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

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 2004. 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.

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.

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.

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…

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) 11 - 196 7 - 216 7 - 189 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…

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.

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

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.

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

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 - http://www.biomedcentral.com/1471-2288/14/47 HRA (2016) UK Policy Framework for Health and Social Care Research – Summary of consulation responses. http://www.hra.nhs.uk/documents/2016/06/uk-policy-framework-health-social-care-research-summary-consultation-responses.pdf