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Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care (GPC-DEPc)

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ClinicalTrials.gov Identifier: NCT02328833
Recruitment Status : Unknown
Verified December 2014 by Diego J. Palao-VIdal, Corporacion Parc Tauli.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Hospital Clinic of Barcelona
Institut Catala de Salut
Information provided by (Responsible Party):
Diego J. Palao-VIdal, Corporacion Parc Tauli

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.

Condition or disease Intervention/treatment Phase
Depression Other: Experimental strategies of guidelines implementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care
Study Start Date : January 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Implementation of Guidelines
Primary Care Centers where the experimental strategies of guidelines implementation will be done
Other: Experimental 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.

No Intervention: No Active Implementation of Guidelines
Primary Care Centers where the experimental strategies of guidelines implementation not will be done



Primary Outcome Measures :
  1. 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).

  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 Outcome Measures :
  1. 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.

  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 [ Time Frame: 18 months ]
    Direct and indirect health cost of major depression patients registered in electronical clinical record

  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 [ Time Frame: 6 months ]
    The clinical remission of depression symptoms is defined by a Patient Health Questionnaire-9 (PHQ-9) Score of < 5 points

  13. Rate of patients in clinical remission [ Time Frame: 12 months ]
  14. Rate of patients in clinical remission [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328833


Contacts
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Contact: Diego J Palao 0034937458376 dpalao@tauli.cat

Sponsors and Collaborators
Corporacion Parc Tauli
Instituto de Salud Carlos III
Hospital Clinic of Barcelona
Institut Catala de Salut
Investigators
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Principal Investigator: Diego J Palao Corporacion Parc Taulí Sabadell, University Hospital (Barcelona, Spain)
Additional Information:
Publications:

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Responsible Party: Diego J. Palao-VIdal, Mental Health Director, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02328833    
Other Study ID Numbers: SM-CSPT-DP2014-01
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Diego J. Palao-VIdal, Corporacion Parc Tauli:
Depression
Clinical Practice Guideline
Implementation
Primary Care
Computerized Guideline
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders