Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 5:59 PM
Study NCT ID:
NCT05715151
Status:
UNKNOWN
Last Update Posted:
2023-02-06
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Quality Improvement Cohorts on Advanced Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3rd next available appointment (weekly)', 'timeFrame': '18 month', 'description': 'Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.'}, {'measure': 'Percent of relational continuity (monthly)', 'timeFrame': '18 month', 'description': "Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients."}], 'secondaryOutcomes': [{'measure': 'Percent of 48-hour open slots (weekly)', 'timeFrame': '18 month', 'description': "Proportion of appointments available in the next 48 hours. Provides an overview of the provider's ability to respond to urgent care demands."}, {'measure': 'Use of walk-in (monthly)', 'timeFrame': '18 month', 'description': 'Proportion of walk-in visits by registered patients to each professional.'}, {'measure': 'Proportion of multidisciplinary involvement (monthly)', 'timeFrame': '18 month', 'description': 'Evaluates the proportion of involvement of different types of providers (social workers, nurses, pharmacists, etc.) with registered patients.'}, {'measure': 'Discontinuity for chronic patients (monthly)', 'timeFrame': '18 month', 'description': 'Proportion of chronic patients without any consultations within the last 12 months.'}, {'measure': '3rd next available appointment (weekly)', 'timeFrame': '12 month', 'description': 'Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.'}, {'measure': 'Percent of relational continuity (monthly)', 'timeFrame': '12 month', 'description': "Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Access', 'Primary Health Care', 'Quality improvement'], 'conditions': ['Primary Health Care']}, 'referencesModule': {'references': [{'pmid': '37038126', 'type': 'DERIVED', 'citation': 'Breton M, Gaboury I, Martin E, Green ME, Kiran T, Laberge M, Kaczorowski J, Ivers N, Deville-Stoetzel N, Bordeleau F, Beaulieu C, Descoteaux S. Impact of externally facilitated continuous quality improvement cohorts on Advanced Access to support primary healthcare teams: protocol for a quasi-randomized cluster trial. BMC Prim Care. 2023 Apr 11;24(1):97. doi: 10.1186/s12875-023-02048-y.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the implementation and effects of CQI cohorts on AA for PHC clinics. The main questions it aims to answer are to assess the effectiveness of CQI cohorts on AA outcomes.', 'detailedDescription': 'SIGNIFICANCE AND PURPOSE: Timely access to primary healthcare is one cornerstone of strong primary healthcare. Across Canada, timely access remains a significant challenge. One of the most highly recommended models around the world to improve timely access is advanced access (AA). Over the last two decades, AA has become increasingly popular in Canada. AA model has been widely promoted by the College of Family Physicians of Canada and several other provincial organizations and professional associations. Some tools to support the implementation of AA to PHC providers and practices have been developed such as workbook by Health Quality Ontario and Doctor of BC. However, those tools are important assets to initiate a reflection to improve, they are often not sufficient. Eight PHC teams interested in improving and expanding the implementation of AA have been coached through several PDSA cycles. However, the personalized support model used is very demanding in terms of capacity and resources. These findings guided the research team in developing and evaluating a Continuous Quality Improvement (CQI) Cohort program on advanced access to support Primary healthcare (PHC) teams.This study aims to develop knowledge on an externally facilitated CQI pan-Canadian cohort program that could potentially be transferred to provincial organizations or professional associations wishing to support clinics in quality improvement projects.\n\nOBJECTIVE: Assess the effectiveness of CQI cohorts on AA outcomes.\n\nQI INTERVENTION PROGRAM: PHC teams will participate in an externally facilitated CQI program focusing on AA. The proposed program consists of cycle of three key activities; 1) Interprofessional reflective sessions and need prioritization, 2) Group mentoring and PDSA Cycles and 3) Cohort cross-learning exchange opportunities.\n\nMETHODS: This study will be based on the cluster-controlled trial of a CQI program of PHC teams on AA. 48 PHC teams from Quebec will participate to the externally facilitated CQI cohort intervention. Volunteer clinics from the intervention regions will receive the CQI intervention for 18 months. Intervention clinics will be matched to PHC clinics located in other regions to compose the control group. The match will be based on the clinic level (1 to 10, based on the number of patients registered and services offered. Clinics in the control group will receive an audit on a selection of AA indicators and will be offered the intervention 12 to 18 months following their recruitment. Data collection and analysis will include quantitative data based on a comprehensive assessment of both AA processes and outcomes. These will be measured through a self-reflective survey for PHC team members, EMR data and patients related outcomes questionnaire on access. Qualitative data based on semi-structured interviews with key stakeholders, observations of the CQI activities and analysis of plans of action of documents plan of action will take place.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Clinics must offer interprofessional care.\n* At least 50 % of all team members should accept to take part in the study.