Development and Assessment of the Implementation of a Collaborative Care Approach for Depression in Primary Care
NCT ID: NCT03285659
Last Updated: 2017-09-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-01
Study Completion Date
2019-12-31
Brief Summary
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Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in depression diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. It is intended to be implemented in clinical practice within the context of primary care.
Detailed Description
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BACKGROUND Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in its diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. INDI has been proved previously to be an efficient intervention showing clinical and socio-economic benefits. INDI is intended to be implemented in the clinical practice within the context of primary care.
METHOD Aim: Test the feasibility and the impact of an implementation strategy of the INDI model for the management of depression in primary care.
Design: This is a casi-experimental study within the context of primary care. Specific geographic areas will be identified to implement the INDI program (intervention group) and other areas with similar features will to be compared (control group.
Participants: Patients diagnosed with depression will be invited to voluntarily participate in this study. Additionally, the investigators will also consider as participants the health professionals, the centres of primary care, as well as the health organizations of the geographic areas where the study will take place: Camp de Tarragona and Valles Occidental (Catalonia, Spain).
Intervention: The INDI model is a health care program for improving the management of depression. INDI includes clinical, training and organizational interventions with the participation of nurses as care managers. An active strategy based on the Promoting Action on Research Implementation in Health Services's model (PARIHS) will be designed for the implementation.
Evaluation: This study will use qualitative and quantitative methods to obtain data on the variables related to a successful implementation: feasibility, acceptability, and impact.
Discussion: In this study, the investigators aim to test the feasibility of a clinical intervention INDI, based on a collaborative care model, in the management of depression in primary care setting. If the implementation of such intervention is successful, then the achieved data and experience will help to plan a strategy to generalize the INDI model to the Catalan health system. The investigators expect significant clinical benefits to the patients, the health system and to the society.
METHOD Aim: Test the feasibility and the impact of an implementation strategy of the INDI model for the management of depression in primary care.
Design: This is a casi-experimental study within the context of primary care. Specific geographic areas will be identified to implement the INDI program (intervention group) and other areas with similar features will to be compared (control group.
Participants: Patients diagnosed with depression will be invited to voluntarily participate in this study. Additionally, the investigators will also consider as participants the health professionals, the centres of primary care, as well as the health organizations of the geographic areas where the study will take place: Camp de Tarragona and Valles Occidental (Catalonia, Spain).
Intervention: The INDI model is a health care program for improving the management of depression. INDI includes clinical, training and organizational interventions with the participation of nurses as care managers. An active strategy based on the Promoting Action on Research Implementation in Health Services's model (PARIHS) will be designed for the implementation.
Evaluation: This study will use qualitative and quantitative methods to obtain data on the variables related to a successful implementation: feasibility, acceptability, and impact.
Discussion: In this study, the investigators aim to test the feasibility of a clinical intervention INDI, based on a collaborative care model, in the management of depression in primary care setting. If the implementation of such intervention is successful, then the achieved data and experience will help to plan a strategy to generalize the INDI model to the Catalan health system. The investigators expect significant clinical benefits to the patients, the health system and to the society.
Conditions
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Depression
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Intervention: INDI Implementation
Primary care centres which will implement the collaborative (INDI) care model for depression
Group Type
EXPERIMENTAL
Intervention: INDI Implementation
Intervention Type
OTHER
Implementation of a collaborative care model in the context of primary care to manage depression
Control: no INDI implementation
Primary care centres in which the collaborative care strategy INDI will not be implemented, but will be compared in terms of their clinical practice towards depression
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Intervention: INDI Implementation
Implementation of a collaborative care model in the context of primary care to manage depression
Intervention Type
OTHER
Other Intervention Names
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INDI
Eligibility Criteria
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Inclusion Criteria
* Patients: adult patients with a new diagnosis of depression or a new episode of antidepressant treatment. The comorbidity of depression with other common mental disorders such as anxiety disorders or somatization disorders is not an exclusion criterion.
* Organization: Health centres (i.e. Primary care centres) of Catalonia, which are comparable in terms of their sociodemographic, healthy and organizational features
* Organization: Health centres (i.e. Primary care centres) of Catalonia, which are comparable in terms of their sociodemographic, healthy and organizational features
Exclusion Criteria
* Patients: adult patients with a diagnosis of psychotic or bipolar disorder, drug or alcohol use disorder, dementia, intellectual disability, postpartum depression, and patients included in the home care program
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Enric Aragonès, PhD
Role: PRINCIPAL_INVESTIGATOR
Jordi Gol Fundation
Central Contacts
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References
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Aragones E, Pinol JL, Labad A, Masdeu RM, Pino M, Cervera J. Prevalence and determinants of depressive disorders in primary care practice in Spain. Int J Psychiatry Med. 2004;34(1):21-35. doi: 10.2190/C25N-W4NY-BN8W-TXN2.
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Aragones E, Pinol JL, Caballero A, Lopez-Cortacans G, Casaus P, Hernandez JM, Badia W, Folch S. Effectiveness of a multi-component programme for managing depression in primary care: a cluster randomized trial. The INDI project. J Affect Disord. 2012 Dec 15;142(1-3):297-305. doi: 10.1016/j.jad.2012.05.020. Epub 2012 Oct 11.
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Aragones E, Caballero A, Pinol JL, Lopez-Cortacans G. Persistence in the long term of the effects of a collaborative care programme for depression in primary care. J Affect Disord. 2014 Sep;166:36-40. doi: 10.1016/j.jad.2014.05.003. Epub 2014 May 11.
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BACKGROUND
Aragones E, Caballero A, Pinol JL, Lopez-Cortacans G, Badia W, Hernandez JM, Casaus P, Folch S, Basora J, Labad A; INDI research group. Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement). BMC Public Health. 2007 Sep 20;7:253. doi: 10.1186/1471-2458-7-253.
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Aragones E, Lopez-Cortacans G, Sanchez-Iriso E, Pinol JL, Caballero A, Salvador-Carulla L, Cabases J. Cost-effectiveness analysis of a collaborative care programme for depression in primary care. J Affect Disord. 2014 Apr;159:85-93. doi: 10.1016/j.jad.2014.01.021. Epub 2014 Feb 13.
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Aragones E, Lopez-Cortacans G, Cardoner N, Tome-Pires C, Porta-Casteras D, Palao D; INDI.I Research Team. Barriers, facilitators, and proposals for improvement in the implementation of a collaborative care program for depression: a qualitative study of primary care physicians and nurses. BMC Health Serv Res. 2022 Apr 5;22(1):446. doi: 10.1186/s12913-022-07872-z.
Reference Type
DERIVED
Aragones E, Palao D, Lopez-Cortacans G, Caballero A, Cardoner N, Casaus P, Cavero M, Monreal JA, Perez-Sola V, Cirera M, Loren M, Bellerino E, Tome-Pires C, Palacios L. Development and assessment of an active strategy for the implementation of a collaborative care approach for depression in primary care (the INDI.i project). BMC Health Serv Res. 2017 Dec 13;17(1):821. doi: 10.1186/s12913-017-2774-2.
Reference Type
DERIVED
Other Identifiers
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P17/077
Identifier Type: -
Identifier Source: org_study_id