High Utilization / Heavy UseINTUKNCT06411951
Integrated Care After Repeated Psychiatric Hospital Stays - Evaluation of an Interdisciplinary Treatment Program
An observational study of High Utilization / Heavy Use and Psychiatric Hospitalization, run by Michael Rufer at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Utilization / Heavy Use, Psychiatric Hospitalization, Rehospitalization
- What is being tested?
- Participation in the INTUK care offer at Klinik Zugersee
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric patients with 4 or more inpatient admissions at Klinik Zugersee in the past 24 months.
Who may be able to join
- Psychiatric patients with 4 or more inpatient admissions at Klinik Zugersee in the past 24 months.
Who cannot join
- Age < 18 years.
- Lack of written informed consent.
- Incapability of judgement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Triaplus AG - Klinik Zugersee
Oberwil, Canton of Zug, 6317
About this study
Official title: Integrated Care After Repeated Psychiatric Hospital Stays (INTUK) - Evaluation of an Interdisciplinary Treatment Program
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.
Read the detailed 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.
- Conditions
- High Utilization / Heavy Use, Psychiatric Hospitalization, Rehospitalization, Intensive Care Psychiatric Disorder, Chronic Psychiatric Disorder, Health Care Utilization
- Being tested
- Participation in the INTUK care offer at Klinik Zugersee
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in the INTUK care offer at Klinik ZugerseeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission rate
Participation in the INTUK program will be associated with a significant change in the total number of inpatient admissions.
Measured: 01.06.2023 - 31.05.2027
Secondary outcomes (4)
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).
Measured: 01.06.2023 - 31.05.2027
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).
Measured: 01.06.2023 - 31.05.2027
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).
Measured: 01.06.2023 - 31.05.2027
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).
Measured: 01.06.2023 - 31.05.2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jun 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Utilization / Heavy UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Rufer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Michael Rufer, Triaplus AG Klinik Zugersee - Zentrum für Psychiatrie und Psychotherapie
- Investigators
- Michael Rufer, Prof. Dr., Principal investigator, Triaplus AG - Klinik Zugersee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411951
- Sponsor's protocol ID
- 2023-00836
- Other IDs
- 2023
- Acronym
- INTUK
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care After Repeated Psychiatric Hospital Stays (INTUK) - Evaluation of an Interdisciplinary Treatment Program
- ClinicalTrials.gov ID
- NCT06411951
- Acronym / sponsor ID
- INTUK / 2023-00836
- Conditions
- High Utilization / Heavy Use, Psychiatric Hospitalization, Rehospitalization, Intensive Care Psychiatric Disorder, Chronic Psychiatric Disorder, Health Care Utilization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Michael RuferUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric patients with 4 or more inpatient admissions at Klinik Zugersee in the past 24 months.
Key inclusion criteria (1 listed)
- Psychiatric patients with 4 or more inpatient admissions at Klinik Zugersee in the past 24 months.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Lack of written informed consent.
- Incapability of judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in the INTUK care offer at Klinik ZugerseePerson-centered treatment and care tailored to the individual patients needs by a team consisting of a senior physician, a nurse, social workers and peers. | Other | – |
Primary outcome
Admission rate
Time frame: 01.06.2023 - 31.05.2027
Participation in the INTUK program will be associated with a significant change in the total number of inpatient admissions.
4 secondary outcomes
Length of hospital stays
Time frame: 01.06.2023 - 31.05.2027
Treatment effects
Time frame: 01.06.2023 - 31.05.2027
Treatment effects
Time frame: 01.06.2023 - 31.05.2027
Treatment effects
Time frame: 01.06.2023 - 31.05.2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Rufer, Prof. Dr. principal investigator
Triaplus AG - Klinik Zugersee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Utilization / Heavy Use and Psychiatric Hospitalization, run by Michael Rufer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission rate (time frame: 01.06.2023 - 31.05.2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.