- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02328833
Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care (GPC-DEPc)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diego J Palao
- Phone Number: 0034937458376
- Email: dpalao@tauli.cat
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Implementation of Guidelines
Primary Care Centers where the experimental strategies of guidelines implementation will be done
|
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 Intervention: No Active Implementation of Guidelines
Primary Care Centers where the experimental strategies of guidelines implementation not will be done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time Frame: 4 months
|
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).
|
4 months
|
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time Frame: 6 months
|
6 months
|
|
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time Frame: 12 months
|
12 months
|
|
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of major depression patients registered in the electronical clinical record.
Time Frame: 6 months
|
New major depression cases (F32.**;
F33.**) registered in the electronical clinical record.
|
6 months
|
Incidence of major depression patients registered in the electronical clinical record.
Time Frame: 12 months
|
12 months
|
|
Incidence of major depression patients registered in the electronical clinical record.
Time Frame: 18 months
|
18 months
|
|
Rates of suicide and suicide attempts
Time Frame: 18 months
|
18 months
|
|
Total health cost of depression
Time Frame: 18 months
|
Direct and indirect health cost of major depression patients registered in electronical clinical record
|
18 months
|
Total referrals to mental health specialists
Time Frame: 6 months
|
6 months
|
|
Total referrals to mental health specialists
Time Frame: 12 months
|
12 months
|
|
Total referrals to mental health specialists
Time Frame: 18 months
|
18 months
|
|
Use Rate of the recommended antidepressives for the guideline
Time Frame: 6 months
|
6 months
|
|
Use Rate of the recommended antidepressives for the guideline
Time Frame: 12 months
|
12 months
|
|
Use Rate of the recommended antidepressives for the guideline
Time Frame: 18 months
|
18 months
|
|
Rate of patients in clinical remission
Time Frame: 6 months
|
The clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of < 5 points
|
6 months
|
Rate of patients in clinical remission
Time Frame: 12 months
|
12 months
|
|
Rate of patients in clinical remission
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Diego J Palao, Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM-CSPT-DP2014-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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