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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02328833
Acronym
GPC-DEPc
Enrollment
10
Registered
2014-12-31
Start date
2015-01-31
Completion date
2016-12-31
Last updated
2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Clinical Practice Guideline, Implementation, Primary Care, Computerized Guideline

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.

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.

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital Clinic of Barcelona
CollaboratorOTHER
Institut Catala de Salut
CollaboratorOTHER_GOV
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Rates of suicide and suicide attempts18 months
Total health cost of depression18 monthsDirect and indirect health cost of major depression patients registered in electronical clinical record
Incidence of major depression patients registered in the electronical clinical record.6 monthsNew major depression cases (F32.\*\*; F33.\*\*) registered in the electronical clinical record.
Use Rate of the recommended antidepressives for the guideline6 months
Rate of patients in clinical remission6 monthsThe clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of \< 5 points
Total referrals to mental health specialists6 months

Contacts

Primary ContactDiego J Palao
dpalao@tauli.cat0034937458376

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026