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Development and Assessment of the Implementation of a Collaborative Care Approach for Depression in Primary Care

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention: INDI Implementation
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring depression, Primary Health Care, Health Plan Implementation, Collaborative care, Patient-Centered Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
  • Organization: no exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention: INDI Implementation

    Control: no INDI implementation

    Arm Description

    Primary care centres which will implement the collaborative (INDI) care model for depression

    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

    Outcomes

    Primary Outcome Measures

    degree of implementation and capacity for change of the collaborative care model (INDI)
    degree of implementation of the collaborative care model (INDI) in health organization and professionals using the Assessment of Readiness for Chronicity in Health Care Organizations (ARCHO)
    patient experience about the collaborative care model (INDI)
    how patients experience depression care according to the collaborative care model (INDI) using the Instrument for Evaluating Patient Experience of Chronic Illness Care (IEXPAC) scale

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2017
    Last Updated
    September 14, 2017
    Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03285659
    Brief Title
    Development and Assessment of the Implementation of a Collaborative Care Approach for Depression in Primary Care
    Official Title
    Study Protocol: Development and Assessment of an Active Strategy for the Implementation of a Collaborative Care Approach for Depression in Primary Care. The INDI·i Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    depression, Primary Health Care, Health Plan Implementation, Collaborative care, Patient-Centered Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention: INDI Implementation
    Arm Type
    Experimental
    Arm Description
    Primary care centres which will implement the collaborative (INDI) care model for depression
    Arm Title
    Control: no INDI implementation
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Intervention: INDI Implementation
    Other Intervention Name(s)
    INDI
    Intervention Description
    Implementation of a collaborative care model in the context of primary care to manage depression
    Primary Outcome Measure Information:
    Title
    degree of implementation and capacity for change of the collaborative care model (INDI)
    Description
    degree of implementation of the collaborative care model (INDI) in health organization and professionals using the Assessment of Readiness for Chronicity in Health Care Organizations (ARCHO)
    Time Frame
    12 months
    Title
    patient experience about the collaborative care model (INDI)
    Description
    how patients experience depression care according to the collaborative care model (INDI) using the Instrument for Evaluating Patient Experience of Chronic Illness Care (IEXPAC) scale
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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 Organization: no exclusion criteria
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catarina Pires, PhD
    Phone
    0034 652957478
    Email
    jamnista@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Enric Aragonès, PhD
    Organizational Affiliation
    Jordi Gol Fundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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