Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care

NCT ID: NCT02328833

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

This 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.

A 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.

Conditions

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Depression

Keywords

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Depression Clinical Practice Guideline Implementation Primary Care Computerized Guideline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active Implementation of Guidelines

Primary Care Centers where the experimental strategies of guidelines implementation will be done

Group Type EXPERIMENTAL

Experimental strategies of guidelines implementation

Intervention Type OTHER

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.

No Active Implementation of Guidelines

Primary Care Centers where the experimental strategies of guidelines implementation not will be done

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental strategies of guidelines implementation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years.
* Diagnosis of major depression (F32. \*\*,F33.\*\* according to International Classification of Diseases-10)
* Attended in any of the 10 selected Primary Care Centers (from Barcelona, Spain)
* Patients with suspected depression in which the diagnosis is discarded using the Guide.

Exclusion Criteria

* Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Institut Catala de Salut

OTHER_GOV

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Diego J. Palao-VIdal

Mental Health Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego J Palao

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc TaulĂ­ Sabadell, University Hospital (Barcelona, Spain)

Central Contacts

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Diego J Palao

Role: CONTACT

Phone: 0034937458376

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 25500093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20302995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19452110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22055213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17498153 (View on PubMed)

Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.

Reference Type BACKGROUND
PMID: 17051309 (View on PubMed)

Related Links

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http://portal.guiasalud.es/GPC/GPC_534_Depresion_Adulto_Avaliat_resum.pdf

Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2014)

http://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2010/pdf/adaptacio_gpc_depressio_aiaqs_2010ca.pdf

Adaptation to the Catalan Health Model of the Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2010)

Other Identifiers

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SM-CSPT-DP2014-01

Identifier Type: -

Identifier Source: org_study_id