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Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

Primary Purpose

Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early assessment team
Admission to General psychiatric outpatient clinic
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • all patients referred to a general psychiatric outpatient clinic
  • necessary capacity to consent
  • master Norwegian language to such an extent that the patient can understand the written consent

Exclusion Criteria:

  • patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time
  • patients too healthy to receive specialized mental health care
  • patients in need of acute psychiatric assessment
  • relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines

Sites / Locations

  • Nidelv DPS, TillerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early assessment group

Usual admission procedure group

Arm Description

Outcomes

Primary Outcome Measures

Work and Social Adjustment Scale (WSAS)
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.

Secondary Outcome Measures

World Health Organization Well Being Index (WHO-5)
The World Health Organization Well Being Index is one of the most widely used measures of subjective psychological well-being that is also a measure of depression. The scale consists of 5 questions about participants well-being experienced during the past 2 weeks. Items are rated on a 6-point scale from 0 (never) to 5 (all the time).
EuroQoL EQ-5D-5L
EuroQoL EQ-5D-5L is used to measure health outcomes and perform health economic analyzes. The form consists of 5 questions covering walking, personal care, daily tasks, pain / discomfort and anxiety / depression. In addition, the patient must indicate their own state of health on a VAS scale from 0-100.
Client Satisfaction Questionnaire (CSQ-8)
The measure yields a continuous score on a single factor of general satisfaction. This is derived from eight questions about the quality of service, the kind of service, patients' outcomes and overall satisfaction. The scale is rated on a 4-point response scale.
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)
A self-administered questionnaire with 34 items related to the preceding week mapping 4 main areas; well-being (4 elements), problems (12 elements), function (12 elements) og risk (6 elements). All items are scored from "Never" (=0) to "Almost all the time" (=4).
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)
A self-administered short form of CORE-OM (see outcome 5) with 10 items
The Questionaire about the Process of Recovery (QPR-15)
The scale is used to capture peoples' accounts of recovery from severe mental illness. The 15-item version has been recommended for use both in routine clinical work and in research, and it is scored on a 5-point scale from 0 = disagree strongly to 4 = agree strongly).
Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)
The Norwegian Labour and Welfare Administration (NAV) have data on all citizens working status and sick leaves lasting for more than two weeks. Extracted data will include information such as sick- and disability leaves until 12 and 24 months after enrolment.
Work and Social Adjustment Scale (WSAS)
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.

Full Information

First Posted
September 13, 2021
Last Updated
October 28, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05087446
Brief Title
Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care
Official Title
Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition. With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence. The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
588 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early assessment group
Arm Type
Experimental
Arm Title
Usual admission procedure group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Early assessment team
Intervention Description
Early assessment team (EAT):The patients receive their first assessment by an early clarification team within a few weeks after the team receiving the referral. The team then decides whether further assessment and/or treatment should be given in the general outpatient clinic, and/or whether any other follow-up may be appropriate. In the first meeting the patient preferably meets two therapists, who conduct a semi-structured interview with focus on health and level of functioning. If considered appropriate, the team may offer a short-term intervention.
Intervention Type
Behavioral
Intervention Name(s)
Admission to General psychiatric outpatient clinic
Intervention Description
Ordinary procedures for admission to an outpatient clinic are followed in accordance with the Norwegian Directorate of Health's national prioritization guide. Referrals are assessed on the basis of severity and placed on a regular waiting list (usually a waiting period of 1-3 months). The patients receive their first personal assessment from a therapist in a general outpatient clinic who takes a position on what is to be initiated and, if necessary, offers further assessment / treatment in accordance with procedures in the outpatient clinics. This is not standardized beyond current practice.
Primary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS)
Description
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
World Health Organization Well Being Index (WHO-5)
Description
The World Health Organization Well Being Index is one of the most widely used measures of subjective psychological well-being that is also a measure of depression. The scale consists of 5 questions about participants well-being experienced during the past 2 weeks. Items are rated on a 6-point scale from 0 (never) to 5 (all the time).
Time Frame
2, 4, 8, 12, 24 months after enrollment
Title
EuroQoL EQ-5D-5L
Description
EuroQoL EQ-5D-5L is used to measure health outcomes and perform health economic analyzes. The form consists of 5 questions covering walking, personal care, daily tasks, pain / discomfort and anxiety / depression. In addition, the patient must indicate their own state of health on a VAS scale from 0-100.
Time Frame
2, 4, 8, 12, 24 months after enrollment
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
The measure yields a continuous score on a single factor of general satisfaction. This is derived from eight questions about the quality of service, the kind of service, patients' outcomes and overall satisfaction. The scale is rated on a 4-point response scale.
Time Frame
Through study completion, an average of 1 year
Title
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)
Description
A self-administered questionnaire with 34 items related to the preceding week mapping 4 main areas; well-being (4 elements), problems (12 elements), function (12 elements) og risk (6 elements). All items are scored from "Never" (=0) to "Almost all the time" (=4).
Time Frame
12, 24 months after enrollment
Title
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)
Description
A self-administered short form of CORE-OM (see outcome 5) with 10 items
Time Frame
2, 4, 8 months after enrollment
Title
The Questionaire about the Process of Recovery (QPR-15)
Description
The scale is used to capture peoples' accounts of recovery from severe mental illness. The 15-item version has been recommended for use both in routine clinical work and in research, and it is scored on a 5-point scale from 0 = disagree strongly to 4 = agree strongly).
Time Frame
2, 4, 8, 12, 24 months after enrollment
Title
Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)
Description
The Norwegian Labour and Welfare Administration (NAV) have data on all citizens working status and sick leaves lasting for more than two weeks. Extracted data will include information such as sick- and disability leaves until 12 and 24 months after enrolment.
Time Frame
12 and 24 months
Title
Work and Social Adjustment Scale (WSAS)
Description
WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.
Time Frame
2, 4, 8, 24 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients referred to a general psychiatric outpatient clinic necessary capacity to consent master Norwegian language to such an extent that the patient can understand the written consent Exclusion Criteria: patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time patients too healthy to receive specialized mental health care patients in need of acute psychiatric assessment relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine H Holgersen, phd
Phone
+4772829000
Email
Katrine.Hoyer.Holgersen@stolav.no
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Angelsen Kvestad, MD
Email
camilla.kvestad@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Helle, MD
Organizational Affiliation
Nidelv DPS, Tiller, St.Olavs hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nidelv DPS, Tiller
City
Trondheim
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

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