Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-29 @ 10:27 AM
Study NCT ID:
NCT05232656
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential Post-Discharge Adverse Events', 'timeFrame': '24 months', 'description': 'Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient'}], 'secondaryOutcomes': [{'measure': 'Actual Post-Discharge Adverse Events', 'timeFrame': '24 months', 'description': 'Actual post-discharge adverse events will be measured as the number of adverse events per patient'}, {'measure': 'Preventable Post-Discharge Adverse Events', 'timeFrame': '24 months', 'description': 'Actual post-discharge adverse events related to preventable harm will be measured as the number of post-discharge adverse events per patient related to a specific safety risk domain identified during index hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transitions of Care', 'General Medicine', 'Discharge Checklist', 'Adverse Event']}, 'referencesModule': {'references': [{'pmid': '39013194', 'type': 'DERIVED', 'citation': "Vasudevan A, Plombon S, Piniella N, Garber A, Malik M, O'Fallon E, Goyal A, Gershanik E, Kumar V, Fiskio J, Yoon C, Lipsitz SR, Schnipper JL, Dalal AK. Effect of digital tools to promote hospital quality and safety on adverse events after discharge. J Am Med Inform Assoc. 2024 Oct 1;31(10):2304-2314. doi: 10.1093/jamia/ocae176."}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:\n\n1. Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.\n2. Expand intervention to general medical units at our community hospital-affiliate, BWFH.\n3. Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.', 'detailedDescription': 'Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.\n\nStudying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, \\>18 years of age, English-speaking\n* Caregivers \\>18 years of age designated by patient or patient's healthcare proxy\n* Two or more patient safety risk factors\n\nExclusion Criteria:\n\n\\- Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy"}, 'identificationModule': {'nctId': 'NCT05232656', 'acronym': 'PREDICT', 'briefTitle': 'PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Impact of an Epic-integrated Safety Dashboard and Interactive Pre-discharge Checklist on Post-discharge Adverse Events', 'orgStudyIdInfo': {'id': '2018P001137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-intervention', 'description': 'Usual care on three general medicine units.\n\nPatients/caregivers do no have access to the discharge preparation checklist. Providers do not have access to the safety dashboard.'}, {'type': 'EXPERIMENTAL', 'label': 'Post-intervention', 'description': 'Patients/caregivers have access to the pre-discharge preparation checklist. Providers have access to patient safety dashboard.', 'interventionNames': ['Behavioral: Pre-Discharge Checklist and Patient Safety Dashboard']}], 'interventions': [{'name': 'Pre-Discharge Checklist and Patient Safety Dashboard', 'type': 'BEHAVIORAL', 'description': 'Pre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients.', 'armGroupLabels': ['Post-intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anuj K Dalal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Crico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Physician', 'investigatorFullName': 'Anuj K. Dalal, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}