Glucose ≥ 499 mg/dLEndocrine disorders | 1/159 | 2/156 |
| Lab Alert: Chloride ≥ 115 mEq/dLRenal and urinary disorders | 2/159 | 0/156 |
| Initiation of HemodialysisRenal and urinary disorders | 1/159 | 1/156 |
| Lab Alert: Hemoglobin ≤ 7.5 g/dLBlood and lymphatic system disorders | 1/159 | 0/156 |
| Lab Alert: Co2 ≤ 15 mEq/LRenal and urinary disorders | 1/159 | 0/156 |
| Age, Categorical(Participants) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 37 | 66 |
| >=65 years | 130 | 119 | 249 |
| Sex: Female, Male(Participants) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 152 | 149 | 301 |
| Ethnicity (NIH/OMB)(Participants) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 158 | 155 | 313 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 100 | 99 | 199 |
| White | 58 | 56 | 114 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| United States | 159 | 156 | 315 |
| eGFR(ml/min/1.73m^2) | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|
| Mean | 43.110 ± 13.128 | 43.783 ± 13.018 | 43.441 ± 13.057 |
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University of Maryland, Baltimore