Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-04-15 @ 4:56 AM
Study NCT ID:
NCT03141905
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfink@som.umaryland.edu', 'phone': '410-328-4822', 'title': 'Jeffrey C. Fink MD, MS (Principal Investigator)', 'organization': 'University of Maryland, Baltimore'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the COVID-19 pandemic in-person visits were suspended on 3/12/2020 per institution and IRB mandate. Study lab measurements were delayed for 24 participants and not completed for 8 participants.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sick-Day Protocol', 'description': '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', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 7, 'seriousNumAtRisk': 159, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 3, 'seriousNumAtRisk': 156, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Initiation of Hemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lab Alert: Glucose ≥ 499 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lab Alert: Potassium ≥ 6.1 mEq/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lab Alert: Hemoglobin ≤ 7.5 g/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lab Alert: Chloride ≥ 115 mEq/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lab Alert: Co2 ≤ 15 mEq/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Renal Function From Baseline to Study Completion;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.22'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-.010', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Laboratory measurement of creatinine at study entry and completion', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '280 participants with complete laboratory data collection'}, {'type': 'SECONDARY', 'title': 'Acute Kidney Injury Incidents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}], 'classes': [{'title': 'AKI ICD-10 code on ED visit or admission', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '50% increase in Creatinine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months (enrollment to study completion)', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ER Use and Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}], 'classes': [{'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Room', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Urgent Care', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Participants with urgent service utilization including emergency department, hospitalization, and urgent care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Determination of Sick-day Incidents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months from enrollment in study', 'description': 'Participants reporting sick-days via IVSDRS and end-of study visit survey ascertainment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '299 participants who completed all study visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adherence to the Self-management Sick-day Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sick-Day Protocol', 'description': 'Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring'}], 'classes': [{'title': 'Followed Sick-Day Protocol instructions', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Did not stop medicines', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Stopped other medicines in addition to SDP qualifying.', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Frequency of Sick-Day qualifying illnesses reported. (Note: this outcome is N/A for the usual care group)', 'unitOfMeasure': 'count of qualifying illnesses', 'reportingStatus': 'POSTED', 'populationDescription': 'Sick-Day Protocol group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Randomized, but did not receive intervention. Withdrew prior to baseline visit.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sick-Day Protocol', 'description': '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'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Usual Care: Standard clinical care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'eGFR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.110', 'spread': '13.128', 'groupId': 'BG000'}, {'value': '43.783', 'spread': '13.018', 'groupId': 'BG001'}, {'value': '43.441', 'spread': '13.057', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline creatinine/eGFR missing for 4 study participants, 3 in the usual care arm, and 1 in the intervention arm.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-21', 'size': 239713, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-21T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2017-05-03', 'resultsFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-12', 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determination of Sick-day Incidents', 'timeFrame': '6 months from enrollment in study', 'description': 'Participants reporting sick-days via IVSDRS and end-of study visit survey ascertainment.'}, {'measure': 'Adherence to the Self-management Sick-day Protocol', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Frequency of Sick-Day qualifying illnesses reported. (Note: this outcome is N/A for the usual care group)'}], 'primaryOutcomes': [{'measure': 'Change in Renal Function From Baseline to Study Completion;', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Laboratory measurement of creatinine at study entry and completion'}], 'secondaryOutcomes': [{'measure': 'Acute Kidney Injury Incidents', 'timeFrame': '6 months (enrollment to study completion)', 'description': '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'}, {'measure': 'ER Use and Hospitalization', 'timeFrame': '6 months (enrollment to study completion)', 'description': 'Participants with urgent service utilization including emergency department, hospitalization, and urgent care.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient safety', 'self-management', 'remote monitoring'], 'conditions': ['Safety Issues', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '36046613', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy Design: 6-month randomized trial of Sick-Day Protocol vs usual care\n\nRandomization: In-block randomization stratified by use (with or without any other qualifying medication) vs non-use of RAS blocker (with any other qualifying medication)\n\nIntervention: 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)\n\nStudy Population: Veterans across the VA Maryland Health Care System (VAMCHS) with a current prescription for any type of RAS blocker, Diuretic, Metformin or NSAID.\n\nStudy Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research Education and Clinical Center (GRECC).\n\nSpecific 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.\n\nStudy 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.\n\nPrimary 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)\n\nSecondary outcomes: Determination of incidence of sick-day events (IVSDRS reporting, and end-of-study self-report).\n\nTertiary:Adherence to self-management Sick-Day Protocol (based on IVSDRS reporting)\n\nAnalytic 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.\n\nPublic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID\n\nExclusion Criteria:\n\n* Expected death or dialysis within 6 months\n* No home or cellular telephone'}, 'identificationModule': {'nctId': 'NCT03141905', 'briefTitle': 'Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?', 'orgStudyIdInfo': {'id': 'HP-00069775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sick-Day Protocol', 'description': 'Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVRSDRS weekly remote monitoring', 'interventionNames': ['Other: Sick-Day Protocol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': 'Standard clinical care', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Sick-Day Protocol', 'type': 'OTHER', 'description': 'Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring', 'armGroupLabels': ['Sick-Day Protocol']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Standard clinical care', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Head, General Internal Medicine', 'investigatorFullName': 'Jeffrey Fink', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}