\n\nExclusion criteria:\n\n* Solo Practice Physicians\n* Physician-nurse only model'}, 'identificationModule': {'nctId': 'NCT05715151', 'briefTitle': 'Continuous Quality Improvement Cohorts on Advanced Access', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Impact of Externally Facilitated Continuous Quality Improvement Cohorts on Advanced Access to Support Primary Healthcare Teams', 'orgStudyIdInfo': {'id': 'MP-04-2022-696'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CQI intervention', 'description': 'The proposed CQI cohort consists of three activities carried out iteratively until the improvement objectives are achieved.', 'interventionNames': ['Other: CQI intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Audit and feedback', 'description': 'Clinics in the control group will receive feedback on six key AA indicators, patients reported experience about access and selected AA processes.', 'interventionNames': ['Other: Audit and Feedback']}], 'interventions': [{'name': 'CQI intervention', 'type': 'OTHER', 'description': 'Activity 1: Reflective sessions and problem prioritisation. Activity 2: PDSA cycles. Activity 3: Group mentoring.', 'armGroupLabels': ['CQI intervention']}, {'name': 'Audit and Feedback', 'type': 'OTHER', 'description': 'Audit and Feedback on six key AA indicators, patients reported experience about access and selected AA processes.', 'armGroupLabels': ['Audit and feedback']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaspé', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS de la Gaspésie', 'geoPoint': {'lat': 48.83341, 'lon': -64.48194}}, {'zip': 'J8T 4J3', 'city': 'Gatineau', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': '07_CISSSO_CER@ssss.gouv.qc.ca', 'phone': '819 966-6000', 'phoneExt': '339199'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CISSS de l'Outaouais", 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'city': 'Joliette', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': 'recherche.cissslan@ssss.gouv.qc.ca'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS de Lanaudière', 'geoPoint': {'lat': 46.0164, 'lon': -73.4236}}, {'city': 'Laval', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Chantal Legris', 'role': 'CONTACT'}], 'facility': 'CISSS de Laval', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Lévis', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': 'gur.cisss-ca@ssss.gouv.qc.ca', 'phone': '418 835-7121', 'phoneExt': '11360'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS de Chaudière-Appalaches', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'city': 'Longueuil', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Helene Langelier', 'role': 'CONTACT', 'email': 'helene.langelier.cisssmc16@ssss.gouv.qc.ca', 'phone': '450 466.5000', 'phoneExt': '3894'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIUSSS de Montérégie-Centre', 'geoPoint': {'lat': 45.5152, 'lon': -73.46818}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sara Appadu', 'role': 'CONTACT', 'email': 'cer.cemtl@ssss.gouv.qc.ca', 'phone': '514 252-3400', 'phoneExt': '5708'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CIUSSS de l'Est-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CIUSSS de l'Ouest-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Serina Giagnotti', 'role': 'CONTACT', 'email': 'convenance@jgh.mcgill.ca', 'phone': '514-340-8222', 'phoneExt': '26785'}], 'facility': "CIUSSS du Centre-Ouest-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "CIUSSS du Centre-Sud-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "CIUSSS du Nord-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J9X 2A9', 'city': 'Rouyn-Noranda', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CISSS de l'Abitibi-Témiscamingue", 'geoPoint': {'lat': 48.23656, 'lon': -79.02311}}, {'zip': 'J3Y 6W9', 'city': 'Saint-Hubert', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Valerie Barbin', 'role': 'CONTACT', 'email': 'valerie.barbin.cisssmo16@ssss.gouv.qc.ca', 'phone': '(450) 445-2431', 'phoneExt': '2281'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS de la Montérégie-Ouest', 'geoPoint': {'lat': 45.50008, 'lon': -73.41583}}, {'zip': 'J2S 4Y8', 'city': 'Saint-Hyacinthe', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Julie Desormeau', 'role': 'CONTACT', 'email': 'julie.desormeau.cisssme16@ssss.gouv.qc.ca'}, {'name': 'Sonia Drolet', 'role': 'CONTACT', 'email': 'sonia.drolet.cisssme16@ssss.gouv.qc.ca'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS de la Montérégie-Est', 'geoPoint': {'lat': 45.63076, 'lon': -72.95699}}, {'city': 'Saint-Jérôme', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie-Ève Lapointe', 'role': 'CONTACT', 'email': 'cer.cissslau@ssss.gouv.qc.ca'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CISSS des Laurentides', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lisa Veilleux', 'role': 'CONTACT', 'email': 'lisa.veilleux.ciussse-chus@ssss.gouv.qc.ca'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CIUSSS de l'Estrie-CHUS", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Trois-Rivières', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': '04ethiqueciusssmcq@ssss.gouv.qc.ca', 'phone': '819 478-6464', 'phoneExt': '26478'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIUSSS de la Mauricie et Centre-du-Québec', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'G1M 3X7', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olivier Contensou', 'role': 'CONTACT', 'email': 'olivier.contensou.ciussscn@ssss.gouv.qc.ca'}, {'name': 'Mylaine Breton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIUSSS de la Capitale-Nationale', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Elisabeth Martin, Ph.D(c)', 'role': 'CONTACT', 'email': 'elisabeth.martin@usherbrooke.ca', 'phone': '5147799926'}], 'overallOfficials': [{'name': 'Mylaine Breton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isabelle Gaboury', 'class': 'UNKNOWN'}, {'name': 'Mike Green', 'class': 'UNKNOWN'}, {'name': 'Tara Kiran', 'class': 'UNKNOWN'}, {'name': 'Janusz Kaczorowski', 'class': 'UNKNOWN'}, {'name': 'Maude Laberge', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Community Health Sciences', 'investigatorFullName': 'Mylaine Breton', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}