Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-01-09 @ 8:07 PM
Study NCT ID:
NCT03221218
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2017-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Screening for Early Treatment Targets After MTBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Patients will be blinded to their group assignment. Family physicians will not be aware that they are involved in a research study until the completion of the study.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Family physician compliance with guidelines', 'timeFrame': '1 month after intervention.', 'description': 'Patient recall of receiving advice, referrals, and prescriptions from their family physician.'}], 'secondaryOutcomes': [{'measure': 'Family physician compliance with guidelines (chart review)', 'timeFrame': '6 to 12 months post injury', 'description': 'Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.'}, {'measure': 'Rivermead Post-Concussion Symptoms Questionnaire', 'timeFrame': '1- and 3-months after intervention.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '1- and 3-months after intervention.'}, {'measure': 'Personal Health Questionnaire-9 (PHQ-9)', 'timeFrame': '1- and 3-months after intervention.'}, {'measure': 'Insomnia Severity Scale (ISI)', 'timeFrame': '1- and 3-months after intervention.'}, {'measure': 'World Health Organization Disability Schedule (WHODAS-II) 12 item', 'timeFrame': '1- and 3-months after intervention.'}, {'measure': 'Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)', 'timeFrame': '1- and 3-months after intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Concussion']}, 'referencesModule': {'references': [{'pmid': '33382332', 'type': 'DERIVED', 'citation': 'Cassetta BD, Cairncross M, Brasher PMA, Panenka WJ, Silverberg ND. Avoidance and endurance coping after mild traumatic brain injury are associated with disability outcomes. Rehabil Psychol. 2021 May;66(2):160-169. doi: 10.1037/rep0000372. Epub 2020 Dec 31.'}, {'pmid': '33082178', 'type': 'DERIVED', 'citation': 'Silverberg ND, Panenka WJ, Lizotte PP, Bayley MT, Dance D, Li LC. Promoting early treatment for mild traumatic brain injury in primary care with a guideline implementation tool: a pilot cluster randomised trial. BMJ Open. 2020 Oct 20;10(10):e035527. doi: 10.1136/bmjopen-2019-035527.'}]}, 'descriptionModule': {'briefSummary': 'The study will examine whether enhancing screening-informed follow-up letters will improve (i) family physician compliance with best practice guidelines for managing persistent symptoms following concussion, and (ii) clinical outcomes from concussion.', 'detailedDescription': 'Family physicians are well positioned to proactively manage symptoms in the weeks following MTBI, which could prevent chronicity and reduce the need for specialist treatment. Clinical practice guidelines are now available for MTBI management in primary care, such as those developed by the Ontario Neurotrauma Foundation (ONF). However, awareness and use of these guidelines may be low. Distilling the guidelines into a small number of actionable messages that are tailored to an individual patient may facilitate family physician implementation.\n\nThe ONF guidelines for MTBI propose that early intervention should prioritize the most readily treatable symptoms - mood (depression and anxiety), insomnia, and headaches. The present cluster randomized trial will evaluate whether screening for these conditions and sending family physicians treatment algorithms for positive screening test results will result in earlier evidence-based treatment.\n\nPatients will be recruited from two concussion clinics that provide group education sessions. Following the education session, eligible participants will complete self-reported screening measures for depression, anxiety, insomnia, and headaches. Family physicians will be randomized to receive these screening test results with associated treatment algorithms from the ONF guidelines or a letter providing generic MTBI management recommendations from the ONF guidelines (currently done as usual care).\n\nPatients will be assessed by telephone one month and three months after the intervention. The primary outcome will be patient-reported treatment utilization that is congruent with the ONF guidelines for depression, anxiety, insomnia, and headaches after MTBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 60 years.\n* Has a family physician.\n* Physician diagnosed MTBI less than 3 months ago.\n* English reading comprehension sufficient for the consent form and standardized questionnaires.\n\nExclusion Criteria:\n\n* English reading comprehension not sufficient for the consent form and standardized questionnaires.'}, 'identificationModule': {'nctId': 'NCT03221218', 'briefTitle': 'Enhanced Screening for Early Treatment Targets After MTBI', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'H17-00584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced screening-informed letter', 'description': "Family physicians will receive a letter that includes their patient's screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines for MTBI (2013).", 'interventionNames': ['Other: Enhanced screening-informed follow up letter']}, {'type': 'NO_INTERVENTION', 'label': 'Standard letter', 'description': 'Family physicians will receive a letter that includes generic recommendations for managing MTBI based on the Ontario Neurotrauma Foundation clinical practice guidelines (2013). Screening test results will not be provided.'}], 'interventions': [{'name': 'Enhanced screening-informed follow up letter', 'type': 'OTHER', 'description': 'Family Physicians will be sent a letter that includes their screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines.', 'armGroupLabels': ['Enhanced screening-informed letter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GF Strong Rehab Centre, 4255 Laurel Street', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Noah Silverberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vancouver Coastal Health', 'class': 'OTHER_GOV'}, {'name': 'Fraser Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Noah Silverberg', 'investigatorAffiliation': 'University of British Columbia'}}}}