Home treatment for acute mental healthcare in Ticino, Switzerland

ISRCTN	ISRCTN38472626
DOI	https://doi.org/10.1186/ISRCTN38472626
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NRP74 407440_167375
Sponsor	Swiss National Science Foundation
Funder	Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Submission date: 29/10/2020
Registration date: 17/11/2020
Last edited: 20/06/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Crisis Resolution and Home Treatment (CRHT) teams represent a community-based mental health service offering a valid alternative to hospitalisation for short term mental illness. The evaluation of several home-treatment experiences shows promising results; however, it remains unclear which specific elements and characteristics of CRHT are more effective and acceptable. This study aims to assess the acceptability, effectiveness and cost-effectiveness of a new CRHT intervention in Ticino, Southern Switzerland.

Who can participate?
Patients aged 18 to 65 living in two districts of Southern Switzerland (“Bellinzona e Valli” versus “Lugano”) with diagnosis of acute mental illness requiring hospital admission and eligible for home treatment.

What does the study involve?
Patients in the northern area of the region will be offered the CRHT service and be defined as the intervention group; patients in the southern area of the region will act as the control group and receive care as usual for a 48 month period.
Individual interviews with patients receiving the home treatment intervention and their family members will be conducted. Participants will complete questionnaires and for some participants an interview of an hour. CRHT team members will also be interviewed.

What are the possible benefits and risks of participating?
No direct benefits or risks. Findings from this study will allow local services to improve their effectiveness in a challenging domain of public health and contribute to improving access to more effective care for people with severe mental disorders.

Where is the study run from?
Clinica Psichiatrica Cantonale (Switzerland)

When is the study starting and how long is it expected to run for?
March 2017 to May 2019

