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
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
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
NCT ID
NCT03285659
First Posted
September 12, 2017
Last Updated
September 14, 2017
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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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Development and Assessment of the Implementation of a Collaborative Care Approach for Depression in Primary Care
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