Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-04 @ 9:55 PM
Study NCT ID:
NCT03832595
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2019-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Kidney Coordinated Health Management Partnership
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': 'jhambm@upmc.edu', 'phone': '4126477062', 'title': 'Dr. Manisha Jhamb', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Lower duration of follow-up period due to COVID-19 pandemic related delays'}}, 'adverseEventsModule': {'timeFrame': 'Over the entire study follow-up period, median follow-up 17 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology).", 'otherNumAtRisk': 754, 'deathsNumAtRisk': 754, 'otherNumAffected': 59, 'seriousNumAtRisk': 754, 'deathsNumAffected': 142, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).', 'otherNumAtRisk': 842, 'deathsNumAtRisk': 842, 'otherNumAffected': 77, 'seriousNumAtRisk': 842, 'deathsNumAffected': 130, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L)', 'notes': 'Electrolytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 754, 'numEvents': 87, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 842, 'numEvents': 107, 'numAffected': 77}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Severe Hyperkalemia', 'notes': 'Electrolytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 754, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 842, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '12.7'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '14.1'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.38', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01'}], 'paramType': 'NUMBER', 'timeFrame': 'Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). Cumulative % at 24 months reported', 'description': 'The outcome measure is occurrence of renal failure event and is defined as a greater than or equal to 40% decline in eGFR or occurrence of End Stage Renal Disease. The 40% decline in renal failure is a well accepted endpoint for renal failure in clinical trials and is approved by the FDA.\n\neGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice. All eGFR values within 6-month windows will be averaged to account for ascertainment bias, and analyzed using discrete-time survival approach using generalized linear mixed model.\n\nESRD will be defined as an eGFR less than or equal to 10ml/min, or starting of renal replacement therapy (dialysis or kidney transplant)', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice'}, {'type': 'SECONDARY', 'title': 'Hypertension (HTN) Control Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}, {'units': 'Primary care practices', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000', 'lowerLimit': '-0.002', 'upperLimit': '0.024'}, {'value': '0.0005', 'groupId': 'OG001', 'lowerLimit': '-0.012', 'upperLimit': '0.013'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.008', 'ciUpperLimit': '0.029', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'α = 0.05'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'HTN control is defined as achieved BP\\<140/90mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control', 'unitOfMeasure': 'log-odds per month slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practices', 'denomUnitsSelected': 'Primary care practices'}, {'type': 'SECONDARY', 'title': 'Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '196.8', 'groupId': 'OG000', 'lowerLimit': '174.9', 'upperLimit': '219.0'}, {'value': '163.1', 'groupId': 'OG001', 'lowerLimit': '146.3', 'upperLimit': '179.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.43', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'α = 0.05'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm', 'unitOfMeasure': 'exposure days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice'}, {'type': 'SECONDARY', 'title': 'Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '8.0'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '9.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.25', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'α = 0.05'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients", 'unitOfMeasure': 'exposure days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice'}, {'type': 'SECONDARY', 'title': 'Medication Safety: Glyburide Exposure Days Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '8.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '5.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.03', 'ciUpperLimit': '53.78', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'α = 0.05'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis - Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period(max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm\n\nGlyburide use will be examined for all study patients with diabetes at baseline", 'unitOfMeasure': 'exposure days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice'}, {'type': 'SECONDARY', 'title': 'Medication Safety: Metformin Exposure Days Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '42.2'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '33.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.12', 'ciUpperLimit': '9.96', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'α = 0.05'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30", 'unitOfMeasure': 'exposure days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice'}, {'type': 'SECONDARY', 'title': 'Medication Safety: Gemfibrozil Exposure Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Primary care practice', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'timeFrame': 'Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months)', 'description': 'We will examine the rate of use of gemfibrozil among those with eGFR\\<30 at baseline', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care practice', 'denomUnitsSelected': 'Primary care practice', 'populationDescription': 'Although Gemfibrozil was a pre-specified secondary outcome, it was excluded from analyses since among those with eGFR\\<30 at baseline, active use was found only in 1 patient control arm) and there is no statistically meaningful way of analyzing this'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}, {'id': 'OG001', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}], 'classes': [{'categories': [{'measurements': [{'value': '177.5', 'groupId': 'OG000', 'lowerLimit': '146.2', 'upperLimit': '208.8'}, {'value': '222.5', 'groupId': 'OG001', 'lowerLimit': '182.9', 'upperLimit': '262.