Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-01-12 @ 2:36 AM
Study NCT ID:
NCT02328833
Status:
UNKNOWN
Last Update Posted:
2014-12-31
First Post:
2014-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of patients in which the instruments from the Computerized Depression Guideline were used.', 'timeFrame': '4 months', 'description': 'The rate of patients with possible depression treated in the analyzed period in which at least one of the instruments that the Guide recommended were used (to rule out or confirm the diagnosis, choose the optimal treatment or the best clinical follow-up option).'}, {'measure': 'The rate of patients in which the instruments from the Computerized Depression Guideline were used.', 'timeFrame': '6 months'}, {'measure': 'The rate of patients in which the instruments from the Computerized Depression Guideline were used.', 'timeFrame': '12 months'}, {'measure': 'The rate of patients in which the instruments from the Computerized Depression Guideline were used.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of major depression patients registered in the electronical clinical record.', 'timeFrame': '6 months', 'description': 'New major depression cases (F32.\\*\\*; F33.\\*\\*) registered in the electronical clinical record.'}, {'measure': 'Incidence of major depression patients registered in the electronical clinical record.', 'timeFrame': '12 months'}, {'measure': 'Incidence of major depression patients registered in the electronical clinical record.', 'timeFrame': '18 months'}, {'measure': 'Rates of suicide and suicide attempts', 'timeFrame': '18 months'}, {'measure': 'Total health cost of depression', 'timeFrame': '18 months', 'description': 'Direct and indirect health cost of major depression patients registered in electronical clinical record'}, {'measure': 'Total referrals to mental health specialists', 'timeFrame': '6 months'}, {'measure': 'Total referrals to mental health specialists', 'timeFrame': '12 months'}, {'measure': 'Total referrals to mental health specialists', 'timeFrame': '18 months'}, {'measure': 'Use Rate of the recommended antidepressives for the guideline', 'timeFrame': '6 months'}, {'measure': 'Use Rate of the recommended antidepressives for the guideline', 'timeFrame': '12 months'}, {'measure': 'Use Rate of the recommended antidepressives for the guideline', 'timeFrame': '18 months'}, {'measure': 'Rate of patients in clinical remission', 'timeFrame': '6 months', 'description': 'The clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of \\< 5 points'}, {'measure': 'Rate of patients in clinical remission', 'timeFrame': '12 months'}, {'measure': 'Rate of patients in clinical remission', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Clinical Practice Guideline', 'Implementation', 'Primary Care', 'Computerized Guideline'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '25500093', 'type': 'BACKGROUND', 'citation': 'Trinanes Y, Atienza G, Louro-Gonzalez A, de-las-Heras-Linero E, Alvarez-Ariza M, Palao DJ. Development and impact of computerised decision support systems for clinical management of depression: A systematic review. Rev Psiquiatr Salud Ment. 2015 Jul-Sep;8(3):157-66. doi: 10.1016/j.rpsm.2014.10.004. Epub 2014 Dec 12. English, Spanish.'}, {'pmid': '20302995', 'type': 'BACKGROUND', 'citation': 'Fernandez A, Pinto-Meza A, Bellon JA, Roura-Poch P, Haro JM, Autonell J, Palao DJ, Penarrubia MT, Fernandez R, Blanco E, Luciano JV, Serrano-Blanco A. Is major depression adequately diagnosed and treated by general practitioners? Results from an epidemiological study. Gen Hosp Psychiatry. 2010 Mar-Apr;32(2):201-9. doi: 10.1016/j.genhosppsych.2009.11.015. Epub 2010 Jan 12.'}, {'pmid': '19452110', 'type': 'BACKGROUND', 'citation': 'Serrano-Blanco A, Palao DJ, Luciano JV, Pinto-Meza A, Lujan L, Fernandez A, Roura P, Bertsch J, Mercader M, Haro JM. Prevalence of mental disorders in primary care: results from the diagnosis and treatment of mental disorders in primary care study (DASMAP). Soc Psychiatry Psychiatr Epidemiol. 2010 Feb;45(2):201-10. doi: 10.1007/s00127-009-0056-y. Epub 2009 May 19.'}, {'pmid': '22055213', 'type': 'BACKGROUND', 'citation': 'Pamias Massana M, Crespo Palomo C, Gisbert Gelonch R, Palao Vidal DJ. [The social cost of depression in the city of Sabadell (Barcelona, Spain) (2007-2008)]. Gac Sanit. 2012 Mar-Apr;26(2):153-8. doi: 10.1016/j.gaceta.2011.07.019. Epub 2011 Nov 3. Spanish.'}, {'pmid': '17498153', 'type': 'BACKGROUND', 'citation': 'Weinmann S, Koesters M, Becker T. Effects of implementation of psychiatric guidelines on provider performance and patient outcome: systematic review. Acta Psychiatr Scand. 2007 Jun;115(6):420-33. doi: 10.1111/j.1600-0447.2007.01016.x.'}, {'pmid': '17051309', 'type': 'BACKGROUND', 'citation': 'Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.'