Integrated Depression Care

Study Overview
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Brief Summary
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The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

Detailed Description
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The following deliverables apply: Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels; Training module for physicians and other care providers in population health management for patients with depression; Training module for case managers/integration of a case management function into existing depression service offerings; A patient education module for depression self-management; A financing model for integrated depression care.

Official Title
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Integrated Depression Care Project

Conditions
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Depression Mild, Depression Moderate, Depression Severe

Intervention / Treatment
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* Other: Integrated care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persons between 18-65 presenting to the general practitioner's office with depressive symtomatology Exclusion Criteria: Severe depression warranting direct referral to specialized services Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Pre/Posttest implementation study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated care arm<br>Case management in primary care setting (integration at general practitioners' practices), Depression and population management education for general practitioners, shared care guidance protocol including a medication path (drug classes, no specific drugs specified, based on available depression guidelines in Belgium). | Other: Integrated care<br>* The intervention will be modelled based on the most frequently reported patient, family physician and specialist barriers in depression management. In this project, multiple interventions aiming to tackle these barriers will be set up, with the WHO Framework on Integrated People-Centred Health Services (IPCHS) serving as conceptual backbone to the study (Table 1). The IPCHS distinguishes five interdependent strategies supporting a shift in healthcare delivery, management and funding towards universal health coverage. These strategies are: empowering and engaging people and communities; strengthening governance and accountability; reorienting the model of care; coordinating services within and across sectors; creating an enabling environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention integration | Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews. | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | PHQ-9 (Patient Health Questionnaire. DSM-5 depression), A PHQ-9 score total of 0-4 points equals normal or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression | 12 months | 
| Depression and anxiety | OQ-45-2 (Outcome Questionnaire. Transdiagnostical instrument focused on anxiety and depression) Total Score Total scores (≥ 64) reflect increased distress High is anything above 105 Moderately High is between 83 and 105 Moderate is between 64 and 82 Low is anything below 64 Symptom Distress (SD) Scores (≥ 37) indicate subjective discomfort Interpersonal Relations (IR) Scores (≥ 16) reflect problems in interpersonal relations. Social Role (SR) Scores (≥ 13) indicate dissatisfaction, conflict, distress, and inadequacy in performance of tasks related to employment, school, family roles and leisure life. | 12 months | 
| Medication adherence and self-efficacy | MARS-5 (Medication adherence report score) Each item was rated on a 5-point Likert scale, and the range of the MARS-5 total score is between 5 and 25. A higher score on the MARS-5 represents better medication adherence. <21 suboptimal adherence. MUSE (Medication Understanding and Use Self-Efficacy Scale). Score 8-32. Higher scores are better. | 12 months | 
| Resource use | iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use | 12 months | 
| Health-related Quality of Life | EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health. | 12 months | 
| Health literacy | HLS-EU-Q16. Considering the HLS-EUQ16 score, three levels of health literacy were defined: - inadequate HL (0-8) - problematic HL (9-12) - adequate HL (13-16) | 12 months |