Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT02076360
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT: Impact of Preop Video on Patient Preparedness for Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "patients' preparedness for surgery", 'timeFrame': 'prior to surgery (baseline)', 'description': "patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery"}, {'measure': 'Patient preparedness for surgery', 'timeFrame': '2 week postop visit', 'description': "patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery"}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '2 weeks postop', 'description': 'patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire'}, {'measure': 'perception of time', 'timeFrame': 'prior to surgery (baseline)', 'description': "patients' perception of time spent with healthcare team"}, {'measure': 'Actual facetime spent', 'timeFrame': 'prior to surgery (baseline)', 'description': 'Actual facetime spent between physician and patient during preoperative counseling session measured in minutes'}, {'measure': 'QOL', 'timeFrame': '2 weeks postop', 'description': 'Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement \\[PGI-I\\])'}, {'measure': 'POPQ', 'timeFrame': '2 weeks postop', 'description': 'Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'prior to surgery (baseline)', 'description': 'patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preoperative counseling', 'Patient satisfaction', 'Prolapse', 'Sacrocolpopexy'], 'conditions': ['Prolapse']}, 'referencesModule': {'references': [{'pmid': '28431952', 'type': 'DERIVED', 'citation': 'Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18.'}]}, 'descriptionModule': {'briefSummary': "This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes.\n\nThe aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit.\n\nObjective:\n\nA. Primary Aim(s):\n\n• To determine if patients feel more prepared for surgery with addition of preoperative patient education video\n\nB. Secondary Aim(s):\n\n* To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery\n* To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video\n* To determine if actual patient-physician time spent counseling differs between groups\n* To determine if patient preparedness is correlated with objective surgical outcomes\n* To determine if patient preparedness is correlated with patient symptom improvement scores after surgery\n\nHypothesis:\n\nThe addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women \\>18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy\n* It is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned\n* English speaking\n* Willing and able to provide written and informed consent\n\nExclusion Criteria:\n\n* Women \\<18\n* Not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy\n* Non-English speaking\n* Unable or unwilling to provide written and informed consent'}, 'identificationModule': {'nctId': 'NCT02076360', 'briefTitle': 'RCT: Impact of Preop Video on Patient Preparedness for Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro00013617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preop Video', 'description': 'This arm will watch an instructional video in addition to their normal preoperative visit with the physician.', 'interventionNames': ['Behavioral: Preoperative Video']}, {'type': 'NO_INTERVENTION', 'label': 'No video', 'description': 'This arm will receive only the normal preoperative visit with the physician without the additional video'}], 'interventions': [{'name': 'Preoperative Video', 'type': 'BEHAVIORAL', 'description': 'Patients will watch preoperative instructional video', 'armGroupLabels': ['Preop Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Urogynecology clinic', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Kristie Greene, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}