Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-22 @ 1:31 PM
Study NCT ID:
NCT01878968
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2013-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients opting out of routine care - no intubation', 'timeFrame': '48 hours', 'description': 'Number of patients in each group who opt out of intubation 48 hours after admission.'}, {'measure': 'Number of patients opting out of routine care - no CPR', 'timeFrame': '48 hours', 'description': 'Number of patients in each group who opt out of CPR within 48 hours of admission.'}], 'secondaryOutcomes': [{'measure': 'Hospital Mortality', 'timeFrame': "Length of patient's hospital stay", 'description': 'Number of deaths in each group in the hospital'}, {'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'Number of deaths in each group after 30 days.'}, {'measure': '90 day mortality', 'timeFrame': '90 days', 'description': 'Number of deaths in each group in 90 days.'}, {'measure': 'Number of patients undergoing CPR', 'timeFrame': "Length of patient's hospital stay", 'description': 'Number of patients in each group who undergo CPR during their hospitalization.'}, {'measure': 'Number of patients undergoing intubation', 'timeFrame': "Length of patient's hospital stay", 'description': 'Number of patients in each group who undergo intubation during their hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congestive Heart Failure', 'Infections', 'Sepsis', 'Acute Renal Failure', 'Stroke']}, 'descriptionModule': {'briefSummary': 'There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients\n* ≥65 yrs\n* Admitted to the hospitalist Medicine Service\n\nExclusion Criteria:\n\n* Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.\n* Patients already receiving critical care on admission will also be excluded'}, 'identificationModule': {'nctId': 'NCT01878968', 'briefTitle': "Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?", 'organization': {'class': 'OTHER', 'fullName': 'Jewish Hospital, Cincinnati, Ohio'}, 'officialTitle': "Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?", 'orgStudyIdInfo': {'id': '13-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Script and Video', 'description': 'Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video.', 'interventionNames': ['Other: Script and CPR/Mechanical ventilation video.']}, {'type': 'EXPERIMENTAL', 'label': 'Script only', 'description': 'Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.', 'interventionNames': ['Other: Script and CPR/Mechanical ventilation video.']}], 'interventions': [{'name': 'Script and CPR/Mechanical ventilation video.', 'type': 'OTHER', 'description': 'Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.', 'armGroupLabels': ['Script and Video', 'Script only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Jewish Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Imran Naqvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish Hospital of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish Hospital, Cincinnati, Ohio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Hospitalist, Associate Program Director Internal Medicine Residency', 'investigatorFullName': 'Imran Naqvi', 'investigatorAffiliation': 'Jewish Hospital, Cincinnati, Ohio'}}}}