Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan. (SGE-PsyScan)

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Other: SGE-PsyScan

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands, 5605 LS
    • Stichting Gezondheidscentra Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGE-PsyScan; The SGE-PsyScan is an internet application to which the General Practitioner (GP) refers the patient, which includes the distress screener, the 4-Dimensional Symptom Questionnaire (4DSQ) and a series of additional questions for differentiating between stress, depressive, anxious and somatization symptoms. Based on the 4DSQ patients and GPs receive advices for possible treatments.	Other: SGE-PsyScan
No Intervention: Usual care; Usual care for persons with psychosocial symptoms and disorders in Dutch primary care includes all usual care procedures; preventive, screening, diagnostic, (non-)pharmacological or therapeutic procedures which are routinely used in everyday care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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%.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of psychosocial symptoms of patients as measured with the SCL-90		3 months
The level of psychosocial symptoms of patients as measured with the SCL-90		6 months
Health technology assessment	We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals	3 months
Health technology assessment	We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals	6 months
Health technology assessment	We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals	9 months
Health technology assessment	We will measure direct and indirect costs in both groups with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) and Electronic Medical Records (EMR) parameters indicating relevant expenditures including treatments, consultations and referrals	12 months
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		3 months
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		6 months
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		12 months
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		3 months
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		6 months
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		12 months
Electronic medical records parameters	Relevant psychosocial care parameters will be extracted from the EMR to monitor changes in care patterns including previous psychosocial episodes, numbers and types of psychosocial diagnoses, use of screening/diagnostic instruments, comorbidity, treatments, medication prescriptions, referrals and health care consumption.	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Health care provider satisfaction with the Assessment of Chronic Illness Care (ACIC)	12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Zorgverzekeraar CZ; Stichting Gezondheidscentra Eindhoven (SGE); Stichting Volksgezondheidszorg (VGZ)
• Investigators: Principal Investigator: Mark G Spigt, PhD, Research Institute CAPHRI, Department of Family Medicine, Maastricht University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: NL44597.068.13/ METC 13-3-034