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'Outcome 3 will be repeated in the subgroup of participants receiving RAASi who have macroalbuminuria, RAASi use will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).', 'unitOfMeasure': 'medication exposure days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hypertension (HTN) Control for Achieved BP <130/80 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.086', 'groupId': 'OG000', 'lowerLimit': '0.073', 'upperLimit': '0.100'}, {'value': '0.079', 'groupId': 'OG001', 'lowerLimit': '0.066', 'upperLimit': '0.092'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'HTN control is defined as achieved BP\\<130/80mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control', 'unitOfMeasure': 'log-odds per month slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'These are patients who were eligible at initial screening', 'achievements': [{'groupId': 'FG000', 'numUnits': '48', 'numSubjects': '754'}, {'groupId': 'FG001', 'numUnits': '50', 'numSubjects': '842'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '48', 'numSubjects': '575'}, {'groupId': 'FG001', 'numUnits': '50', 'numSubjects': '711'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '179'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '131'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Medical management without dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Primary care practices', 'preAssignmentDetails': '18,157 participants from 101 practices underwent initial screening. Out of these 1,803 from 9 practices were eligible at initial screening, which included 874 (from 50 practices) in control arm, and 929 (from 4 practices) in intervention arm.\n\nPatients who had confirmed eligibility after initial screening and had a PCP appointment within 1 year of eligibility screening were enrolled. In intervention group, patients or PCPs who opted-out at this stage were not enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'BG000'}, {'value': '842', 'groupId': 'BG001'}, {'value': '1596', 'groupId': 'BG002'}]}, {'units': 'Primary care practice', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': "Patients will receive a care bundle\n\nEHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).\n\nUsual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '73.6', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '928', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '323', 'groupId': 'BG001'}, {'value': '668', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '748', 'groupId': 'BG000'}, {'value': '831', 'groupId': 'BG001'}, {'value': '1579', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '696', 'groupId': 'BG000'}, {'value': '753', 'groupId': 'BG001'}, {'value': '1449', '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': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '754', 'groupId': 'BG000'}, {'value': '842', 'groupId': 'BG001'}, {'value': '1596', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '131.1', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '131.6', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '131.4', 'spread': '16.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '74.1', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Serum Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'eGFR CKD-EPI', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Urine Albumin-creatinine ratio', 'classes': [{'categories': [{'measurements': [{'value': '86.0', 'groupId': 'BG000', 'lowerLimit': '16.3', 'upperLimit': '434.0'}, {'value': '84.6', 'groupId': 'BG001', 'lowerLimit': '14.0', 'upperLimit': '410.3'}, {'value': '85.0', 'groupId': 'BG002', 'lowerLimit': '15.1', 'upperLimit': '421.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'UACR mg/g', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Primary care practice'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-01', 'size': 918707, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-18T10:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcomes are ascertained by data programmers who are blinded to study arm assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1596}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2023-05-10', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2019-01-30', 'resultsFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2019-02-04', 'dispFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-20', 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'Outcome 3 will be repeated in the subgroup of participants receiving RAASi who have macroalbuminuria, RAASi use will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).'}, {'measure': 'Hypertension (HTN) Control for Achieved BP <130/80 mm Hg', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'HTN control is defined as achieved BP\\<130/80mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control'}], 'primaryOutcomes': [{'measure': 'Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD)', 'timeFrame': 'Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). Cumulative % at 24 months reported', 'description': 'The outcome measure is occurrence of renal failure event and is defined as a greater than or equal to 40% decline in eGFR or occurrence of End Stage Renal Disease. The 40% decline in renal failure is a well accepted endpoint for renal failure in clinical trials and is approved by the FDA.