DIALYSE @ HOME Dialyse@Home: A Mixed Methods Pilot Study of Home Haemodialysis Site Initiation Visit Programme Supported By

Agenda Introduction Background Protocol Study Requirements Governance Project supported by

Introduction One of the outcomes from the SHAREHD collaborative is that people often choose to go home and dialyse This pilot study is aiming to explore the impact of HHD on patient and carer experience community integration and cost effectiveness with the objective of obtaining primary evidence to develop theories, identify mechanisms and quantify benefits that will support increased uptake across the UK The study is funded by the Health Foundation and Sheffield Hospitals Charity REC & HRA approvals have been obtained The study is on the NIHR Research Portfolio (Ref: 35943)

Overarching Aims of this Pilot   To work collaboratively with patients and their co-habitants To test the best ways to explore the experience of and outcomes that matter to home haemodialysis (HHD) patients by piloting processes of information collection and identifying the instruments that are best suited to this patient group and these circumstances Undertake patient and carer interviews to map the individual journey to HHD, understand achievement of competencies, barriers, facilitators and support mechanisms and to better understand carer burden Evaluate the use of Social Return on Investment methodologies to measure broader socio-economic outcomes, permitting the inclusion of the views of multiple stakeholders in a singular monetary ratio The ultimate goal will be to use this pilot information to prepare a research grant that will allow us to develop an intervention (s) that enables better support for HHD from the patient perspective and therefore makes HHD a much more attractive option to patients

Proposed Full Study Objectives  To better understand - the patient and carer (cohabitee) experience of home haemodialysis and wider support needs community links (assets) and how these can be utilised to reduce social isolation educational experience that HHD patients receive to prepare them for the modality choice and uptake of the therapy health economics of HHD including the monetary and non-monetary costs using SROI methodologies the technological challenges of HHD with a view to identifying practical solutions

Patient and Caregiver Perspectives on Home Haemodialysis : A Systematic Review Conclusions: Patients and Caregivers perceive that home HD offers the opportunity to thrive, improves freedom, flexibility and well being ; and strengthens relationships. However , some voice anxiety and fear about starting home HD due to the confronting nature of the treatment and isolation form medical and social support. Acknowledging and addressing these apprehensions can improve the delivery of pre-dialysis and home HD programmes to better support patient and caregivers considering home HD. Study Context

The Dialyse@Home Team The Team is made up of: 7 Trusts (4 definite, 3 potential) Patient Partner (Andy Henwood) Chief Investigator/Clinical Lead (Martin Wilkie) Research Lead (Louese Dunn) Evaluation Lead (Steve Ariss – CLAHRC)

Study Timeline Date Event 6th September 2018 SIV Held 31st October 2018 Recruitment Period Ends 30th April 2019 Follow-up Period Ends 31st July 2019 Data Analysis Complete

Protocol Walkthrough 20 Home Haemodialysis patients, and 20 carers will be recruited (~5 patients and 5 carers per site) Baseline & follow-up Questionnaires (see later slide) 10 patients and 10 carers will be asked to take part in one semi structured interview (~2 patients and 2 carer per site) Evaluation Partners are The CLAHRC Yorkshire and Humber

Patient Recruitment Inclusion Criteria Established on home haemodialysis Capacity to give written informed consent to participate in the study Able to speak and read English Exclusion Criteria Patients who are too unwell to engage in the study (as judged by the clinical team) Patients too distressed to participate (as judged by the clinical team) Patients with impaired capacity who are unable to give informed consent Patients unable to understand written and verbal communication in English

Patient Recruitment All suitable prevalent dialysis patients will be entered into a screening log (template will be provided). From this log patients will be approached and given the opportunity to participate in the research project. Informed consent will be taken by trained delegated members of the local research team who have appropriate GCP training Participants will be given the study information sheet and will be given the opportunity to ask questions and give informed consent Participants will be given a unique study ID Code: UNIT NUMBER – INITIALS – P01 OR C01, then sequential Sheffield are unit 01

Site ID Sheffield 01 York 02 Nottingham 03 Derby 04 Stoke 05 Sunderland 06 Devon 07 Patient Sequential Patient Number Linked Carer Number Patient Louese P01 C01 Patient Sonia P02 - Patient Martin C03 Patient Steve P04 C04 Patient Megan P05 Patient Bernie Patient James P06 C06

Ongoing throughout the study period Schedule of Events Activity Baseline Month 6 Participant Consent (Carer and Patient) X Participant - Patient Questionnaire Participant – Carer Questionnaire Participant Interview Ongoing throughout the study period

Study Instruments Domain Instrument Patient Carer Patient details Demographic form X Vascular access Short-form Vascular Access Questionnaire(SF-VAQ) Symptom burden Renal Symptom Score (iPOS-S) (Inc in YOUR HEALTH SURVEY) Managing your health Patient Activation Measure (Inc in YOUR HEALTH SURVEY) Carer burden Cousineau Scale of perceived burden Adult Carer Quality of Life Questionnaire - Overall health EQ-5D-5L (Inc in YOUR HEALTH SURVEY) Treatment satisfaction Renal treatment satisfaction questionnaire (RTSQ) Illness intrusiveness Illness intrusive Ratings Scale (IIRS)

Study Documents All study documents can be found on the study website: www.shareddialysis-care.org.uk - Participant questionnaires should be returned to Louese Dunn in Sheffield for data inputting (Louese will contact you to arrange this) Completed questionnaires should be batched and couriered after each data collection point Return Address Sheffield Kidney Institute, Sorby Block Northern General Hospital Herries Road Sheffield S5 7AU

Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Study Management Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Title Name Contact Details Chief Investigator Prof Martin Wilkie Martin.wilkie@sth.nhs.uk 0114 271 5148 Sponsor R&D Nana Theodorou Nana.theodorou@sth.nhs.uk 0114 271 2763 Dialyse@Home Research Manager Louese Dunn Louese.dunn@sth.nhs.uk 0114 271 5199 SHAREHD Programme Manager Sonia Lee Sonia.lee@sth.nhs.uk 0114 271 5896 IRAS ID: 244231 REC ID: 18/YH/0137 CPMS ID: 35943

Investigator Responsibilities for the Site File The ISF should be retained at site securely The ISF should contain all essential documents from beginning to end of the study and provide a retrievable audit trail Maintain a site delegation log of all staff performing study procedures and CVs, as per local trust policy The ISF need to be archived at the end of the study for no less than 5 years

Source Data and Archiving Confirm that informed consent, date and participant’s study ID are documented in their medical records with a copy of the participant information sheet and consent form Document the date and time of each study visit in the medical records Follow local policy for ensuring medical records are retained for no less than 5 years

Regional innovation fund KEY PARTNERS Patients and carers Participating acute health care trusts Y & H Regional innovation fund If you have been supported locally Please provide us with YOUR log and we can add it to this wall of fame/ thanks

Thank you! Any Questions?