Condition category
Nervous System Diseases
Date applied
12/12/2011
Date assigned
02/03/2012
Last edited
13/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Department of Health is promoting the implementation of systems that encourage high-quality end of life care across hospital, community and care homes. One of these tools is called the Gold Standards Framework for Care Homes (GSFCH). This is an 18-month programme that helps care homes to implement a framework to improve the end of life care of residents and families. St Christopher's Hospice, London is currently a regional training centre for the GSFCH programme. This programme involves two care home senior nurses attending four study days at St Christopher's Hospice. They then return to their care home to share what they have learnt in order to change practice. To do this they need to implement a number of tools e.g. undertaking an advance care plan, assessment of symptoms and prognosis, and documentation to record care during the last days of life. The GSFCH national team recommend that facilitation is provided to care homes introducing the framework. However, there is minimal information guiding the level of facilitation required. It is currently unknown what level of facilitation is necessary to implement the framework into practice and to achieve the outcomes originally intended by the GSFCH national team. Previous work introducing the GSFCH framework has highlighted the importance of facilitation when introducing the programme. St Christopher's now use a model of 'high facilitation'. However, there has been no study to look at the cost/benefit of such a facilitation model. The high facilitation model provided by St Christopher's means that a nurse facilitator visits a nursing care homes (NCH) two to three times a month to role model and empower staff in the use of the tools recommended by the GSFCH framework. The aim of this study is to determine the cost-benefit of providing 'high facilitation' when implementing the GSFCH. The objectives are: to evaluate the implementation of the GSFCH programme in 30- 45 NCHs; to measure outcomes arising from when implementing the GSFCH programme; and to explore the cost-benefit of providing different levels of facilitation.

Who can participate?
Participants include managers and staff from NCHs who applied to take part in the Phase 6 GSFCH regional training programme at St Christopher's Hospice. Each of the NCHs were registered to care for frail older people. Also included are the bereaved relatives of deceased residents.

What does the study involve?
Twenty four NCHs within the St Christopher's catchment area and fourteen outside the area are taking part in the study. Those NCHs within the St Christopher's catchment area were randomly allocated into two different intervention groups. Both of these groups received high facilitation but in addition the managers of one group participated in monthly action learning. The NCHs outside the catchment area formed a third observational group which received the normal facilitation as provided by the GSFCH central team.

What are the possible benefits and risks of participating?
The NCH managers who applied to take part in the programme knew what they were enrolling for. There are no risks to the NCH managers; instead, there is a benefit for those NCHs being supported through high facilitation of the GSFCH programme provided by St Christopher's Hospice. However, there could be a risk to those NCH managers outside the catchment area who are only receiving the normal facilitation. They may feel envious of a higher quality of input of facilitation to the NCHs within St Christopher's catchment area. A second risk across all NCHs is that of inviting bereaved relatives to complete a questionnaire of the residents/family experience of end of life care received in the NCH. This was minimised by the information sheet containing a contact number of an experienced palliative care nurse for extra information about the study. The information sheet also had an additional contact number to access bereavement support.

When is the study starting and how long is it expected to run for?
The study started in October 2009 and is due to complete in March 2012.

Who is funding the study?
St Christopher's Hospice and a local charity fund the trial.

Who is the main contact?
Dr Josephine Hockley
j.hockley@stchristophers.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Josephine Hockley

ORCID ID

Contact details

Care Home Project Team
St Christopher's Hospice
Lawrie Park Road
London
SE26 6DZ
United Kingdom
+44 (0)20 8768 4727
j.hockley@stchristophers.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of different models of facilitation when implementing the Gold Standards Framework in Care Homes (GSFCH): a cluster randomised control trial

Acronym

Study hypothesis

'High facilitation' when implementing the Gold Standards Framework in Care Homes (GSFCH) will result in a reduced number of hospital deaths for residents and improvement in the care home staff ability to facilitate good end of life care.

