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

Mental Disorders Clinical Trial

— SGE-PsyScan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971307
• Other study ID #: NL44597.068.13/ METC 13-3-034
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: December 21, 2015
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• SGE-PsyScan

Locations

Country	Name	City	State
Netherlands	Stichting Gezondheidscentra Eindhoven	Eindhoven

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Stichting Gezondheidscentra Eindhoven (SGE), Stichting Volksgezondheidszorg (VGZ), Zorgverzekeraar CZ

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care provider satisfaction with the Assessment of Chronic Illness Care (ACIC)		12 months	No
Primary	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	No
Secondary	The level of psychosocial symptoms of patients as measured with the SCL-90		3 months	No
Secondary	The level of psychosocial symptoms of patients as measured with the SCL-90		6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		3 months	No
Secondary	Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		6 months	No
Secondary	Quality of life will be measured using the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire		12 months	No
Secondary	The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		3 months	No
Secondary	The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		6 months	No
Secondary	The extent of patient satisfaction with the care they receive, will be measured using the Patient Assessment of Chronic Illness Care (PACIC)		12 months	No
Secondary	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	No