1. Ensuring Research quality in Care Home trials: Learning from NHS governance procedures
Amanda Lilley-Kelly
Senior Trial Co-ordinator
Leeds Clinical Trials Research Unit (CTRU)
Monday 8th May 2017

2. Developing Research Infrastructure
Care Home Research
ENRICH Network established 2012
ENRICH Toolkit – guidance for delivery of Care Home research
Research Ready Care Homes
NHS has established procedures to support research delivery, with the importance of research embedded in the NHS constitution.
Legislation that underpins was published in 2001, with resource pack for social care published in Iterations then published in 2005 and 2010.
NIHR clinical network established in 2006 and aimed to embed research providing staff to support research delivery within the NHS.
Dementia and Neurodegenerative network established ENRICH network in 2012.
ENRICH toolkit for guidance on delivery. Research Ready Care Homes…
HRA assumed responsibility for research in England in 2015 and are developing the UK Policy Framework for Health and Social Care.

3. Experience
DCM EPIC
Dementia Care Mapping™ (DCM™) to enable person-centred care for people with dementia and their carers: A cluster randomised controlled trial in care homes.
50 Care Homes across UK
Residents, Staff, and Relatives recruited
Researcher Follow-up at 6 and 16 months post CH randomisation
Aimed to recruit 50 care homes across the UK (3 hubs).
Cluster trial with Intervention delivered at CH Level.
Participants recruited (Resident, Staff, and Relatives)
Care Homes randomised
Follow-up assessments at 6 and 16M post randomisation completed by study researchers…
Funding acknowledgement This project was funded by the NIHR HTA (project number 11/15/13) Department of Health disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

4. Complexities Site Selection Ongoing Engagement Data Management
(Care Home Recruitment)
Access
Identification of homes
Staff Engagement
Approvals
Data Management
Management
Development of data collection instruments
Research Naïve Environment
Completion and storage of data
Training (DPA/GCP)
Transfer of data
Vulnerable population (Capacity)
Follow-up Assessments
Timelines
Intervention Delivery
Training
Staff Turnover
Adherence
Complexities within CH research evident within literature, associated with research naive environment…
Focus on complexities associated with research infrastructure – Site recruitment and Data Management.

5. Scope to maximise generalisability of outcomes
Site Selection
Scope to maximise generalisability of outcomes
Aimed to recruit a random sample of CHs and maximise generalisability of outcomes – mindful of ENRICH research ready care home network.
Summarise process followed…

6. Site Selection Development of Letters of Agreement (LoA)
Including supporting materials for “Invitation Mailing”
50 UK Care Homes over 1 year period
21 Yorkshire
15 Greater London
14 Oxfordshire
Average timeline for completion of approvals (LoA) : 72 days
Comparable to NHS permissions
Yorkshire
London
Oxfordshire
No. Invitation Mailings 7 8 5
Mailing Timeline
May 2014 – June 2015
May 2014 – July 2015
Nov 2014 – Aug 2015
Av. time to complete LoA (days) 75 57 82
Range (days)
Permissions process;
Developed LoA to identify key issues for project delivery, for example, Attendance at training, staff time (intervention/data collection), storage of data. Similar to NHS capacity and capability assessment.
Involvement acknowledged by CH manager and Owner/Org.
DCM EPIC aimed to recruit 50 care homes over approx. 1 year period, with X homes per hub
Average timeline for recruitment 72 days – comparable, if not better than NHS.
Summarise table for variation by region…

7. Site Selection Changes in Care Home Management
Ongoing permissions to access
Monitoring changes during study involvement
Monthly contact calls (safety)
DCM EPIC - Management Changes in 22/50 homes taking part
No homes withdrawn from overall participation
(50 homes over 3 year period)
Yorkshire
London
Oxfordshire
No. CHs 11 4 7
Range
1-3 1
1-2
Acknowledge importance of CH manager engagement for ongoing delivery of project
Highlight process for monitoring changes – difference in notification of a change of PI at site in NHS.
Summarise experience from EPIC.
Highlight 50 homes engaged over 3 year period.

8. Data Management
Consideration of Care Home environment in accordance with key Research principles…
Completion and Storage of data (GCP Principles)
Transfer of data – Class A Sensitive (Data Protection Act)
Considerations for CRF development
Completion of Follow-up visits
Resident Summary
Resident details (Full Name/DoB)
Death / Loss to follow-up
Ongoing consent (Capacity)
Optional Elements
Key to consider complexities of care home environment and appropriate procedures to support project delivery.
Busy env. with limited facilities to store data – far from researcher base.
Development of data collection instruments to support completion, storage, and transfer of data in accordance with GCP principles and the DPA.
Associated consideration of follow-up procedures, with minimal info in the home.
Development of FU Listing…
Importance of identifiers to support research delivery – minimal information stored in the home.
Confirm consent process
Engagement in research interviews

9. Key considerations Time Resource Experience (Researchers/CTU)
To develop appropriate trial procedures to support successful delivery.
To develop data management systems to support trial monitoring.
Resource
Ensure appropriate funding for resources to support CH environment.
Experience (Researchers/CTU)
Research principles required to support research delivery (i.e. Informed Consent - MCA, GCP, DPA).
Understanding of Care Home environment.

10. Acknowledgments University of Leeds Amanda Farrin Rebecca Walwyn
Suzanne Hartley
Liz Graham
Vicki McLellan
Professor Claire Surr (Chief Investigator) and the DCM EPIC Trial Team
Sponsor: Leeds Beckett University
Funding acknowledgement This project was funded by the NIHR HTA (project number 11/15/13)
Department of Health disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

11. Reference
Davies et al (2014) Enabling research in care homes: an evaluation of a national network of research ready care homes. BMC Medical Research Methodology -
HRA (2016) UK Policy Framework for Health and Social Care Research – Summary of consulation responses.