search
Back to results

Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care (GPC-DEPc)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental strategies of guidelines implementation
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Depression, Clinical Practice Guideline, Implementation, Primary Care, Computerized Guideline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active Implementation of Guidelines

    No Active Implementation of Guidelines

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    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).
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.

    Secondary Outcome Measures

    Incidence of major depression patients registered in the electronical clinical record.
    New major depression cases (F32.**; F33.**) registered in the electronical clinical record.
    Incidence of major depression patients registered in the electronical clinical record.
    Incidence of major depression patients registered in the electronical clinical record.
    Rates of suicide and suicide attempts
    Total health cost of depression
    Direct and indirect health cost of major depression patients registered in electronical clinical record
    Total referrals to mental health specialists
    Total referrals to mental health specialists
    Total referrals to mental health specialists
    Use Rate of the recommended antidepressives for the guideline
    Use Rate of the recommended antidepressives for the guideline
    Use Rate of the recommended antidepressives for the guideline
    Rate of patients in clinical remission
    The clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of < 5 points
    Rate of patients in clinical remission
    Rate of patients in clinical remission

    Full Information

    First Posted
    December 29, 2014
    Last Updated
    December 29, 2014
    Sponsor
    Corporacion Parc Tauli
    Collaborators
    Instituto de Salud Carlos III, Hospital Clinic of Barcelona, Institut Catala de Salut
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02328833
    Brief Title
    Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
    Acronym
    GPC-DEPc
    Official Title
    Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Corporacion Parc Tauli
    Collaborators
    Instituto de Salud Carlos III, Hospital Clinic of Barcelona, Institut Catala de Salut

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Depression, Clinical Practice Guideline, Implementation, Primary Care, Computerized Guideline

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Implementation of Guidelines
    Arm Type
    Experimental
    Arm Description
    Primary Care Centers where the experimental strategies of guidelines implementation will be done
    Arm Title
    No Active Implementation of Guidelines
    Arm Type
    No Intervention
    Arm Description
    Primary Care Centers where the experimental strategies of guidelines implementation not will be done
    Intervention Type
    Other
    Intervention Name(s)
    Experimental strategies of guidelines implementation
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    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).
    Time Frame
    4 months
    Title
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    Time Frame
    6 months
    Title
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    Time Frame
    12 months
    Title
    The rate of patients in which the instruments from the Computerized Depression Guideline were used.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Incidence of major depression patients registered in the electronical clinical record.
    Description
    New major depression cases (F32.**; F33.**) registered in the electronical clinical record.
    Time Frame
    6 months
    Title
    Incidence of major depression patients registered in the electronical clinical record.
    Time Frame
    12 months
    Title
    Incidence of major depression patients registered in the electronical clinical record.
    Time Frame
    18 months
    Title
    Rates of suicide and suicide attempts
    Time Frame
    18 months
    Title
    Total health cost of depression
    Description
    Direct and indirect health cost of major depression patients registered in electronical clinical record
    Time Frame
    18 months
    Title
    Total referrals to mental health specialists
    Time Frame
    6 months
    Title
    Total referrals to mental health specialists
    Time Frame
    12 months
    Title
    Total referrals to mental health specialists
    Time Frame
    18 months
    Title
    Use Rate of the recommended antidepressives for the guideline
    Time Frame
    6 months
    Title
    Use Rate of the recommended antidepressives for the guideline
    Time Frame
    12 months
    Title
    Use Rate of the recommended antidepressives for the guideline
    Time Frame
    18 months
    Title
    Rate of patients in clinical remission
    Description
    The clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of < 5 points
    Time Frame
    6 months
    Title
    Rate of patients in clinical remission
    Time Frame
    12 months
    Title
    Rate of patients in clinical remission
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diego J Palao
    Phone
    0034937458376
    Email
    dpalao@tauli.cat
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diego J Palao
    Organizational Affiliation
    Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25500093
    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.
    Results Reference
    background
    PubMed Identifier
    20302995
    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.
    Results Reference
    background
    PubMed Identifier
    19452110
    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.
    Results Reference
    background
    PubMed Identifier
    22055213
    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.
    Results Reference
    background
    PubMed Identifier
    17498153
    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.
    Results Reference
    background
    PubMed Identifier
    17051309
    Citation
    Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.
    Results Reference
    background
    Links:
    URL
    http://portal.guiasalud.es/GPC/GPC_534_Depresion_Adulto_Avaliat_resum.pdf
    Description
    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
    Description
    Adaptation to the Catalan Health Model of the Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2010)

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs