Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT04458428
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2020-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Message Service Based Patient Education in Spine Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpineFriend Postoperative Questionnaire', 'timeFrame': 'Follow Up Visits at 2 or 6 weeks', 'description': 'Patient satisfaction will consist of the SpineFriend Postoperative Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spine Surgery', 'Short Message Service (SMS)', 'Patient Satisfaction'], 'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'The investigators primary objective is to evaluate whether an SMS based patient education program improves patient satisfaction.', 'detailedDescription': 'Back and neck related complaints effect as much as 11% of the U.S. population and are one of the most common presenting complaints at health care visits. A small subset of these patients receive spine surgery of various types in the hopes of alleviating symptoms that are recalcitrant to conservative management. The utilization of spine surgery has been rapidly increasing.2 An estimated 413,000 spinal fusions were performed in the U.S. in 2008 accounting for almost $34 billion in charges.\n\nPatient satisfaction has become an increasingly important measure of healthcare quality. This paradigm shift is evident in the changing reimbursement models used by the Centers for Medicare and Medicaid Services (CMS). Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a survey-based assessment of patient satisfaction that was initially developed in 2002. Currently, HCAHPS provides the ability to compare patient satisfaction with the care they receive at various healthcare systems across the country. These scores are used as part of a value-based purchasing initiative that can lead to a hospital gaining or losing as much as 1.5% of their annual medicare revenue as a result of patient satisfaction based incentives. This presents an important opportunity to optimize patient satisfaction in order to both improve patient care and preserve hospital income.\n\nA number of novel text-message based applications have been developed for healthcare use in various settings. In the surgical setting text messaging has been used to provide pre-operative education modules, as well as to track medication adherence after transplant. This study aims to develop and critically evaluate, a text-messaging based patient education system aimed at improving patient satisfaction with the post-operative course after spine surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years and over undergoing spine surgery at the University of Utah\n\nExclusion Criteria:\n\n* Patients under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT04458428', 'acronym': 'SMS', 'briefTitle': 'Short Message Service Based Patient Education in Spine Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The Role of Postoperative SMS Based Patient Education in Spine Patients', 'orgStudyIdInfo': {'id': '98177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No other non-standard of care activities will be performed'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Will be signed up for the automated short message service (SMS)', 'interventionNames': ['Other: SMS']}], 'interventions': [{'name': 'SMS', 'type': 'OTHER', 'description': 'Patients who are randomized to the intervention arm will be signed up for the automated SMS program. This cohort will receive text messages after surgery, timed from the day of discharge through 14 days post-op. Patients in this cohort will receive text messages each day. The number of text messages varies on patient interest and "yes" responses to see additional information.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopedics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Ryan Spiker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ryan Spiker', 'investigatorAffiliation': 'University of Utah'}}}}