Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices

Study Overview
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Brief Summary
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The multi-center GET.FEEDBACK.GP randomized controlled trial is designed based on patients' needs and preferences. In order to evaluate the effect of feedback in the broader setting of primary care, a total of 1076 primary care patients with elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) patient-targeted and physician-targeted feedback of depression screening results, b) a physician-targeted feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' behavior and cognitions after the screening, depression care according to German guideline recommendations and the health economic evaluation.

Detailed Description
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Major depression is one of the most significant clinical disorders. In primary care, every sixth patient suffers from increased depression level, which is associated with higher risk of suicide, increased risk of onset and progression of chronic physical conditions. Still, depression is under recognized and undertreated in primary care. Moreover, evidence regarding the efficacy of depression screening in primary care is insufficient to draw clear conclusions. Our previous mono-center depression screening trial in cardiac patients, provides first evidence that written patient-targeted feedback improves depression severity, encourages greater patient participation and engagement in mental health. To amplify these effects, the multi-center GET.FEEDBACK.GP randomized controlled trial is now designed based on patients' needs and preferences. In order to evaluate the effect of feedback in the broader setting of primary care, a total of 1076 primary care patients with elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) patient-targeted and physician-targeted feedback of depression screening results, b) a physician-targeted feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' behavior and cognitions after the screening, depression care according to German guideline recommendations and the health economic evaluation.

Official Title
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Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Other: Patient-targeted feedback
* Other: GP-targeted feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender: male, female, diverse Maximum Age: no maximum age Attendance in primary care with medical consultation Age ≥ 18 years; Sufficient language skills; Informed consent Patient Health Questionnaire-9 > 9 points Exclusion Criteria: Life threatening health status; Severe somatic or/and psychological disorder that needs urgent treatment; Known diagnosis of a depressive disorder Current depression treatment Acute suicidal tendency; Severe cognitive or/and visual difficulties; Not being able to fill out questionnaires No contact details

Ages Eligible for Study
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Minimum Age: 18 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: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATIENT-GP-FEEDBACK<br>Using a randomized-controlled study design one third of the patients and their attending general practitioner will receive feedback after depression screening. The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient. | Other: Patient-targeted feedback<br>* The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.<br>Other: GP-targeted feedback<br>* The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.<br>|
| Active Comparator: GP-FEEDBACK<br>Using a randomized-controlled study design in one third of the cases only the attending general practitioner will receive feedback after depression screening. The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient. | Other: GP-targeted feedback<br>* The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.<br>|
| No Intervention: NO-FEEDBACK<br>Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity (Questionnaire: Patient Health Questionnaire-9) | Level of depression severity six months after screening (Patient Health Questionnaire-9) | Six months after screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity (Questionnaire: Patient Health Questionnaire-9) | Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9) | One and twelve months after screening | 
| Depression treatment | Proportion of patients treated according to German Guideline based recommendations | Six and twelve months after screening | 
| Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory) | Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory) | Six and twelve months after screening | 
| Quality-adjusted life years (Questionnaire: EuroQol-5D) | Quality-adjusted years of life and quality of life (EuroQol-5D) | Six and twelve months after screening | 
| Anxiety (Questionnaire: Generalized Anxiety Disorder-7) | Level of anxiety severity one, six and twelve months after screening | One, six and twelve months after screening | 
| Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8) | Level of somatic symptom severity one, six and twelve months after screening | One, six and twelve months after screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Screening, Primary Care, General Practice, Feedback