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

2. Agenda
Introduction
Background
Protocol
Study Requirements
Governance
Project supported by

3. 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)

4. 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

5. 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

6. 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

7. 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)

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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)

15. Study Documents All study documents can be found on the study website:-
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

16. 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
Sponsor R&D
Nana Theodorou
Research Manager
Louese Dunn
SHAREHD Programme Manager
Sonia Lee
IRAS ID:
REC ID: 18/YH/0137
CPMS ID:

17. 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

18. 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

19. 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

20. Thank you! Any Questions?