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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06411951
Other study ID # 2023-00836
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source Triaplus AG Klinik Zugersee - Zentrum für Psychiatrie und Psychotherapie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to evaluate the treatment effects as well as inhibiting and promoting factors in the implementation of the new INTUK care offer in a sample of "heavy users", i.e. psychiatric patients with 4 or more prior inpatient admissions at Klinik Zugersee, by means of a longitudinal, prospective-retrospective study. For this purpose, medical records will be analysed and participants will be asked to fill out questionnaires addressing different aspects of mental health, quality of life and patient satisfaction. In addition, semi-structured interviews will be conducted with a subset of patients as well as staff members of the INTUK care offer.


Description:

In the mental health literature, the terms "heavy users" or "high utilizers" have been coined to describe a relatively small group of people with chronic mental illness, with excess use of inpatient psychiatric services. Although these terms are used both nationally and internationally, there is no consensus on how they are defined. For example, in Switzerland, they are used by the Swiss Health Observatory (Obsan) and the Federal Office of Public Health. Previous research suggests that even though only 10% to 30% of all inpatients qualify as "heavy users", their use of the healthcare system's resources is well above average. In German-speaking countries, there are currently only a few scientific studies on this group of patients, especially on the question of which offers are best suited to better integrate existing models of care, and how to make them more effective. Due to the separate enumeration of outpatient and inpatient care in Switzerland (as in many other countries), integrated models of care that are particularly needed for this group of patients are currently lacking. This can result in costly under- and incorrect treatment with more frequent discontinuations. In addition, apart from the treatment of medical issues, other aspects often play an important role in the care of chronically ill patients, such as socio-economic difficulties (e.g. in the areas of work and housing or financial problems). Therefore, in the recently completed National Research Program (NRP) 74 "Healthcare" of the Swiss National Science Foundation, the numerous interfaces between care settings were identified as a central field of action, which is a particularly the case in patients with chronic illnesses: "In the highly specialized, decentralized health care system in Switzerland, coordination between multiple medical and non-medical services is difficult." INTUK (Integrated care after repeated psychiatric hospital stays) represents a new interprofessional and integrated care program at Klinik Zugersee, which aims to bridge such interfaces and improve the treatment of people with chronically recurrent mental illness. A team consisting of a senior physician, nurse, social worker, and peer will deliver person-centered care tailored to individual needs in these mostly complex care situations. Contact is initiated with the affected patients during their inpatient stay to build relationships and increase motivation for subsequent, individually planned treatment and care. For example, round-table discussions can take place with the specialists and community-based providers involved in the follow-up treatment before the patient is discharged. After discharge, the same team continues to provide support and coordinate access to outpatient and semi-inpatient treatment, counselling and self-help services. In the case of social difficulties, social work coaching or accompaniment to offices and social institutions takes place will be provided. Another service is the joint drafting of a psychiatric living will to determine consent and rejection for future psychiatric treatments. Wherever possible, close others and the wider social environment are also included in consultation with the patient.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 90
Est. completion date December 31, 2027
Est. primary completion date May 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Psychiatric patients with 4 or more inpatient admissions at Klinik Zugersee in the past 24 months. Exclusion Criteria: - Age < 18 years. - Lack of written informed consent. - Incapability of judgement.

Study Design


Intervention

Other:
Participation in the INTUK care offer at Klinik Zugersee
Person-centered treatment and care tailored to the individual patients needs by a team consisting of a senior physician, a nurse, social workers and peers.

Locations

Country Name City State
Switzerland Triaplus AG - Klinik Zugersee Oberwil Zug

Sponsors (2)

Lead Sponsor Collaborator
Michael Rufer University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Admission rate Participation in the INTUK program will be associated with a significant change in the total number of inpatient admissions. 01.06.2023 - 31.05.2027
Secondary Length of hospital stays Participation in the INTUK program will be associated with a change in the total length of hospital stays (measured in days). 01.06.2023 - 31.05.2027
Secondary Treatment effects Participation in the INTUK program will be associated with a significant change in the impairment due to psychiatric symptoms measured using the Symptom-Checkliste-K-9 (SCL-9-K; on a numeric scale from 9 to 36; higher indicating a worse outcome). 01.06.2023 - 31.05.2027
Secondary Treatment effects Participation in the INTUK program will be associated with a significant change in the quality of life measured using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF; on a numeric scale of 0 to 100, lower indicating a worse outcome). 01.06.2023 - 31.05.2027
Secondary Treatment effects Participation in the INTUK program will be associated with a significant change in the severity of the mental illness measured using the Global Clinical Impression Scale (CGI; on a numeric scale from 1 to 7; higher indicating a worse outcome). 01.06.2023 - 31.05.2027
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