Who is funding the study?
Swiss National Science Foundation

Who is the main contact?
Rafael Traber,
rafael.traber@ti.ch

Contact information

Mr Rafael Traber
Public

Via Luganetto 5
Viganello
6976
Switzerland

Phone	+41 7624050 67
Email	rafael.traber@ti.ch

Study information

Primary study design	Interventional
Study design	Interventional non randomised quasi-experimental study
Secondary study design	Non randomised study
Participant information sheet	ISRCTN38472626_PIS_qualitative study_v1_25Oct2018.pdf
Scientific title	Home treatment for acute mental healthcare in Ticino: protocol of the Foresight study
Study acronym	Foresight
Study objectives	Crisis Resolution and Home Treatment (CRHT) teams representa a communitiy-based mental health service offering a valid alternative to hospitalisation. The evaluation of several home-treatment experiences shows promising results; however, it remains unclear which specific elements and caracteristics of CRHT are more effective and acceptable. This study aims to assess the acceptability, effectiveness and cost-effetiveness of a new CRHT intervention in Ticino, Southern Switzerland.
Ethics approval(s)	Approved 28/03/2017, Ethica Committee of the Canton Ticino (Ufficio di sanità, Via Orico 5, 6501 Bellinzona, Switzerland; +41 918143057; michaela.gutacker@ti.ch), ref: Basec 2017-00247
Health condition(s) or problem(s) studied	Acute mental illness requiring hospital admission to the psychiatric hospital
Intervention	Crisis Resolution Home Treatment (CRHT) arm: Patients from the Bellinzona area will typically be visited at home on a daily basis for approximately 1 h, with the option for multiple visits a day (or night) if necessary. Interventions will be individually tailored but include typical ingredients of acute care, such as crises intervention, pharmacotherapy, psychoeducation, brief psychotherapy and social care. The CRHT team base is situated in the heart of Bellinzona, where an existing community mental health team is already operating. The CRHT provides services for 14 patients, aged 18 -65 years who without the presence of the CRHT would be typically admitted to a psychiatric hospital on a voluntary basis. Staff are available 24 hours per day, 7 days a week. The service brings together different health and social care professionals, including three physicians, ten mental health nures, one team manager, one social worker and one clinical psychologist). The services offered by the home treatment team include all those provided by a multidisciplinary approach within an inpatient setting: providing daily reviews by nurses and psychiatrists, performing ad hoc physical examination, blood tests and ECGs in liaison with general medical practitioners, facilitating access to further physical health investigations and medical consultations via the local access and emergency department, refining diagnostic formulations, offering the possibility of neuropsychological assessments, prescribing and administering pharmacological treatment, actively monitoring compliance to prescribed medication, time structuring, psychoeducation with patients family and carers. Patients will typically be visited at home on a daily basis for approximately 1 h, with the option for multiple visits a day (or night) if necessary. Interventions will be individually tailored but include typical ingredients of acute care, such as crises intervention, pharmacotherapy, psychoeducation, brief psychotherapy and social care. Traditional inpatient treatment arm with patients from the Lugano area: Patients for the Lugano area will be admitted to a psychiatric hospital (CPC) with the presence of a mental health team (psychiatrists, mental health nurses, social worker and psychologist) 24 hour 7 days a week. They are treated by multidisciplinary approach providing multiple visits by nurses and psychiatrists, performing ad hoc physical examination, blood tests and ECGs in the hospital, facilitating access to further physical health investigations and medical consultations via the local access and emergency department, refining diagnostic formulations, offering the possibility of neuropsychological assessments, prescribing and administering pharmacological treatment, actively monitoring compliance to prescribed medication, time structuring by a team of sociotherapists, psychoeducation with patients family and carers and social care.
Intervention type	Behavioural
Primary outcome measure(s)	1. Number of inpatient days (taken from the patient record) be measured every six months during a two-year follow-up period 2. Total days in treatment and other service utilization (taken from the patient record) measured every six months during a two-year follow-up period 3. Direct cost (data will be delivered by the health insurance company) measured every six months during a two-year follow-up period 4. HoNOS Health of Nation Outcomes Scales collected at intake and discharge 5. Brief Symptom Checklist (BSCL) collected at intake and discharge
Key secondary outcome measure(s)	1. Perception of Care (PoC – Inpatient Questionnaire) collected at discharge 2. Satisfaction of patients’ relatives (Perceptions of Care-18 questionnaire) collected at discharge 3. Serious incidents involving deliberate self-harm and violence towards others. Routinely collected, will be measured every six months during a two-year follow-up period 4. Satisfaction of the resolution team (institutional questionnaire and focus group) questionnaire collected in summer 2018, focus group after the end of qualitative study
Completion date	10/05/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	142
Total final enrolment	237
Key inclusion criteria	1. Patients aged 18 to 65 2. Living in two districts of Southern Switzerland (“Bellinzona e Valli” versus “Lugano”) 3. Diagnosis of acute mental illness requiring hospital admission to the CPC from January 2017 4. Eligible for home treatment input according to a given operational definition of crisis
Key exclusion criteria	1. Highly suicidal patients 2. Patients with alcohol or drug problems [F10–F19] 3. Compulsory admission of a patient
Date of first enrolment	01/01/2017
Date of final enrolment	31/05/2019

Locations

Countries of recruitment

Switzerland

Study participating centre

Clinica Psichiatrica Cantonale

Via Agostino Maspoli 6
6850 Mendrisio
6850
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/06/2022	20/06/2022	Yes	No
Protocol article		09/11/2021	10/11/2021	Yes	No
Participant information sheet	version v1	25/10/2018	02/12/2020	No	Yes
Participant information sheet	version v3.6	13/03/2017	02/12/2020	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Preprint results		19/11/2021	14/03/2022	No	No

Additional files

ISRCTN38472626_PIS_qualitative study_v1_25Oct2018.pdf: Uploaded 02/12/2020
ISRCTN38472626_PIS_home treatment_v3.6_13Mar2017.pdf: Uploaded 02/12/2020

Editorial Notes

20/06/2022: Publication reference added.
14/03/2022: Preprint added.
10/11/2021: Publication reference added.
02/12/2020: The participant information sheets have been uploaded as additional files.
17/11/2020: Trial’s existence confirmed by Ethica Committee of the Canton Ticino.