Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 7:43 AM
Study NCT ID:
NCT05552534
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and efficacy of a smoking cessation intervention', 'timeFrame': '3 months after emergency consultation', 'description': 'Composite outcome: Proportion of patients who participated in follow-up consultations at 3 months after going to the emergency room and proportion of patients weaned from smoking at three months in the intervention group, compared to the control group.\n\nA patient is said to be weaned if he / she declares having stopped smoking for 7 days 3 months after his / her visit to the emergency room'}], 'secondaryOutcomes': [{'measure': 'proportion of patients who participated in consultations at D7 and M1', 'timeFrame': 'Day 7 and 1 month after emergency consultation', 'description': 'Assessment of the patient circuit'}, {'measure': 'description of the procedure (duration of the inclusion)', 'timeFrame': '4 months', 'description': 'Description of the research circuit'}, {'measure': 'number of patients who refused to participate', 'timeFrame': '4 months', 'description': "Description of the procedure's barriers"}, {'measure': 'Number of doctors/paramedics involved, and of staff who performed the follow-up', 'timeFrame': '4 months', 'description': 'Description of staff involved'}, {'measure': 'Feasibility of measuring exhaled carbon monoxide', 'timeFrame': '3 months after emergency consultation', 'description': 'Proportion of patients with a carbon monoxide measurement expired'}, {'measure': 'Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal', 'timeFrame': '3 months after emergency consultation'}, {'measure': 'Effectiveness of the smoking cessation intervention', 'timeFrame': 'Day 7 and 1 month after emergency consultation', 'description': 'Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone'}, {'measure': 'Number of smoked cigarettes', 'timeFrame': 'Day 7, 1 month and 3 month after emergency consultation', 'description': 'Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative'}, {'measure': "Patients' adherence to the intervention", 'timeFrame': '3 month after emergency consultation', 'description': '\\- Questionnaire with Likert scale: In order to measure adherence to the intervention, 13 sentences in favor of the intervention : answers from 1. I strongly disagree to 5 . I completely agree.\n\nA higher score mean a better adherence (min: 13, max : 65).\n\n\\- Proportion of patients who completed follow-up consultations at 7 days and one month'}, {'measure': "Emergency teams' adherence to the intervention", 'timeFrame': '3 month after emergency consultation', 'description': 'Questionnaire with Likert scale: In order to measure adherence to the intervention, 11 sentences in favor of the intervention : answers from 1. I strongly disagree to 5 . I completely agree.\n\nA higher score mean a better adherence (min: 11, max : 55).'}, {'measure': "Patients ' adherence to the intervention, according to demographic criteria.", 'timeFrame': '3 month after emergency', 'description': 'Description of the population according to age, gender, socio-economic characteristics, grounds for appeal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency medicine', 'Public Health', 'Addictionology', 'Smoking cessation', 'Tobacco dependence treatment'], 'conditions': ['Tobacco Cessation']}, 'descriptionModule': {'briefSummary': 'Smoking cessation assistance is one of the major issues in prevention policies because the prevalence of smoking remains high in France. With its numerous consultations, an emergency service seems to be an interesting place for setting up and helping with weaning, despite specific working conditions. The study, which is a pilot, is interested in the feasibility and efficacy of the implementation of a STIR (Screening, Treatment Intervention and Referral) protocol, which screening, brief intervention, nicotine replacement therapy and referral to a specialist in order to help the patients in smoking cessation.', 'detailedDescription': 'Individual randomization as soon as the patient gives his consent and meets the inclusion - non-inclusion criteria.\n\nControl group: delivery of the "tobacco-info-service" brochure titled "Why quit smoking? ", then phone call at 7 days and a month to collect tobacco consumption. Visit for 3 month. Intervention group: STIR protocol (screening, brief intervention, incentive to download the tobacco info service application, delivery of the "tobacco-info-service" brochure, initiation of a nicotine replacement therapy with nicotine patches made by a trained emergency nurse or doctor, then three consultations face-to-face or remotely with a member of the team addictionology at 7 days, 1 and 3 months.\n\nIn both groups: collection of the primary endpoint during the M3 visit. For patients who did not come (regardless of the group):\n\ncall for collection of the main judgment criterion\n\nCarers will be included and will sign a consent form once the eligibility criteria have been checked and consent has been signed. They will be asked to complete an adherence questionnaire (Likert scale) regarding smoking prevention in emergency departments before the start of the study and after the last patient follow-up has taken place.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= to 18 years old\n* Active smoker defined by having smoked at least 100 cigarettes in total in his life, associated with daily consumption or weekly\n* Free and informed consent signed by the patient\n* Patient with an understanding of the French language to participate in the intervention if necessary\n* Patient affiliated to a social security regimen\n\nCare giver inclusion criteria:\n\n* Age ≥ 18 years\n* Caregiver working in one of the 3 departments participating in the study\n* Signature of free and informed consent\n\nExclusion Criteria:\n\n* Absolute vital emergency\n* Pregnant or breastfeeding women\n* Contraindication to taking nicotine\n* Taking nicotine by patch or gum or e-cigarette\n* Patient under AME (national medical insurance)\n* Patients under guardianship'}, 'identificationModule': {'nctId': 'NCT05552534', 'acronym': 'PROSCEED', 'briefTitle': 'Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of an Intervention of Screening, Treatment Initiation and Referral to Promote Smoking Cessation in Emergency Department Patients: the Pilot PROSCEED Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'APHP220066'}, 'secondaryIdInfos': [{'id': 'ID RCB 2021-A03003-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Other: STIR PROTOCOL']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'STIR PROTOCOL', 'type': 'OTHER', 'description': 'Screening, STIR protocol (screening, brief intervention, incentive to download the tobacco info service application, delivery of the "tobacco-info-service" brochure, initiation of a nicotine patch made by the trained emergency nurse or doctor) then three consultations face-to-face or remotely with a member of the team addictionology at 7 days, 1 and 3 months.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Emergency department Hospital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Anne Laure Philippon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}