Covid-19NCT04753242
Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals
An observational study of Covid-19 and COVID-19 Related Psychosocial Burden, run by University Hospital, Basel, Switzerland at 22 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, COVID-19 Related Psychosocial Burden
- What is being tested?
- Online survey questionnaire
- How many people
- 230 participants
- Where
- 22 sitesin 16 countries
- Study dates
- 8 Dec 2020to 3 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The heads of all psychosomatic, psychiatric and psychological C\&L services in acute care hospitals across all participating countries will be contacted and asked to participate. Contact will be made via the respective national professional societies and relevant working and interest groups
Who may be able to join
- heads of all psychosomatic, psychiatric and psychological C\&L services in acute care hospitals across all participating countries
Who cannot join
- None
Trial locations and contacts
22 sites in 16 countries.
22 sites in 16 countries
Canada2 sites
University of Montreal, Department of Psychosomatic Medicine
Montreal
TorontoSinai Health, University of Toronto, Department of Psychiatry
Toronto
Germany2 sites
University Hospital Cologne, Department of Psychosomatics and Psychotherapy
Cologne, North Rhine-Westphalia, 50937
Nuremberg Hospital, Department of Psychosomatic Medicine and Psychotherapy
Nuremberg, Bavaria, 90419
Italy2 sites
Bologna University
Bologna, 40123
University of Modena & Reggio Emilia
Modena, 411274
Portugal2 sites
Hospital de Santa Maria
Lisbon
Universidade Católica Portuguesa Lisboa
Lisbon
Switzerland2 sites
University Hospital Basel, Department of Psychosomatic Medicine
Basel, Canton of Basel-City, 4031
University of Basel, Department of Psychiatry (UPK)
Basel, 4002
United Kingdom2 sites
University of Exeter
Exeter
University of York
York
Austria1 site
Medical University of Graz, University Hospital Graz
Graz, Styria, 8036
About this study
Official title: Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals - an International Online Survey of Psychosomatic, Psychiatric and Psychological Consultation and Liaison (C&L) Services
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.
Read the detailed 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
- To summarize the efforts made in psychosocial care in the context of the COVID-19 pandemic.
- To assess the experiences made with the established services so far.
- To assess the need for networking, cooperation and support.
- 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.
- Conditions
- Covid-19, COVID-19 Related Psychosocial Burden
- Being tested
- Online survey questionnaire
- Keywords
- COVID-19 related psychosocial burden in patients, relatives and staff
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online survey questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start8 Dec 2020
- Primary completion3 Oct 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Schaefert, Prof. Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753242
- Sponsor's protocol ID
- Req-2020-00861; th21Schaefert
- Status last verified
- Oct 2021
- First submitted
- 11 Feb 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Feltz-Cornelis CM, Sweetman J, Lee W, Doherty AM, Dineen P, Meinlschmidt G, Vitinius F, Fazekas C, Huber CG, Schaefert R, Stein B. Determinants of workload-related clinician stress levels in general hospital consultation liaison psychiatry services during the COVID-19 pandemic in England and Ireland. Short report. J Psychosom Res. 2024 Feb;177:111584. doi: 10.1016/j.jpsychores.2023.111584. Epub 2023 Dec 30.
PubMed 38181547Schaefert R, Stein B, Meinlschmidt G, Roemmel N, Huber CG, Hepp U, Saillant S, Fazekas C, Vitinius F. COVID-19-Related Psychosocial Care in General Hospitals: Results of an Online Survey of Psychosomatic, Psychiatric, and Psychological Consultation and Liaison Services in Germany, Austria, and Switzerland. Front Psychiatry. 2022 Jun 24;13:870984. doi: 10.3389/fpsyt.2022.870984. eCollection 2022.
PubMed 35815043
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals - an International Online Survey of Psychosomatic, Psychiatric and Psychological Consultation and Liaison (C&L) Services
- ClinicalTrials.gov ID
- NCT04753242
- Acronym / sponsor ID
- Req-2020-00861; th21Schaefert
- Conditions
- Covid-19, COVID-19 Related Psychosocial Burden
- Keywords
- COVID-19 related psychosocial burden in patients, relatives and staff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 15 Feb 2021 (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.
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.
Detailed 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
- To summarize the efforts made in psychosocial care in the context of the COVID-19 pandemic.
- To assess the experiences made with the established services so far.
- To assess the need for networking, cooperation and support.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The heads of all psychosomatic, psychiatric and psychological C\&L services in acute care hospitals across all participating countries will be contacted and asked to participate. Contact will be made via the respective national professional societies and relevant working and interest groups
Key inclusion criteria (1 listed)
- heads of all psychosomatic, psychiatric and psychological C\&L services in acute care hospitals across all participating countries
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Online survey questionnaireSelf-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. | Other | – |
Primary outcome
Structural and process quality of COVID-19 related psychosocial C&L services
Time frame: 6 months
Data basis for improving quality of COVID-19 related psychosocial C\&L services: 1. characterization of participating C\&L services 2. involvement of respective hospitals in the physical care of COVID-19 patients 3. structures/ organization of psychosocial care for COVID-19 patients in participating hospitals 4. specific psychosocial support established in participating hospitals in context of COVID-19 for 1. patients 2. relatives 3. staff 5. communication strategies - How the different target groups were informed about COVID-19 related psychosocial support services and offers 6. burden of COVID-19 pandemic on psychosocial C\&L teams 7. needs and wishes of the participating psychosocial C\&L services 1. for support or exchange of experience regarding psychosocial care in the COVID 19 context 2. for changes / improvements considered essential for the future with regard to psychosocial care services in the participating hospitals in the COVID-19 context
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 38181547van der Feltz-Cornelis CM, Sweetman J, Lee W, Doherty AM, Dineen P, Meinlschmidt G, Vitinius F, Fazekas C, Huber CG, Schaefert R, Stein B. Determinants of workload-related clinician stress levels in general hospital consultation liaison psychiatry services during the COVID-19 pandemic in England and Ireland. Short report. J Psychosom Res. 2024 Feb;177:111584. doi: 10.1016/j.jpsychores.2023.111584. Epub 2023 Dec 30.
- Derived from this study: PubMed 35815043Schaefert R, Stein B, Meinlschmidt G, Roemmel N, Huber CG, Hepp U, Saillant S, Fazekas C, Vitinius F. COVID-19-Related Psychosocial Care in General Hospitals: Results of an Online Survey of Psychosomatic, Psychiatric, and Psychological Consultation and Liaison Services in Germany, Austria, and Switzerland. Front Psychiatry. 2022 Jun 24;13:870984. doi: 10.3389/fpsyt.2022.870984. eCollection 2022.
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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. This study is not recruiting at the moment.
Rainer Schaefert, Prof. Dr. med. principal investigator
University Hospital, Basel, Switzerland
22 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and COVID-19 Related Psychosocial Burden, run by University Hospital, Basel, Switzerland at 22 sites in 16 countries.
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 1 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: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, Germany, Italy, Portugal, Switzerland and 11 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Structural and process quality of COVID-19 related psychosocial C&L services (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753242, which also lists 2 linked publications.
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 28 Oct 2021.