DepressionGPC-DEPcNCT02328833
Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
A study testing Experimental strategies of guidelines implementation in people with Depression, run by Corporacion Parc Tauli.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Experimental strategies of guidelines implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Depression
- Being tested
- Experimental strategies of guidelines implementation
- Keywords
- Depression, Clinical Practice Guideline, Implementation, Primary Care, Computerized Guideline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental strategies of guidelines implementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Implementation of Guidelines | Experimental | Primary Care Centers where the experimental strategies of guidelines implementation will be done Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Measured: 6 months
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Measured: 12 months
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Measured: 18 months
Secondary outcomes (14)
Incidence of major depression patients registered in the electronical clinical record.
New major depression cases (F32.; F33.) registered in the electronical clinical record.
Measured: 6 months
Incidence of major depression patients registered in the electronical clinical record.
Measured: 12 months
Incidence of major depression patients registered in the electronical clinical record.
Measured: 18 months
Rates of suicide and suicide attempts
Measured: 18 months
Total health cost of depression
Direct and indirect health cost of major depression patients registered in electronical clinical record
Measured: 18 months
Total referrals to mental health specialists
Measured: 6 months
Total referrals to mental health specialists
Measured: 12 months
Total referrals to mental health specialists
Measured: 18 months
Use Rate of the recommended antidepressives for the guideline
Measured: 6 months
Use Rate of the recommended antidepressives for the guideline
Measured: 12 months
Use Rate of the recommended antidepressives for the guideline
Measured: 18 months
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
Measured: 6 months
Rate of patients in clinical remission
Measured: 12 months
Rate of patients in clinical remission
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital Clinic of Barcelona, Institut Catala de Salut
- Responsible party
- Principal investigator, Diego J. Palao-VIdal, Corporacion Parc Tauli
- Investigators
- Diego J Palao, Principal investigator, Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328833
- Sponsor's protocol ID
- SM-CSPT-DP2014-01
- Acronym
- GPC-DEPc
- Status last verified
- Dec 2014
- First submitted
- 29 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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 25500093Fernandez 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 20302995Serrano-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 19452110Pamias 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 22055213Weinmann 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 17498153Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.
PubMed 17051309
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
- ClinicalTrials.gov ID
- NCT02328833
- Acronym / sponsor ID
- GPC-DEPc / SM-CSPT-DP2014-01
- Conditions
- Depression
- Keywords
- Depression, Clinical Practice Guideline, Implementation, Primary Care, Computerized Guideline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital Clinic of Barcelona, Institut Catala de Salut
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Implementation of Guidelines | Experimental | Other: Experimental strategies of guidelines implementationPrimary Care Centers where the experimental strategies of guidelines implementation will be done |
| No Active Implementation of Guidelines | No intervention | –Primary Care Centers where the experimental strategies of guidelines implementation not will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental strategies of guidelines implementationExperimental 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. | Other | Active Implementation of Guidelines |
Primary outcome
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).
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time frame: 6 months
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time frame: 12 months
The rate of patients in which the instruments from the Computerized Depression Guideline were used.
Time frame: 18 months
14 secondary outcomes
Incidence of major depression patients registered in the electronical clinical record.
Time frame: 6 months
Incidence of major depression patients registered in the electronical clinical record.
Time frame: 12 months
Incidence of major depression patients registered in the electronical clinical record.
Time frame: 18 months
Rates of suicide and suicide attempts
Time frame: 18 months
Total health cost of depression
Time frame: 18 months
Total referrals to mental health specialists
Time frame: 6 months
Total referrals to mental health specialists
Time frame: 12 months
Total referrals to mental health specialists
Time frame: 18 months
Use Rate of the recommended antidepressives for the guideline
Time frame: 6 months
Use Rate of the recommended antidepressives for the guideline
Time frame: 12 months
Use Rate of the recommended antidepressives for the guideline
Time frame: 18 months
Rate of patients in clinical remission
Time frame: 6 months
Rate of patients in clinical remission
Time frame: 12 months
Rate of patients in clinical remission
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Background: PubMed 25500093Trinanes 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.
- Background: PubMed 20302995Fernandez 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.
- Background: PubMed 19452110Serrano-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.
- Background: PubMed 22055213Pamias 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.
- Background: PubMed 17498153Weinmann 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.
- Background: PubMed 17051309Sonnenberg FA, Hagerty CG. Computer-interpretable clinical practice guidelines. Where are we and where are we going ? Yearb Med Inform. 2006:145-58.
- Clinical Practice Guideline for Depression in Adults Patients of the National Health Spanish System (2014)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego J Palao principal investigator
Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)
Questions about this trial
What is this clinical trial studying?
A study testing Experimental strategies of guidelines implementation in people with Depression, run by Corporacion Parc Tauli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego J Palao (0034937458376, dpalao@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients in which the instruments from the Computerized Depression Guideline were used. (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328833, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.