Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
Study NCT ID:
NCT03892850
Status:
UNKNOWN
Last Update Posted:
2019-03-29
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000208', 'term': 'Acute Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055656', 'term': 'Prescriptions'}], 'ancestors': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 374}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no re-attendance during the following 72 hours', 'timeFrame': 'During next 72 hours', 'description': 'Options: Yes / No'}], 'secondaryOutcomes': [{'measure': 'Level of information and knowledge of the treatment', 'timeFrame': 'after 10 days'}, {'measure': 'adverse effects', 'timeFrame': 'after 10 days'}, {'measure': 'satisfaction level', 'timeFrame': 'after 10 days', 'description': 'Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied'}, {'measure': 'resolution of the health problem', 'timeFrame': 'after 10 days', 'description': 'Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved'}, {'measure': 'compliance', 'timeFrame': 'after 10 days', 'description': 'Options: Yes / No (Reason for answered no: Appearance of side effects, Disappearance of symptoms, Distrust of tto, Complicated dosage, No improvement of symptoms, I forget)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prescriptions', 'Nurses', 'Primary Health Care', 'Acute Disease'], 'conditions': ['Acute Disease']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the efficacy/effectiveness of pharmacological nurse prescription with medical prescription in patients attended in a primary care center for minor acute health problems.\n\nScope of the study: Multicenter study, with the participation of 8 primary care centers of Catalonia.\n\nMethodology: Randomized blind clinical trial, with experimental group receiving pharmacological nurse prescription and a control group receiving medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria, with random assignment of 374 subjects, 187 per group.\n\nThe efficacy/effectiveness of the prescribed treatment will be considered as a no re-attendance during the following 72h and will be completed with the variables: information and knowledge of the treatment, adverse effects, compliance, satisfaction level and resolution of the health problem. The data collection is done 10 days after the visit by an ad-hoc telephone questionnaire of 11 items, previously tested. The analysis is done using the SPSS software version 21.0, obtaining data of descriptive, multivariate and inferential statistics.\n\nImplications for practice: To evidence the equivalence of pharmacological nurse prescription with medical prescription for minor acute health problems'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Contusion\n* Diarrhea / vomit\n* Fever without focality\n* Flu\n* Urinary distress\n* Odinophagy\n* Toothache\n* Skin Bite\n* Upper respiratory symptoms\n* Ankle twist\n\nExclusion Criteria:\n\n* Language barrier\n* Cognitive deterioration\n* Sensory deficit\n* Pregnancy\n* Immunosuppression\n* Neoplasia in the last 5 years\n* Does not participate / Does not sign consent\n* Breastfeeding period\n* Reconsult\n* Resides outside of Spain\n* Treatment with glucocorticoids in the last 6 months'}, 'identificationModule': {'nctId': 'NCT03892850', 'briefTitle': 'Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity. Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '4R18/112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nurse prescription', 'description': 'experimental group receiving pharmacological nurse prescription', 'interventionNames': ['Behavioral: Nurse prescription']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'medical prescription', 'description': 'control group receiving medical prescription', 'interventionNames': ['Behavioral: Medical prescription']}], 'interventions': [{'name': 'Nurse prescription', 'type': 'BEHAVIORAL', 'description': 'Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria', 'armGroupLabels': ['nurse prescription']}, {'name': 'Medical prescription', 'type': 'BEHAVIORAL', 'description': 'Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria', 'armGroupLabels': ['medical prescription']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sonia Fernandez Molero, Nurse', 'role': 'CONTACT', 'email': 'sfernandez@casap.cat', 'phone': '+34637353101'}, {'name': 'Andres Baiget Ortega', 'role': 'CONTACT', 'email': 'abaigeto@gmail.com', 'phone': '+34652997848'}], 'overallOfficials': [{'name': 'Sonia Fernandez Molero, Sonia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}