Viewing Study NCT03441503


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Study NCT ID: NCT03441503
Status: TERMINATED
Last Update Posted: 2022-05-12
First Post: 2018-02-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Child HCAHPS: Automated Day of Discharge Survey
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', 'interventionModelDescription': 'This study is a rapid cycle randomized control trial. Participating units will alternate between the intervention arm (day of discharge survey via inpatient television) and control arm (post-discharge mailed survey). Patients will be assigned to the intervention or control arm depending on the status of their discharging unit. Units will alternate arms throughout the study period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23578}}, 'statusModule': {'whyStopped': 'We were not able to enroll partner hospitals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child HCAHPS Response Rate', 'timeFrame': 'up to 1 year', 'description': 'Change in response rate to the Child HCAHPS survey'}], 'secondaryOutcomes': [{'measure': 'Child HCAHPS Measure Top-Box Scores', 'timeFrame': 'up to 1 year', 'description': 'Change in Child HCAHPS top-box scores (i.e., percent of respondents selecting the most positive response option \\[0-100%\\]). Higher top-box scores imply better patient/family experience.'}, {'measure': 'Patient and respondent characteristics', 'timeFrame': 'up to 1 year', 'description': 'Difference in patient/respondent characteristics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inpatient Experience Survey Administration', 'Inpatient Experience Survey Response']}, 'referencesModule': {'references': [{'pmid': '26195542', 'type': 'BACKGROUND', 'citation': 'Toomey SL, Zaslavsky AM, Elliott MN, Gallagher PM, Fowler FJ Jr, Klein DJ, Shulman S, Ratner J, McGovern C, LeBlanc JL, Schuster MA. The Development of a Pediatric Inpatient Experience of Care Measure: Child HCAHPS. Pediatrics. 2015 Aug;136(2):360-9. doi: 10.1542/peds.2015-0966. Epub 2015 Jul 20.'}, {'pmid': '28330970', 'type': 'BACKGROUND', 'citation': 'Toomey SL, Elliott MN, Zaslavsky AM, Klein DJ, Ndon S, Hardy S, Wu M, Schuster MA. Variation in Family Experience of Pediatric Inpatient Care As Measured by Child HCAHPS. Pediatrics. 2017 Apr;139(4):e20163372. doi: 10.1542/peds.2016-3372. Epub 2017 Mar 22.'}, {'pmid': '20628281', 'type': 'BACKGROUND', 'citation': 'Gurland B, Alves-Ferreira PC, Sobol T, Kiran RP. Using technology to improve data capture and integration of patient-reported outcomes into clinical care: pilot results in a busy colorectal unit. Dis Colon Rectum. 2010 Aug;53(8):1168-75. doi: 10.1007/DCR.0b013e3181d87468.'}, {'pmid': '25899560', 'type': 'BACKGROUND', 'citation': 'Martin P, Brown MC, Espin-Garcia O, Cuffe S, Pringle D, Mahler M, Villeneuve J, Niu C, Charow R, Lam C, Shani RM, Hon H, Otsuka M, Xu W, Alibhai S, Jenkinson J, Liu G. Patient preference: a comparison of electronic patient-completed questionnaires with paper among cancer patients. Eur J Cancer Care (Engl). 2016 Mar;25(2):334-41. doi: 10.1111/ecc.12318. Epub 2015 Apr 20.'}, {'pmid': '24747981', 'type': 'BACKGROUND', 'citation': 'Turney BW, Reynard JM. Obtaining patient feedback in an outpatient lithotripsy service is facilitated by use of a touch-screen tablet (iPad) survey. Urolithiasis. 2014 Aug;42(4):317-21. doi: 10.1007/s00240-014-0662-3. Epub 2014 Apr 19.'}, {'pmid': '20413416', 'type': 'BACKGROUND', 'citation': 'Hofmann JN, Checkoway H, Borges O, Servin F, Fenske RA, Keifer MC. Development of a computer-based survey instrument for organophosphate and N-methyl-carbamate exposure assessment among agricultural pesticide handlers. Ann Occup Hyg. 2010 Aug;54(6):640-50. doi: 10.1093/annhyg/meq038. Epub 2010 Apr 22.'}, {'pmid': '15378105', 'type': 'BACKGROUND', 'citation': 'Mullen KH, Berry DL, Zierler BK. Computerized symptom and quality-of-life assessment for patients with cancer part II: acceptability and usability. Oncol Nurs Forum. 2004 Sep 17;31(5):E84-9. doi: 10.1188/04.ONF.E84-E89. Print 2004 Sep.'}, {'pmid': '19317857', 'type': 'BACKGROUND', 'citation': 'Elliott MN, Zaslavsky AM, Goldstein E, Lehrman W, Hambarsoomians K, Beckett MK, Giordano L. Effects of survey mode, patient mix, and nonresponse on CAHPS hospital survey scores. Health Serv Res. 2009 Apr;44(2 Pt 1):501-18. doi: 10.1111/j.1475-6773.2008.00914.x.