Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04514458
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tariq.ahmad@yale.edu', 'phone': '203-843-1667', 'title': 'Tariq Ahmad', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations include being conducted at a single health system, that it primarily examined an increase in medication initiation rather than up-titration of dosing, that the alert has only been created and used in the Epic EHR framework, and that the alert was tested during a time when there were coordinated and intensive efforts across the study site to improve medical therapy for heart failure, which is reflected by increases in HFrEF therapies in the usual care arm of the study.'}}, 'adverseEventsModule': {'timeFrame': 'One year', 'description': 'Adverse events are reported to the IRB via written report within 5 calendar days of the Principal Investigator becoming aware of the event.\n\nAdverse events reporting is only described for patient subjects as the exposure of interest would be expected to affect this study population. Adverse events were not monitored or assessed for provider subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.", 'otherNumAtRisk': 685, 'deathsNumAtRisk': 685, 'otherNumAffected': 0, 'seriousNumAtRisk': 685, 'deathsNumAffected': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.', 'otherNumAtRisk': 625, 'deathsNumAtRisk': 625, 'otherNumAffected': 0, 'seriousNumAtRisk': 625, 'deathsNumAffected': 68, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed in patient subjects only.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on Beta Blockers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '606', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with prescribed beta blockers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on ACE Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ACEi', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on ARBs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ARB', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on ARNIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ARNI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on MRAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed MRA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients on SGLT2 Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed SGLT2i', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of One-year All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization', 'description': 'Assessed as the number of patients who expired from randomization up to one year from any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of 30-day Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization', 'description': 'Number of participants with a hospitalization within 30 days of randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of 30-day All-cause Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization', 'description': 'Number of participants with an emergency department visit within 30 days of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Six-month Healthcare Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed from the date of randomization to 6 months post-randomization', 'description': 'Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.', 'reportingStatus': 'POSTED', 'populationDescription': 'The data necessary to analyze this outcome was unable to be released from the university analytics team, therefore we cannot report cost results. The Finance Administration at Yale did not grant approval for access to this data. The data was not collected and will not be accessed in the future.'}, {'type': 'SECONDARY', 'title': 'Percentage of Filled Prescriptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed 6 months post-randomization', 'description': 'Proportion of prescriptions filled as assessed by SureScripts', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed Beta Blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed ACEi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed ARB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed ARNI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}, {'type': 'SECONDARY', 'title': 'Medication Dose of Any Prescribed SGLT2 Inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'timeFrame': 'Assessed at 6 months post-randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'Surescripts data is inaccurate and does not capture all patient prescription fills, thus this data cannot currently be obtained.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '735'}, {'groupId': 'FG001', 'numSubjects': '675'}]}, {'type': 'Patient Subjects Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '685'}, {'groupId': 'FG001', 'numSubjects': '625'}]}, {'type': 'Provider Subjects Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '731'}, {'groupId': 'FG001', 'numSubjects': '672'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "100 providers were identified and consented to the study. 93 were randomized to the intervention group (alert) (n=46) or to usual care (no alert) group (n=47). This created 93 clusters (providers) to which eligible patient participants were assigned on their first eligible clinic visit. Eligible patient subjects were automatically identified, enrolled and randomized by our best practice alert based on their provider's randomization status (685 to the intervention group and 625 to usual care).", 'preAssignmentDetails': '7 provider subjects were excluded prior to randomization as patient recruitment finished before these providers saw an eligible patient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1310', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EHR-based Alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.\n\nBest practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '64', 'upperLimit': '81'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '80.8'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '63', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '478', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '908', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '614', 'groupId': 'BG000'}, {'value': '559', 'groupId': 'BG001'}, {'value': '1173', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', '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': '119', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '492', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '939', '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': '64', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medicaid/Medicare Enrollee', 'classes': [{'categories': [{'measurements': [{'value': '535', 'groupId': 'BG000'}, {'value': '582', 'groupId': 'BG001'}, {'value': '1117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'title': 'Atrial Arrhythmias', 'categories': [{'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG002'}]}]}, {'title': 'Coronary Artery Disease (CAD)', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Kidney Disease (CKD)', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}]}, {'title': 'Dyslipidemia', 'categories': [{'measurements': [{'value': '524', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1024', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '583', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1114', 'groupId': 'BG002'}]}]}, {'title': 'Obesity', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Pulmonary Disorders', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': 'Peripheral Vascular Disease', 'categories': [{'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '778', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Blood Pressure', 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000', 'lowerLimit': '108', 'upperLimit': '130'}, {'value': '118', 'groupId': 'BG001', 'lowerLimit': '108', 'upperLimit': '130'}, {'value': '120', 'groupId': 'BG002', 'lowerLimit': '108', 'upperLimit': '130'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '62', 'upperLimit': '78'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '78'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '62', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '84'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '83'}, {'value': '74', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Patients