Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT05881434
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2022-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of a Questionnaire on Patients' Emergency Room Expectations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient reported provider understanding of patient's visit expectations", 'timeFrame': 'After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event', 'description': 'Q: "My ER provider understood my expectations for my ER visit today" with agreement responses on a 5-point Likert scale (strongly disagree to strongly agree)'}], 'secondaryOutcomes': [{'measure': 'Patient reported degree to which visit expectations were met', 'timeFrame': 'After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event', 'description': 'Q: "My expectations for my ER visit today were met" with agreement responses on a 5-point Likert scale (strongly disagree to strongly agree)'}, {'measure': 'Patient reported provider courtesy', 'timeFrame': 'After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event', 'description': 'Q: "Courtesy of your provider" with response options from Very Poor to Very Good'}, {'measure': 'Patient reported provider listening', 'timeFrame': 'After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event', 'description': 'Q: "Your provider took the time to listen to you" with response options from Very Poor to Very Good'}, {'measure': 'Patient reported inclusion in treatment decisions', 'timeFrame': 'After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event', 'description': 'Q: "Your provider included you in decisions about your treatment" with response options from Very Poor to Very Good'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergencies', 'Satisfaction, Patient', 'Expectations', 'Physician-Patient Relations']}, 'descriptionModule': {'briefSummary': "The goal of this study is to determine whether a novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) improves patient-provider communication as evaluated by an exit survey during an emergency room visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who arrive through the ED main entrance (non-EMS)\n* Patients aged 18 years and older\n* Patients who demonstrate decision making capacity\n* Patients who willingly consent to participate\n\nExclusion criteria:\n\n* Patients in distress (physical, emotional, or other) as determined by investigator\n* Patients who demonstrate altered mental status or lack of capacity to consent\n* Patients who require immediate medical intervention including diagnostic and/or treatment intervention\n* Prisoners and patient under involuntary holds'}, 'identificationModule': {'nctId': 'NCT05881434', 'briefTitle': "Influence of a Questionnaire on Patients' Emergency Room Expectations", 'organization': {'class': 'OTHER', 'fullName': 'Orange Park Medical Center'}, 'officialTitle': "Influence of a Questionnaire on Patients' Emergency Room Expectations", 'orgStudyIdInfo': {'id': 'Expectations'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expectations Questionnaire', 'description': 'Provision of expectations questionnaire and associated instructions to patient.', 'interventionNames': ['Other: Emergency Department Visit Expectations Questionnaire']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care (no expectations questionnaire or further instruction)'}], 'interventions': [{'name': 'Emergency Department Visit Expectations Questionnaire', 'type': 'OTHER', 'description': "Patients presented with novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) during check-in when arriving at the emergency department. Patients instructed to present the completed questionnaire to the treating provider.", 'armGroupLabels': ['Expectations Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Orange Park Medical Center', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orange Park Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}