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to identify effective ways to assess the patient and family experience. Specifically, the study will examine automated administration of the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey on the day of discharge through an electronic interactive patient care system. The will be a multisite study that will take place at Boston Children's Hospital (BCH) as well as at several other hospitals across the United States.", 'detailedDescription': 'Preliminary research conducted by BCH on alternative administration methods of Child HCAHPS has proven promising. Specifically, a pilot of administration on the day of discharge using tablet computers increased response rates, especially among hard to reach groups.\n\nTo further explore modes of Child HCAHPS day of discharge administration, the Center of Excellence for Pediatric Quality Measurement (CEPQM) at BCH is collaborating with GetWellNetwork (GetWell), a company that provides interactive education material for patient televisions, to enable parents and guardians to complete Child HCAHPS on the day of discharge from the inpatient television. For this multisite study, parents of hospitalized children from BCH and participating sites will be randomized at the time of discharge to either receiving Child HCAHPS on the day of discharge on the inpatient television or standard Child HCAHPS administration via mail or email. The study will continue for up to six months at each participating site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Their child's hospitalization includes at least one overnight stay\n\nExclusion Criteria:\n\n* Their child is aged 18 or older during the hospitalization\n* Their child is hospitalized with a primary psychiatric diagnosis\n* Their child dies during hospitalization\n* Their child is in the hospital as a court/law enforcement patient\n* Their child is a ward of the state\n* Their child was admitted under DCF jurisdiction\n* They are not fluent in English or Spanish"}, 'identificationModule': {'nctId': 'NCT03441503', 'briefTitle': 'Child HCAHPS: Automated Day of Discharge Survey', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Child HCAHPS: Day of Discharge Survey on an Electronic Interactive Patient Care System', 'orgStudyIdInfo': {'id': 'P00001745'}, 'secondaryIdInfos': [{'id': 'U18HS025299', 'link': 'https://reporter.nih.gov/quickSearch/U18HS025299', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child HCAHPS: Automated Administration', 'description': 'Child HCAHPS: Automated day-of-discharge survey\n\nOn the day of discharge at the hospital, parents will be contacted to solicit survey responses using patient televisions (GetWell) as follows:\n\nDay 0 (Day of likely discharge): Respondent will be promoted to complete Child HCAHPS on their television as part of the routine discharge process. Respondent will also be asked for their email address to complete post-discharge items and their appropriate contact information will be collected.\n\nDays 2-42: Standard hospital protocol (i.e., mail, email, or IVR) with the post-discharge questions.', 'interventionNames': ['Other: Child HCAHPS: Automated day-of-discharge survey']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Administration of Child HCAHPS', 'description': 'Parents will be contacted to complete Child HCAHPS using the standard protocol for mail, email, or IVR survey administration. The surveys will be administered by the survey vendor contracted by the participating site to administer Child HCAHPS.'}], 'interventions': [{'name': 'Child HCAHPS: Automated day-of-discharge survey', 'type': 'OTHER', 'description': 'Child HCAHPS surveys will be administered on the day of discharge via an electronic interactive patient care system on inpatient televisions.', 'armGroupLabels': ['Child HCAHPS: Automated Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': "Dayton Children's Hospital", 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}], 'overallOfficials': [{'name': 'Sara Toomey, MD, MPH, MPhil, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital, Harvard Medical School"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'GetWellNetwork', 'class': 'OTHER'}, {'name': "Dayton Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Principal Investigator and Director, Center of Excellence for Pediatric Quality Measurement; Chief Experience Officer, Boston Children's Hospital; Assistant Professor of Pediatrics, Harvard Medical School", 'investigatorFullName': 'Sara Toomey', 'investigatorAffiliation': "Boston Children's Hospital"}}}}