Condition category
Mental and Behavioural Disorders
Date applied
29/10/2020
Date assigned
17/11/2020
Last edited
17/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mr Rafael Traber

ORCID ID

Contact details

Via Luganetto 5
Viganello
6976
Switzerland
+41 7624050 67
rafael.traber@ti.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NRP74 407440_167375

Study information

Scientific title

Home treatment for acute mental healthcare in Ticino: protocol of the Foresight study

Acronym

Foresight

Study hypothesis

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

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

Study design

Interventional non randomised quasi-experimental study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (in Italian)

Condition

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

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

28/03/2017

Overall trial end date

10/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

142

Total final enrolment

237

Participant exclusion criteria

1. Highly suicidal patients
2. Patients with alcohol or drug problems [F10–F19]
3. Compulsory admission of a patient

Recruitment start date

01/01/2017

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Switzerland

Trial participating centre

Clinica Psichiatrica Cantonale
Via Agostino Maspoli 6
6850 Mendrisio
6850
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation

Sponsor details

Wildhainweg 3
Postfach
Bern
3001
Switzerland
+41 (0)313082222
desk@snf.ch

Sponsor type

Government

Website

http://www.snf.ch/en

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Switzerland

Results and Publications

Publication and dissemination plan

Four publications are planned in peer reviewed journals:
1) publication of the resrarch protocol
2) publication of the clinical results
3) publication of the cost-effectivness
4) publication of the qualtiative analysis

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/11/2020: Trial’s existence confirmed by Ethica Committee of the Canton Ticino.