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

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03285659
• Other study ID #: P17/077
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2017
• Last updated: September 14, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2017
• Source: Jordi Gol i Gurina Foundation
• Contact: Catarina Pires, PhD
• Phone: 0034 652957478
• Email: jamnista[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Intervention: INDI Implementation
Implementation of a collaborative care model in the context of primary care to manage depression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

References & Publications (32)

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Aragonès E, Piñol JL, Caballero A, López-Cortacans G, Casaus P, Hernández 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. — View Citation

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Solberg LI, Asche SE, Margolis KL, Whitebird RR. Measuring an organization's ability to manage change: the change process capability questionnaire and its use for improving depression care. Am J Med Qual. 2008 May-Jun;23(3):193-200. doi: 10.1177/1062860608314942. — View Citation

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Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99. — View Citation

Thota AB, Sipe TA, Byard GJ, Zometa CS, Hahn RA, McKnight-Eily LR, Chapman DP, Abraido-Lanza AF, Pearson JL, Anderson CW, Gelenberg AJ, Hennessy KD, Duffy FF, Vernon-Smiley ME, Nease DE Jr, Williams SP; Community Preventive Services Task Force. Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. Am J Prev Med. 2012 May;42(5):525-38. doi: 10.1016/j.amepre.2012.01.019. Review. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Primary	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	12 months