per provider type', 'classes': [{'title': 'Number of patients seen by physician', 'categories': [{'measurements': [{'value': '467', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '905', 'groupId': 'BG002'}]}]}, {'title': 'Number of patients seen by Advanced Practice Providers', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients on GDMT classes at baseline', 'classes': [{'title': 'Beta blockers', 'categories': [{'measurements': [{'value': '581', 'groupId': 'BG000'}, {'value': '517', 'groupId': 'BG001'}, {'value': '1098', 'groupId': 'BG002'}]}]}, {'title': 'ACE-I/ARB/ARNI', 'categories': [{'measurements': [{'value': '489', 'groupId': 'BG000'}, {'value': '437', 'groupId': 'BG001'}, {'value': '926', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin Converting Enzyme Inhibitor (ACE-I)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin Receptor Blocker (ARB)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin Receptor/Neprilysin Inhibitor (ARNI)', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}]}, {'title': 'Aldosterone Receptor Antagonist (MRA)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}]}, {'title': 'Sodium-Glucose cotransporter-2 inhibitor (SGLT2i)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '3.9', 'upperLimit': '4.6'}, {'value': '4.3', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '4.68'}, {'value': '4.3', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'BG000', 'lowerLimit': '0.95', 'upperLimit': '1.6'}, {'value': '1.2', 'groupId': 'BG001', 'lowerLimit': '0.94', 'upperLimit': '1.5'}, {'value': '1.2', 'groupId': 'BG002', 'lowerLimit': '0.95', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'groupId': 'BG000', 'lowerLimit': '40.1', 'upperLimit': '76.9'}, {'value': '58.4', 'groupId': 'BG001', 'lowerLimit': '41.2', 'upperLimit': '78.1'}, {'value': '57.8', 'groupId': 'BG002', 'lowerLimit': '40.7', 'upperLimit': '77.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Left Ventricular Ejection Fraction (LVEF)', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '36'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '37'}, {'value': '32', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent ejection fraction', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Baseline characteristics were not collected for provider subjects. Baseline characteristics are described for patient participants only as the exposure of interest would be expected to affect this study population and primary and secondary outcomes are collected only for patient subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-31', 'size': 1385216, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-09T14:16', 'hasProtocol': True}, {'date': '2021-05-13', 'size': 475700, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-09T14:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2020-07-29', 'resultsFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients on Beta Blockers', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with prescribed beta blockers'}, {'measure': 'Percentage of Patients on ACE Inhibitors', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ACEi'}, {'measure': 'Percentage of Patients on ARBs', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ARB'}, {'measure': 'Percentage of Patients on ARNIs', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed ARNI'}, {'measure': 'Percentage of Patients on MRAs', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed MRA'}, {'measure': 'Percentage of Patients on SGLT2 Inhibitors', 'timeFrame': 'Assessed from the date of randomization to 30 days post-randomization', 'description': 'Assessed as the number of patients with a prescribed SGLT2i'}, {'measure': 'Rate of One-year All-cause Mortality', 'timeFrame': 'Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization', 'description': 'Assessed as the number of patients who expired from randomization up to one year from any cause.'}, {'measure': 'Rate of 30-day Hospital Admission', 'timeFrame': 'Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization', 'description': 'Number of participants with a hospitalization within 30 days of randomization'}, {'measure': 'Rate of 30-day All-cause Emergency Department Visits', 'timeFrame': 'Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization', 'description': 'Number of participants with an emergency department visit within 30 days of randomization.'}, {'measure': 'Total Six-month Healthcare Costs', 'timeFrame': 'Assessed from the date of randomization to 6 months post-randomization', 'description': 'Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.'}, {'measure': 'Percentage of Filled Prescriptions', 'timeFrame': 'Assessed 6 months post-randomization', 'description': 'Proportion of prescriptions filled as assessed by SureScripts'}, {'measure': 'Medication Dose of Any Prescribed Beta Blocker', 'timeFrame': 'Assessed at 6 months post-randomization'}, {'measure': 'Medication Dose of Any Prescribed ACEi', 'timeFrame': 'Assessed at 6 months post-randomization'}, {'measure': 'Medication Dose of Any Prescribed ARB', 'timeFrame': 'Assessed at 6 months post-randomization'}, {'measure': 'Medication Dose of Any Prescribed ARNI', 'timeFrame': 'Assessed at 6 months post-randomization'}, {'measure': 'Medication Dose of Any Prescribed MRA', 'timeFrame': 'Assessed at 6 months post-randomization'}, {'measure': 'Medication Dose of Any Prescribed SGLT2 Inhibitor', 'timeFrame': 'Assessed at 6 months post-randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Reduced Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '35385798', 'type': 'DERIVED', 'citation': "Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3."}, {'pmid': '34808104', 'type': 'DERIVED', 'citation': "Ghazi L, Desai NR, Simonov M, Yamamoto Y, O'Connor KD, Riello RJ, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Ahmad T. Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Am Heart J. 2022 Feb;244:107-115. doi: 10.1016/j.ahj.2021.11.010. Epub 2021 Nov 20."}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.', 'detailedDescription': 'Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. However, data from several registries over the last three decades has failed to see use of these evidence based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field.\n\nIt remains unclear as to why many patients with HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.\n\nThis study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Age 18 or over\n* Seen in eligible internal medicine or cardiology clinic\n* Left ventricular ejection fraction less than or equal to 40%\n* Registered in the Yale Heart Failure Registry\n\nPatient Exclusion Criteria:\n\n* Opted out of EHR-based research\n* Under hospice care\n* Already receiving each targeted class of evidence-based HFrEF medical therapy\n\nSelection of Providers:\n\n* Practicing at an eligible internal medicine or cardiology clinic\n* High frequency of visits by eligible patients based on retrospective chart review'}, 'identificationModule': {'nctId': 'NCT04514458', 'acronym': 'PROMPT-HF', 'briefTitle': 'Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure', 'orgStudyIdInfo': {'id': '2000027014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EHR-based alert', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.", 'interventionNames': ['Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Providers will not receive an alert and will proceed with usual care.'}], 'interventions': [{'name': 'Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)', 'type': 'OTHER', 'description': "Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.", 'armGroupLabels': ['EHR-based alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Health System selected outpatient clinics', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Tariq Ahmad, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Upon publication of results; indefinitely.', 'ipdSharing': 'YES', 'description': 'Deidentified data underlying results for publication will be made available upon publication of results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}