\n\neGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice. All eGFR values within 6-month windows will be averaged to account for ascertainment bias, and analyzed using discrete-time survival approach using generalized linear mixed model.\n\nESRD will be defined as an eGFR less than or equal to 10ml/min, or starting of renal replacement therapy (dialysis or kidney transplant)'}], 'secondaryOutcomes': [{'measure': 'Hypertension (HTN) Control Outcome', 'timeFrame': 'Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'HTN control is defined as achieved BP\\<140/90mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control'}, {'measure': 'Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': 'Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm'}, {'measure': 'Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients"}, {'measure': 'Medication Safety: Glyburide Exposure Days Per Year', 'timeFrame': 'Time to event analysis - Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period(max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm\n\nGlyburide use will be examined for all study patients with diabetes at baseline"}, {'measure': 'Medication Safety: Metformin Exposure Days Per Year', 'timeFrame': 'Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)', 'description': "Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30"}, {'measure': 'Medication Safety: Gemfibrozil Exposure Days', 'timeFrame': 'Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months)', 'description': 'We will examine the rate of use of gemfibrozil among those with eGFR\\<30 at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electronic health record', 'population health management', 'patient education', 'medication therapy management', 'electronic consultation', 'randomized controlled trial', 'pragmatic trial'], 'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '37348600', 'type': 'BACKGROUND', 'citation': 'Jhamb M, Weltman MR, Yabes JG, Kamat S, Devaraj SM, Fischer GS, Rollman BL, Nolin TD, Abdel-Kader K. Electronic health record based population health management to optimize care in CKD: Design of the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) trial. Contemp Clin Trials. 2023 Aug;131:107269. doi: 10.1016/j.cct.2023.107269. Epub 2023 Jun 20.'}, {'pmid': '38619824', 'type': 'DERIVED', 'citation': 'Jhamb M, Weltman MR, Devaraj SM, Lavenburg LU, Han Z, Alghwiri AA, Fischer GS, Rollman BL, Nolin TD, Yabes JG. Electronic Health Record Population Health Management for Chronic Kidney Disease Care: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):737-747. doi: 10.1001/jamainternmed.2024.0708.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37348600/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention that targets improvements in the delivery of evidence-based CKD care.', 'detailedDescription': 'To test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention to improve the delivery of evidence-based Chronic Kidney Disease (CKD) care in patients with high-risk CKD. Investigators will perform a 42-month pragmatic, cluster randomized (at the practice level) controlled trial in 1,650 patients with high-risk CKD (as defined by validated risk prediction models or by current estimated Glomerular Filtration Rate (eGFR) value or recent decline in eGFR values) managed by their Primary Care Physicians (PCPs) to determine whether EHR-based PHM improves key processes of care and clinical outcomes.\n\nThe investigators hypothesize that EHR-based PHM will improve hypertension control, use of renin angiotensin aldosterone system inhibitors (RAASi), and avoidance of renally contraindicated medications (Aim 1a-1c) and delay CKD progression (Aim 2).\n\nInvestigators will also characterize the acceptability and experience of Primary Care Physicians (PCPs) in the intervention arm of the CKD PHM study (Aim 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University of Pittsburgh Medical Center (UPMC) community medicine practice.\n\nInclusion criteria for patients:\n\n1. age greater than or equal to 18, and less than or equal to 85\n2. most recent eGFR less than 60 ml/min/yr\n3. established care with UPMC PCP\n4. high risk CKD based on validated external and internal risk prediction models or severe reduction in eGFR, or substantial loss in eGFR in prior 18 months.\n\nExclusion Criteria for PCPs: none\n\nExclusion Criteria for patients:\n\n1. history of kidney transplant\n2. receiving maintenance dialysis\n3. recent (within 12 months) outpatient nephrology visit\n4. baseline eGFR less than 15ml/min\n5. expected survival less than 6 months or hospice enrollee (e.g., stage IV heart failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)'}, 'identificationModule': {'nctId': 'NCT03832595', 'acronym': 'Kidney-CHAMP', 'briefTitle': 'Kidney Coordinated Health Management Partnership', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Kidney Coordinated Health Management Partnership', 'orgStudyIdInfo': {'id': 'STUDY19060280'}, 'secondaryIdInfos': [{'id': 'R18DK118460', 'link': 'https://reporter.nih.gov/quickSearch/R18DK118460', 'type': 'NIH'}, {'id': '1R01DK116957-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK116957-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Patients will receive a care bundle', 'interventionNames': ['Other: EHR-based PHM']}], 'interventions': [{'name': 'EHR-based PHM', 'type': 'OTHER', 'description': "An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:\n\n1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \\~6 months,\n2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \\~6 months,\n3. and Nurse led CKD patient education, every \\~6-12 months\n\nunless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology).", 'armGroupLabels': ['Intervention Arm']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Khaled Abdel-Kader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Manisha Jhamb, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manisha Jhamb', 'investigatorAffiliation': 'University of Pittsburgh'}}}}