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

Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorder
• Intervention / Treatment: Behavioral: Early assessment team; Behavioral: Admission to General psychiatric outpatient clinic

• Study Type: Interventional
• Enrollment (Estimated): 588
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrine H Holgersen, phd; Phone Number: +4772829000; Email: Katrine.Hoyer.Holgersen@stolav.no
• Study Contact Backup: Name: Camilla Angelsen Kvestad, MD; Email: camilla.kvestad@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • Nidelv DPS, Tiller

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early assessment group	Behavioral: Early assessment team; 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.
Active Comparator: Usual admission procedure group	Behavioral: Admission to General psychiatric outpatient clinic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2, 4, 8, 12, 24 months after enrollment
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.	2, 4, 8, 12, 24 months after enrollment
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.	Through study completion, an average of 1 year
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).	12, 24 months after enrollment
Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)	A self-administered short form of CORE-OM (see outcome 5) with 10 items	2, 4, 8 months after enrollment
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).	2, 4, 8, 12, 24 months after enrollment
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.	12 and 24 months
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.	2, 4, 8, 24 months after enrollment

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Chair: Jon Helle, MD, Nidelv DPS, Tiller, St.Olavs hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 244508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No