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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Depression

Treatments: Other: GP-targeted feedback; Other: Patient-targeted feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03988985

UHHamburgEppendorfGetFeedback

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,030 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,030 participants in 3 patient groups

PATIENT-GP-FEEDBACK

Experimental group

Description:

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.

Treatment:

Other: GP-targeted feedback

Other: Patient-targeted feedback

GP-FEEDBACK

Active Comparator group

Description:

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.

Treatment:

Other: GP-targeted feedback

NO-FEEDBACK

No Intervention group

Description:

Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback.