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

September 14, 2017 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: INDI Implementation
Primary care centres which will implement the collaborative (INDI) care model for depression
Other: Intervention: INDI Implementation
Implementation of a collaborative care model in the context of primary care to manage depression
Other Names:
  • INDI
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of implementation and capacity for change of the collaborative care model (INDI)
Time Frame: 12 months
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)
12 months
patient experience about the collaborative care model (INDI)
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Investigators

  • Principal Investigator: Enric Aragonès, PhD, Jordi Gol Fundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P17/077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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