Submission date
06/05/2021
Registration date
19/05/2021
Last edited
15/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Retrospectively registered
Protocol added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Background and study aims
Since nursing home residents are at substantial risk from COVID-19, nursing home care staff need to know what residents would want to happen should they become infected with COVID-19. The aim of this project is to develop and evaluate advance care planning COVID-centric online training and information resources for nursing home staff and family members to improve care at the end of life during a COVID-19 outbreak.

Who can participate?
Registered nurses and health care assistants working in nursing homes in the United Kingdom. Family members aged 18 years and older who are involved in the care of a resident in participating nursing homes.

What does the study involve?
This study involves the development and evaluation of an online COVID-centric advance care planning intervention. Findings from a rapid review of advance care planning resources will be used to develop the intervention for nursing homes. To evaluate the intervention, nursing home staff will be asked to participate in training and family members asked to review information via the online resource. Participants will be asked to take part in an interview prior to and 1-week following the implementation of the intervention.

What are the possible benefits and risks of participating?
Participating in this study may enhance knowledge and support advance care planning discussions in the context of COVID-19 with residents and their families. Participants may feel emotional. If this happens, participants can stop their involvement in the study at any point.

Where is the study run from?
Queens University Belfast (UK) is managing this study.

When is the study starting and how long is it expected to run for?
From June 2020 to August 2021.

Who is funding the study?
This project is co-funded by The Economic and Social Research Council (ESRC) as part of the UK Research and Innovation’s rapid response to COVID-19 and The Health and Social Care Research & Development Division (HSC R&D Division) of the Public Health Agency in Northern Ireland.

Who is the main contact?
Professor Kevin Brazil
k.brazil@qub.ac.uk

Study website

https://covidacpcarehomes.com/

Contact information

Type

Scientific

Contact name

Prof Kevin Brazil

ORCID ID

http://orcid.org/0000-0001-7669-4991

Contact details

Queens University Belfast
Medical Biology Centre
97 Lisburn Rd
Belfast
BT9 7BL
United Kingdom
+44 (0)28 9097 5782
k.brazil@qub.ac.uk

Type

Public

Contact name

Prof Kevin Brazil

ORCID ID

Contact details

Queens University
Belfast
Medical Biology Centre
97 Lisburn Rd
Belfast
BT9 7BL
United Kingdom
+44 (0)28 9097 5782
k.brazil@qub.ac.uk

Additional identifiers

EudraCT/CTIS number

Nil known

IRAS number

286725

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 286725

Study information

Scientific title

Necessary discussions: Advance care planning for nursing homes in a COVID-19 outbreak

Acronym

Study hypothesis

One way of ensuring that care reflects residents wishes and preferences is to develop an advance care plan. However, critical gaps have been highlighted in research, policy and practice around advance care planning tools, training, and information resources.

The aim of this project is to develop and evaluate an online advance care planning COVID-centric resource for nursing homes during a COVID-19 outbreak to improve care at the end of life.

Ethics approval(s)

Approved 08/12/2020, Health and Social Care Research Ethics Committee B (HSC REC B, ORECNI office, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, BT28 2RF; +44 (0)28 95361400; RECB@hscni.net), ref: 20/NI/0173

Study design

Multicenter prospective case study design

Primary study design

Interventional

Secondary study design

Non randomised study

Study setting(s)

Internet/virtual

Study type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Care at the end of life during a COVID-19 outbreak

Intervention

An online educational intervention for nursing home staff and family members on advance care planning during a COVID-19 outbreak will be developed. An expert reference group will advise on all aspects of the project and findings from a rapid review of advance care planning resources will be used to develop the intervention.

The intervention will be implemented in three locations across the UK (N. Ireland; England & Scotland). Up to three nursing homes in each location will be recruited. Up to five staff members in each nursing home will complete online training on advance care planning during a COVID-19 outbreak. The training will include the following six units:
1. An introduction to advance care planning in the context of a COVID-19 outbreak
2. Advance care planning in the context of a COVID-19 outbreak
3. How to complete an Advance Care Plan during a COVID-19 outbreak
4 Recording and sharing Advance Care Plans during a COVID-19 outbreak
5. Finding the words: Tips for having necessary discussions
6. Caring for yourself during a COVID-19 outbreak

Family members will review online information on advance care planning during a COVID-19 outbreak, including
1. What is advance care planning?
2. Why is advance care planning important?
3. What might be included in an advance care plan?
4. Who takes part in advance care planning
5. How do I take part in an advance care pla
6. Caring for myself during COVID-19.

Environmental scan interviews will be conducted before the intervention is implemented to identify characteristics and potential barriers and facilitators to implementation. Follow-up interviews will be carried out 1-week post intervention to explore the acceptability of the intervention and its impact.

Intervention type

Behavioural

Primary outcome measure

Acceptability of advance care planning COVID-centric online training resources and information for nursing home staff and family members measured using interviews carried out 1-week post-intervention

Secondary outcome measures

1. Barriers and facilitators to implementing an online educational intervention on advance care planning during a COVID-19 outbreak will be measured during pre-intervention interviews
2. The proportion and representativeness of identified nursing home staff and family members who access the online information and the features viewed will be measured using google analytics
3. Impact on knowledge and attitudes towards advance care planning will be explored using feedback forms and post-intervention interviews
4. Intention to participate in advance care planning conversations during a COVID-19 outbreak will be measured during post intervention interviews

Overall study start date

08/06/2020

Overall study end date

31/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Nursing home staff: Registered nurse or health care assistant.
2. Family members: Aged 18 years or older; Be the individual most involved in the care of the resident; Have access to digital resources.

Participant type(s)

Mixed

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

Up to 45 nursing home staff and up to 54 family members

Total final enrolment

54

Participant exclusion criteria

1. Under 18 years of age
2. Do not have access to digital resources

Recruitment start date

18/02/2021

Recruitment end date

14/06/2021

Locations

Countries of recruitment

Northern Ireland, United Kingdom

Study participating centre

Queens University Belfast
University Road
Belfast
BT7 1NN
United Kingdom

Sponsor information

Organisation

Queen's University Belfast

Sponsor details

University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
+44 (0)28 9024 5133
researchgovernance@qub.ac.uk

Sponsor type

University/education

Website

http://www.qub.ac.uk/

ROR

https://ror.org/00hswnk62

Funders

Funder type

Research council

Funder name

The Economic and Social Research Council as part of the UK Research and Innovation's rapid response to COVID-19

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Health and Social Care Research & Development Division (HSC R&D Division) of the Public Health Agency in Northern Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

Public Health Agency

Alternative name(s)

PHA

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

Intention to publish date

31/08/2022

Individual participant data (IPD) sharing plan

The current data sharing plans for this study are unknown and will be available at a later date

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 09/08/2022 15/08/2022 Yes No
Results article 13/05/2022 15/08/2022 Yes No
HRA research summary 28/06/2023 No No

Additional files

Editorial Notes

15/08/2022: Publication references added. 08/10/2021: The total final enrolment number has been added. 18/05/2021: Trial's existence confirmed by Economic and Social Research Council.