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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04753242
Other study ID # Req-2020-00861; th21Schaefert
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 8, 2020
Est. completion date October 3, 2021

Study information

Verified date October 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Heads of all psychosomatic, psychiatric and psychological consultation and liaison (C&L) services in acute care hospitals across all participating countries will be contacted and asked to participate in this international cross-sectional online survey. The survey consists of questions about care structures and their utilisation that psychosomatic, psychiatric and psychological C&L services have established in acute hospitals in the context of the COVID 19 pandemic.


Description:

Background: The COVID-19 pandemic raised new challenges in supporting patients, relatives and staff for psychosomatic, psychiatric and psychological C&L services in general hospitals worldwide. It is intended to build upon the experience gained so far in order to be well prepared for the future. Objectives: The aims of this international online survey are 1. To summarize the efforts made in psychosocial care in the context of the COVID-19 pandemic. 2. To assess the experiences made with the established services so far. 3. To assess the need for networking, cooperation and support. 4. Improvement of psychosocial care in acute hospitals in the context of pandemics. Study Design: This health services research project will be carried out as an observational study in the form of an international cross-sectional online survey. There will be one survey time point. Study reporting will follow the STROBE Statement (Strengthening the Reporting of Observational Studies in Epidemiology). Ethic approval: In all participating countries the respective ethics committees were informed about the survey and it was checked with them, how far and what kind of country-specific vote of an ethics committee was necessary. Written statements, declarations or votes were obtained from all participating countries. Setting: The heads of all psychosomatic, psychiatric and psychological C&L services in acute care hospitals across all participating countries are contacted and asked to participate. Contact is made via the respective national professional societies and relevant working and interest groups. Participants This study is an international online survey with psychosomatic, psychiatric and psychological C&L services from 14 European countries (Austria, Belgium, Finland, Germany, France, Greece, Ireland, Italy, Norway, Poland, Portugal, Spain, Switzerland, United Kingdom) as well as parts of Canada (Quebec and Ontario region) and Iran participating. Country specific regions: The national coordinators of the participating country provided lists of specific regions for their respective country following the NUTS logic (Nomenclature of Territorial Units for Statistics; https://en.wikipedia.org/wiki/Nomenclature_of_Territorial_Units_for_Statistics), preferably a NUTS level that leads to 5 - 20 NUTS for each country. Online survey questionnaire: Self-developed questionnaire based on relevant literature, own experience and consultation with participating professional societies. The survey contains 25 questions on structural and process variables regarding characterization of the participating C&L services, involvement of the respective hospitals in the physical care of COVID-19 patients, structures / organization of psychosocial care for COVID-19 patients in the participating hospitals, specific psychosocial support for patients, relatives and staff established in the participating hospital in the context of COVID-19, communication - How the different target groups were informed about the COVID-19 related psychosocial support services and offers, burden of the COVID-19 pandemic on the psychosocial C&L teams, needs and wishes for the future. The study questionnaire was translated by a professional company from German into English, French and Italian. Language harmonization and cultural adaptation followed a modified committee-based approach informed by the European Social Survey (ESS) Round 9 Translation Guidelines. Participants are free to choose the language version to be worked on.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date October 3, 2021
Est. primary completion date October 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - heads of all psychosomatic, psychiatric and psychological C&L services in acute care hospitals across all participating countries Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online survey questionnaire
Self-developed questionnaire based on relevant literature, own experience and consultation with participating professional societies. The survey contains 25 questions on structural and process variables regarding psychosocial care structures that psychosocial C&L services have established in acute hospitals in the context of the COVID-19 pandemic, the implementation and use of COVID-19-related services for patients, relatives and staff, special challenges, as well as needs and wishes for the future. Thereby the survey is aiming at the creation of a data basis for improving the structural and process quality of psychosocial care services through psychosocial C&L services in the context of pandemics, especially the COVID-19 pandemic.

Locations

Country Name City State
Austria Medical University of Graz, University Hospital Graz Graz Steiermark
Belgium Ghent University Hospital, Department of Psychiatry Ghent
Canada University of Montreal, Department of Psychosomatic Medicine Montreal
Canada TorontoSinai Health, University of Toronto, Department of Psychiatry Toronto
Finland Oulu University Hospital and University of Oulu Oulu
France Université de Paris, Service de Psychiatrie de l'adulte Paris
Germany University Hospital Cologne, Department of Psychosomatics and Psychotherapy Köln Nordrhein-Westfalen
Germany Nuremberg Hospital, Department of Psychosomatic Medicine and Psychotherapy Nürnberg Bayern
Greece Aristotle University Thessaloniki Thessaloniki
Iran, Islamic Republic of University of Medical Sciences, Department of Psychiatry Tehran
Ireland University College Dublin Dublin
Italy Bologna University Bologna
Italy University of Modena & Reggio Emilia Modena
Norway Oslo University Hospital Oslo
Poland Wroclaw Medical University Wroclaw
Portugal Hospital de Santa Maria Lisboa
Portugal Universidade Católica Portuguesa Lisboa Lisboa
Spain Barcelona University Barcelona
Switzerland University Hospital Basel, Department of Psychosomatic Medicine Basel Basel-City
Switzerland University of Basel, Department of Psychiatry (UPK) Basel
United Kingdom University of Exeter Exeter
United Kingdom University of York York

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Finland,  France,  Germany,  Greece,  Iran, Islamic Republic of,  Ireland,  Italy,  Norway,  Poland,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structural and process quality of COVID-19 related psychosocial C&L services Data basis for improving quality of COVID-19 related psychosocial C&L services:
characterization of participating C&L services
involvement of respective hospitals in the physical care of COVID-19 patients
structures/ organization of psychosocial care for COVID-19 patients in participating hospitals
specific psychosocial support established in participating hospitals in context of COVID-19 for
patients
relatives
staff
communication strategies - How the different target groups were informed about COVID-19 related psychosocial support services and offers
burden of COVID-19 pandemic on psychosocial C&L teams
needs and wishes of the participating psychosocial C&L services
for support or exchange of experience regarding psychosocial care in the COVID 19 context
for changes / improvements considered essential for the future with regard to psychosocial care services in the participating hospitals in the COVID-19 context
6 months
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