Clinical trial NCT01971307: Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.
Official title: Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Gezondheidscentra Eindhoven (SGE)
name: Stichting Volksgezondheidszorg (VGZ)
name: Zorgverzekeraar CZ
First posted: 2013-10-29
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although effective treatments for psychosocial symptoms and disorders are available, patients frequently do not receive the most appropriate and effective treatment for their symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in general practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in usual care. As a result, patients are supposed to start earlier with a treatment that fits the type and severity of their symptoms better.

The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.


Eligibility criteria: Inclusion Criteria:

* Patients with (suspected) psychosocial symptoms
* Aged 18 years or older and capacitated
* Adequate understanding of Dutch language
* Able to perform SGE-PsyScan at home, individually

Exclusion Criteria:

* Clear and treatable somatic causes of symptoms
* Acute distress/danger
* No written informed consent

Primary outcomes:
measure: The rate of patients who achieve a successful decrease in the level of psychosocial symptoms as measured with the Symptom Checklist 90 (SCL-90) after 12 months. A successful treatment result is defined as a decrease in the SCL-90 patient score of 50%.
timeFrame: 12 months
Secondary outcomes:
measure: The level of psychosocial symptoms of patients as measured with the SCL-90
timeFrame: 3 months
measure: The level of psychosocial symptoms of patients as measured with the SCL-90
timeFrame: 6 months
measure: Health technology assessment
timeFrame: 3 months
measure: Health technology assessment
timeFrame: 6 months
measure: Health technology assessment
timeFrame: 9 months
measure: Health technology assessment
timeFrame: 12 months
measure: Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
timeFrame: 3 months
measure: Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
timeFrame: 6 months
measure: Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
timeFrame: 12 months
measure: The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 3 months
measure: The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 6 months
measure: The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 12 months
measure: Electronic medical records parameters
timeFrame: 12 months
Other outcomes:
measure: Health care provider satisfaction with the Assessment of Chronic Illness Care (ACIC)
timeFrame: 12 months
Locations:
city: Eindhoven
country: Netherlands
facility: Stichting Gezondheidscentra Eindhoven
Study officials:
affiliation: Research Institute CAPHRI, Department of Family Medicine, Maastricht University
name: Mark G Spigt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gidding LG, Spigt M, Winkens B, Herijgers O, Dinant GJ. PsyScan e-tool to support diagnosis and management of psychological problems in general practice: a randomised controlled trial. Br J Gen Pract. 2018 Jan;68(666):e18-e27. doi: 10.3399/bjgp17X694109. Epub 2017 Dec 18.