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Status unknownNCT02328833GPC-DEPcUpdated Dec 31, 2014

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

An interventional study of Experimental strategies of guidelines implementation in Depression, sponsored by Corporacion Parc Tauli. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.

Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

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Keywords

  • Depression
  • Clinical Practice Guideline
  • Implementation
  • Primary Care
  • Computerized Guideline
03

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 10 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 166 studies on the registry; 24 are open to participants now.

Browse Corporacion Parc Tauli studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Active Implementation of Guidelines

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

    Other: Experimental strategies of guidelines implementation

  • No intervention
    No Active Implementation of Guidelines

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

Interventions

  • OtherExperimental 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 4 months

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 18 months

Secondary outcomes

  1. Incidence of major depression patients registered in the electronical clinical record.

    New major depression cases (F32.\*\*; F33.\*\*) registered in the electronical clinical record.

    Time frame: 6 months

  2. Incidence of major depression patients registered in the electronical clinical record.

    Time frame: 12 months

  3. Incidence of major depression patients registered in the electronical clinical record.

    Time frame: 18 months

  4. Rates of suicide and suicide attempts

    Time frame: 18 months

  5. Total health cost of depression

    Direct and indirect health cost of major depression patients registered in electronical clinical record

    Time frame: 18 months

  6. Total referrals to mental health specialists

    Time frame: 6 months

  7. Total referrals to mental health specialists

    Time frame: 12 months

  8. Total referrals to mental health specialists

    Time frame: 18 months

  9. Use Rate of the recommended antidepressives for the guideline

    Time frame: 6 months

  10. Use Rate of the recommended antidepressives for the guideline

    Time frame: 12 months

  11. Use Rate of the recommended antidepressives for the guideline

    Time frame: 18 months

  12. 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

    Time frame: 6 months

  13. Rate of patients in clinical remission

    Time frame: 12 months

  14. Rate of patients in clinical remission

    Time frame: 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25500093 ↗
  • 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. PubMed 20302995 ↗
  • 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. PubMed 19452110 ↗
  • 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. PubMed 22055213 ↗
  • 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. PubMed 17498153 ↗
  • Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58. PubMed 17051309 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02328833
Lead sponsor
Corporacion Parc Tauli
Collaborators
Instituto de Salud Carlos III, Hospital Clinic of Barcelona, Institut Catala de Salut
Responsible party
Diego J. Palao-VIdal (Mental Health Director, Corporacion Parc Tauli) — Principal investigator
First posted
Dec 31, 2014
Start date
Jan 2015
Primary completion
Jun 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Dec 31, 2014

Study contacts

Diego J Palao
Contact
dpalao@tauli.cat
0034937458376
Diego J Palao
principal investigator · Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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