NCT02328833

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

December 29, 2014

Last Update Submit

December 29, 2014

Conditions

Keywords

DepressionClinical Practice GuidelineImplementationPrimary CareComputerized Guideline

Outcome Measures

Primary Outcomes (4)

  • 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).

    4 months

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

    6 months

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

    12 months

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

    18 months

Secondary Outcomes (14)

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

    6 months

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

    12 months

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

    18 months

  • Rates of suicide and suicide attempts

    18 months

  • Total health cost of depression

    18 months

  • +9 more secondary outcomes

Study Arms (2)

Active Implementation of Guidelines

EXPERIMENTAL

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

Other: Experimental strategies of guidelines implementation

No Active Implementation of Guidelines

NO INTERVENTION

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

Interventions

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.

Active Implementation of Guidelines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 25500093BACKGROUND
  • 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.

    PMID: 20302995BACKGROUND
  • 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.

    PMID: 19452110BACKGROUND
  • 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.

    PMID: 22055213BACKGROUND
  • 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.

    PMID: 17498153BACKGROUND
  • Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.

    PMID: 17051309BACKGROUND

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Diego J Palao

    Corporacion Parc TaulĂ­ Sabadell, University Hospital (Barcelona, Spain)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego J Palao

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mental Health Director

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

December 31, 2014

Record last verified: 2014-12