}], 'seeAlsoLinks': [{'url': 'http://portal.guiasalud.es/GPC/GPC_534_Depresion_Adulto_Avaliat_resum.pdf', 'label': 'Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2014)'}, {'url': 'http://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2010/pdf/adaptacio_gpc_depressio_aiaqs_2010ca.pdf', 'label': 'Adaptation to the Catalan Health Model of the Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2010)'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of an active multifactor implementation process of a Computerized Depression Guideline in Primary Care. The CPG-DEPc use use, the key outcomes and its maintenance over time in patients and professionals will be analyzed.', 'detailedDescription': 'The application of scientific evidence on major depression in clinical practice is complex. Many studies show that over 50% of depressed patients in primary care do not receive proper attention, or are ineffective or potentially harmful treatments. In general, the process of dissemination and implementation of Clinical Practice Guidelines (CPG) in printed version induce a minor improvement in clinical practice. The adaptation of the CPG of Major Depression in Adults (CPG-DEPC) in Catalonia (Spain), as a computerized integrated version, offers an extraordinary opportunity to improve outcomes in Primary Care. The integrated design allows precise access to help in the visit itself, to improve diagnosis validation process, the recommended treatment and facilitate monitoring and evaluation of suicide risk in depressed patients.\n\nThis study aims to evaluate the effects of an active multifactor implementation process of a Computerized Depression Guideline in Primary Care. The GPC-DEPc use, the key outcomes and its maintenance over time in patients and professionals will be analyzed.\n\nA cluster randomized trial, multicenter study in ten Primary Care Centers in Barcelona, coordinated by the same Mental Health Service, will be done. In five of the Centers will be actively implemented the CPG-DEPc and the other five will proceed as usual process, as a reference. The active process includes the establishment of local implementation teams, seminars, regular feedback and follow-up visits for four months. The main outcome will be the rate of patients with possible depression treated in the analyzed period in which at least were used any of the instruments that the Guide recommended (to rule out or confirm the diagnosis, choose the optimal treatment or follow-up the clinical maintenance best options). Other professionals and patients secondary outcome measures will be analyzed (incidence of major depression registers, referrals to mental health specialists, use of recommended antidepressants and rates of patients in clinical remission). At the end of the study, the suicide and suicide attempts rate and the data about the direct and indirect health cost will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years.\n* Diagnosis of major depression (F32. \\*\\*,F33.\\*\\* according to International Classification of Diseases-10)\n* Attended in any of the 10 selected Primary Care Centers (from Barcelona, Spain)\n* Patients with suspected depression in which the diagnosis is discarded using the Guide.\n\nExclusion Criteria:\n\n* Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02328833', 'acronym': 'GPC-DEPc', 'briefTitle': 'Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care', 'orgStudyIdInfo': {'id': 'SM-CSPT-DP2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Implementation of Guidelines', 'description': 'Primary Care Centers where the experimental strategies of guidelines implementation will be done', 'interventionNames': ['Other: Experimental strategies of guidelines implementation']}, {'type': 'NO_INTERVENTION', 'label': 'No Active Implementation of Guidelines', 'description': 'Primary Care Centers where the experimental strategies of guidelines implementation not will be done'}], 'interventions': [{'name': 'Experimental strategies of guidelines implementation', 'type': 'OTHER', 'description': 'Experimental strategies of Depression Guidelines implementation in Primary Care Centers. The active process includes the establishment of local implementation teams, seminars, regular feedback and follow-up visits for four months.', 'armGroupLabels': ['Active Implementation of Guidelines']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Diego J Palao', 'role': 'CONTACT', 'email': 'dpalao@tauli.cat', 'phone': '0034937458376'}], 'overallOfficials': [{'name': 'Diego J Palao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Institut Catala de Salut', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mental Health Director', 'investigatorFullName': 'Diego J. Palao-VIdal', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}