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

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
SGE-PsyScan
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stichting Gezondheidscentra Eindhoven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SGE-PsyScan

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

The level of psychosocial symptoms of patients as measured with the SCL-90
The level of psychosocial symptoms of patients as measured with the SCL-90
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
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
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
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
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
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.

Full Information

First Posted
October 11, 2013
Last Updated
December 21, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Stichting Gezondheidscentra Eindhoven (SGE), Stichting Volksgezondheidszorg (VGZ), Zorgverzekeraar CZ
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1. Study Identification

Unique Protocol Identification Number
NCT01971307
Brief Title
Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.
Acronym
SGE-PsyScan
Official Title
Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Stichting Gezondheidscentra Eindhoven (SGE), Stichting Volksgezondheidszorg (VGZ), Zorgverzekeraar CZ

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGE-PsyScan
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SGE-PsyScan
Primary Outcome Measure Information:
Title
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%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The level of psychosocial symptoms of patients as measured with the SCL-90
Time Frame
3 months
Title
The level of psychosocial symptoms of patients as measured with the SCL-90
Time Frame
6 months
Title
Health technology assessment
Description
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
Time Frame
3 months
Title
Health technology assessment
Description
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
Time Frame
6 months
Title
Health technology assessment
Description
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
Time Frame
9 months
Title
Health technology assessment
Description
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
Time Frame
12 months
Title
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
Time Frame
3 months
Title
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
Time Frame
6 months
Title
Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire
Time Frame
12 months
Title
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
Time Frame
3 months
Title
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
Time Frame
6 months
Title
The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)
Time Frame
12 months
Title
Electronic medical records parameters
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Health care provider satisfaction with the Assessment of Chronic Illness Care (ACIC)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark G Spigt, PhD
Organizational Affiliation
Research Institute CAPHRI, Department of Family Medicine, Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stichting Gezondheidscentra Eindhoven
City
Eindhoven
ZIP/Postal Code
5605 LS
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29255109
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.
Results Reference
derived

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Supporting Primary Care in Diagnosis and Choice of Treatment for Patients With Psychosocial Symptoms: SGEPsyScan.

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