Ethics approval

Joint UCL/UCLH Ethics Committees of Human Research, 08/10/2009, ref: 09/H0715/74

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Unspecified dementia

Intervention

The study will take place in up to 45 NCHs taking part in Phase 6 Gold Standards Framework in Care Homes [GSFCH] programme at St Christopher's Hospice. Three cohorts of nursing care homes [NCHs] will be established with up to 15 NCHs in each cohort. There will be two intervention cohorts and one observational cohort:

Cohort 1: Intervention Arm - high facilitation of GSFCH programme + 'action learning' with each nursing home manager
Cohort 2: Intervention Arm - high facilitation of GSFCH programme
Cohort 3: Observational arm)

High facilitation will consist of the appointment of two coordinators from each NCH (depending on the number of beds - a large NCH will require additional coordinators) and an appointed facilitator. It will also consist of:

1. Preliminary Phase - Macmillan 'Foundations in Palliative Care for Care Homes' training for all key coordinators
2. First year - Facilitator to visit NCH 2-3 times a month (+/- one contact). All NCHs will implement the LCP or minimum protocol
3. Second year- Facilitator support in the development of local NCH network forums which will provide:
3.1 Induction Days for new staff every 6 months
3.2. 'Foundations in Palliative Care for Care Homes' training - 4 modules/year
3.3. Further role modelling for complex situations by CNS/GSFCH facilitator

'Action learning' will be offered to Cohort 1 alongside the above high facilitation. Each nurse manager will be asked to attend one 3-hour action learning set every month for nine months. The action learning sets will be facilitated and evaluated.

Electronic cluster randomisation will be undertaken by an outside agency in order to form the two intervention cohorts from the intervention arm. NCHs will be stratified according to their geographical location in order to account for variety in end of life care provision.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reduced number of hospital deaths which will be analysed through the retrospective review of deceased residents records. This review is being undertaken over a 3-year period - one year retrostpective to the intervention and then two years during/following.

Secondary outcome measures

1. To understand the cost/benefit implications of providing the intervention
2. To examine the provision of end of life care before and after the intervention
3. To determine the sustainability of the programme through the intervention
4. The following measures to collect data are being used:
4.1. Nurse manager's questionnaire (pre/post)
4.2. 'Competency document' to all nurses in NCHs (pre/post)
4.3. 'Teamwork questionnaire' to all staff in NCHs (pre/post)
4.4. 'Palliative care quiz' questionnaire for nurse coordinators (pre)
4.5. VOICES questionnaire to relatives of residents who have died (pre/post)
4.6. The 'Family Perception of Care' questionnaire to relatives of residents who have died (during)
4.7. Action Learning for nurse managers in Cohort 1 (during)

Overall trial start date

10/10/2009

Overall trial end date

10/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. All willing nursing care homes (NCHs), and where present their GSFCH facilitators, that care for frail older people with or without dementia who have completed an application form to take part in Phase 6 GSFCH programme at St Christopher's Hospice.
2. Participants were adults of various age ranges and genders

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

NCHs = 38, Deceased residents notes from 01/06/2008 to 31/05/2011 = approximately 2,311

Participant exclusion criteria

1. NCHs in the 'intervention' arm whose managers are not willing to participate in 'action learning'
2. NCHs outside the immediate St Christopher's area but whose facilitator has close contact with the project team
3. NCHs outside the private sector
4. NCHs that care for young chronic sick/disabled residents

Recruitment start date

10/10/2009

Recruitment end date

10/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Christopher's Hospice
London
SE26 6DZ
United Kingdom

Sponsor information

Organisation

St Christopher's Hospice (UK)

Sponsor details

c/o Mr Nigel Sykes
Medical Director & Medical Consultant
Lawrie Park Road
London
SE26 6DZ
United Kingdom
+44 (0)20 8778 9252
n.sykes@stchristophers.org.uk

Sponsor type

Hospital/treatment centre

Website

http://www.stchristophers.org.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

St Christopher's Hospice (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24942282

Publication citations

Additional files

Editorial Notes