Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT04359056
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2020-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Pharmacy for Patients with a PICC Line
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': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the number of complications during the interventional phase.', 'timeFrame': '3 months', 'description': 'Number of complications per patient and per month in each group. Number of complications per patient and per month in each group'}], 'secondaryOutcomes': [{'measure': 'Number of consultations and rehospitalizations post-discharge.', 'timeFrame': '3 months', 'description': 'Rates of consultations and rehospitalizations in each group.'}, {'measure': "Acceptance rate of pharmaceutical interventions (PI) during interventional phase and evaluation of PIs' criticality.", 'timeFrame': '3 months', 'description': 'Number of potentially inappropriate prescriptions resulting in an accepted PI over total of PIs.'}, {'measure': 'Conformity analysis of the PICC line logistic circuit', 'timeFrame': 'day 0', 'description': 'Number of correct items over total (items checklist about stock, supply chain, traceability)'}, {'measure': 'Conformity analysis of treatment indication.', 'timeFrame': 'day 0', 'description': 'Number of correct items over total (items checklist about recommended indications, implantation duration, etc.)'}, {'measure': 'Conformity analysis of hospital prescriptions issued in town.', 'timeFrame': 'day 0', 'description': 'Conformity rates per phase.'}, {'measure': "Patient's Quality Of Life assessment", 'timeFrame': 'at discharge', 'description': 'EQ-5D-5L score'}, {'measure': "Patient's Quality Of Life assessment", 'timeFrame': '3 months', 'description': 'EQ-5D-5L score'}, {'measure': 'Participants satisfaction survey', 'timeFrame': '3 months', 'description': "Assessment of patients' satisfactions regarding their therapeutic management"}, {'measure': 'healthcare professionals satisfaction survey', 'timeFrame': '3 months', 'description': "assessment of healthcare professionals' satisfactions regarding their collaboration with the pharmacists"}, {'measure': 'Direct hospital costs.', 'timeFrame': '3 months', 'description': 'description and evaluation of the direct medical costs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacists', 'Equipment and Supplies', 'Peripheral Catheterization', 'Operating Rooms', 'Hospital', 'Primary Health Care', 'Medical devices', 'PICC lines', 'clinical pharmacy', 'effectiveness', 'patient care management'], 'conditions': ['Catheter Complications']}, 'referencesModule': {'references': [{'pmid': '33827827', 'type': 'DERIVED', 'citation': 'Pouget AM, Civade E, Cestac P, Rouzaud-Laborde C. From hospitalisation to primary care: integrative model of clinical pharmacy with patients implanted with a PICC line-research protocol for a prospective before-after study. BMJ Open. 2021 Apr 7;11(4):e039490. doi: 10.1136/bmjopen-2020-039490.'}]}, 'descriptionModule': {'briefSummary': 'Clinical pharmacy is a patient-centered discipline and improves significantly the safety of drug management. Regarding medications, clinical pharmacy is efficient. The investigator hypothesize that clinical pharmacy applied to medical devices could be as effective as in the medication field.\n\nThe main objective of this study is to assess the effectiveness of clinical pharmacy activities during entire care pathways of patients implanted with a PICC line, in preventing complications.', 'detailedDescription': "This is a preliminary, before-after, monocentric and prospective study. The study will begin with an observational period and will be followed by an experimental intervention period. Sixty-nine adult patients in each period will be included. During the observational phase, no clinical pharmacy activities will be performed. During the interventional phase, clinical pharmacists will be active during the entire patients' care pathways."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, age equal to or older than 18 years old\n* Patient capable of giving free and informed consent\n* Patient insured by the Social Security System\n* Patient living at home\n* Patient with a PICC line prescription\n* Patient whose discharge prescription should contain drugs and MDs\n* Patient for home discharge implanted with a PICC line\n* Patient reachable by phone\n\nExclusion Criteria:\n\n* Under aged patient, age under 18 years old\n* Uninsured patient by the Social Security System\n* Patient not living at home :\n* Institutionalized patient\n* Patient living in a home for elderly dependent persons\n* Nursing home resident\n* Home-hospitalized patient\n* Patient deprived of liberty by a judicial or administrative decision\n* Patient under guardianship, curatorship or safeguard of justice\n* Patient unreachable by phone\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04359056', 'acronym': 'CLIPICC', 'briefTitle': 'Clinical Pharmacy for Patients with a PICC Line', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted with a PICC-line', 'orgStudyIdInfo': {'id': 'RC31/18/0459'}, 'secondaryIdInfos': [{'id': '2019-A02475-52', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'patients for the observational phase. This corresponds to usual cares where no clinical pharmacy activities will be performed'}, {'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'patients for the interventional phase where clinical pharmacy activities will be performed at each step of the care pathway: from hospitalization to home care.', 'interventionNames': ['Other: Clinical pharmacy activities along the care pathways']}], 'interventions': [{'name': 'Clinical pharmacy activities along the care pathways', 'type': 'OTHER', 'description': "PICC line implantation: Optimize the logistics circuit of the PICC line by rationalizing orders through the evaluation of potential losses.\n\nEnsure the due traceability of the implanted medical device. Discharge order : Analysis, optimization and pharmaceutical interventions if necessary Discharge Pharmaceutical Interview : Discussion with the patient, Information about the PICC line maintenance and associated therapies, Information about the prescribed drugs.\n\nCall to the community pharmacist to transfer the patient's prescription. Follow-up calls for 3 months after discharge\n\n* Patients: Two calls the first week after implantation, then one call per month for a maximum of 3 months, Clinical data collection :Pharmaceutical advices if necessary\n* Liberal nurses: same frequency, Clinical data collection, Pharmaceutical advices if necessary\n* Community pharmacist: one call per month, information relevant to the patient's follow-up will be collected.", 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'state': 'Occitanie', 'country': 'France', 'facility': 'CIVADE', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Charlotte ROUZAUD LABORDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': ': Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}