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
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
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
NCT ID
NCT02328833
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
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)
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Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
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