Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT02411669
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2015-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Tools for the Development of Patient Centered Care at Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self assessment score of patient centred care at hospital by health care professionals and patients', 'timeFrame': 'At study start in hospital, between 2 to 4 months before tool implementation'}, {'measure': 'Self assessment score of patient centred care at hospital by health care professionals and patients', 'timeFrame': '6 months after tool implementation for promoting patient centered care at hospital'}, {'measure': 'Self assessment score of patient centred care at hospital by health care professionals and patients', 'timeFrame': '18 months after tool implementation for promoting patient centered care at hospital'}], 'secondaryOutcomes': [{'measure': 'Patients global satisfaction score', 'timeFrame': 'At study start, between 2 to 4 months before tool implementation for promoting patient centered care at hospital, 6 month and 18 month after'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patient centred care'], 'conditions': ['Patient Centred Care']}, 'descriptionModule': {'briefSummary': "A national context for patient centered care development exists in France at hospital with strong support for the implementation of operational patient centered care tools. Patient centered care is a global vision of patient or family management promoting the respect of patient freedom, of patient listening and of patient needs. Patient centered care is an important issue of quality and security of care. The FORAP (Fédération des Organismes Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la HAS (High Authority of Health) have developed and validated five tools promoting patient centered care at hospital.\n\nThey can be implemented one by one or in association according to hospital situation. Hospitals should identify the association of tools fitting the most to their objectives and the actions already done.\n\nThe objectives of the project are to analyse the effectiveness of the implementation of HAS - FORAP tools on the development of patient centred care at hospital and to analyse the individual and organisational determinants of their effectiveness. It focuses on acute care hospitals that have the choice of the combination of tools and that are followed during two years with combined quantitative and qualitative analyses. Quantitative assessment are based on validated indicators on patient satisfaction, patient centred care development and organizational context. Qualitative data collection are realised in each included hospital and combine individual interviews and focus groups including Physicians, nurses and managerial staff."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There are 2 populations participating in this trials:\n\n* Health care professionals : physicians, nurses and managerial staff\n* Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'No specific eligibility criteria for health care professionals\n\nEligibility criteria for patients:\n\nInclusion Criteria:\n\n* Patients hospitalized for a minimum of 2 consecutive nights\n* Patients contact details known after hospitalization end\n\nExclusion Criteria:\n\n* Anonymous patient\n* Patient deceased during hospitalization\n* Patient non resident in France'}, 'identificationModule': {'nctId': 'NCT02411669', 'acronym': 'MoSTRA', 'briefTitle': 'Impact of Tools for the Development of Patient Centered Care at Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Effectiveness and Determinants of Effectiveness of Implementation of Tools for the Development of Patient Centred Care at Hospital', 'orgStudyIdInfo': {'id': 'CHUBX 2013/32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care professionals', 'description': 'Physicians, nurses and managerial staff', 'interventionNames': ['Other: Operational patient centered care tools']}], 'interventions': [{'name': 'Operational patient centered care tools', 'type': 'OTHER', 'description': "The FORAP (Fédération des Organismes Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la HAS (High Authority of Health) have developed and validated five tools promoting patient centered care at hospital.\n\nThey can be implemented one by one or in association according to hospital situation. Hospitals should identify the association of tools fitting the most to their objectives and the actions already done.", 'armGroupLabels': ['Health care professionals']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Agen', 'country': 'France', 'facility': "CH d'Agen", 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'city': 'Autun', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 46.95104, 'lon': 4.29869}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Maison de santé Marie Galène', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'Hôpital Privé Saint Martin', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'CH de Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Crest', 'country': 'France', 'facility': 'CH de Crest', 'geoPoint': {'lat': 44.72639, 'lon': 5.01517}}, {'city': 'Dax', 'country': 'France', 'facility': 'Clinique Saint Vincent', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'city': 'Dinan', 'country': 'France', 'facility': 'CH de Dinan', 'geoPoint': {'lat': 48.45553, 'lon': -2.05049}}, {'city': 'Dracy', 'country': 'France', 'facility': 'Centre orthopédique médico-chirurgical', 'geoPoint': {'lat': 47.75, 'lon': 3.25}}, {'city': 'Givors', 'country': 'France', 'facility': 'CH de Givors', 'geoPoint': {'lat': 45.59063, 'lon': 4.76878}}, {'city': 'Guingamp', 'country': 'France', 'facility': 'CH de Guingamp', 'geoPoint': {'lat': 48.56259, 'lon': -3.15289}}, {'city': 'Joigny', 'country': 'France', 'facility': 'CH de Joigny', 'geoPoint': {'lat': 47.98288, 'lon': 3.40096}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD de La Roche Sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Clinique Saint Charles', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Langon', 'country': 'France', 'facility': 'Clinique Saint Anne', 'geoPoint': {'lat': 44.55277, 'lon': -0.24986}}, {'city': "Les Sables-d'Olonne", 'country': 'France', 'facility': 'CH Côte de Lumière', 'geoPoint': {'lat': 46.49687, 'lon': -1.7847}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': "Clinique du Val d'Ouest", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Oyonnax', 'country': 'France', 'facility': 'CH du Haut-Bugey', 'geoPoint': {'lat': 46.25917, 'lon': 5.65727}}, {'city': 'Quimper', 'country': 'France', 'facility': 'CH intercommunal de Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'city': 'Redon', 'country': 'France', 'facility': 'CH de Redon', 'geoPoint': {'lat': 47.65165, 'lon': -2.08421}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'CH de St Brieuc', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Jean-de-Luz', 'country': 'France', 'facility': 'Polyclinique Côte Basque Sud', 'geoPoint': {'lat': 43.38871, 'lon': -1.66267}}, {'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CH de Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Vitré', 'country': 'France', 'facility': 'CH de Vitré', 'geoPoint': {'lat': 48.12279, 'lon': -1.20983}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}