Preventative telehealth supported services for early stage chronic obstructive pulmonary disease: Lessons from a pilot randomised controlled trial Deborah A. Fitzsimmons 1 Claire Bentley 2, Gail A. Mountain 2 Jill Kenny 2, Kinga Lowrie 2, Stuart G Parker 2, Mark S Hawley 2 1 School of Health Studies, University of Western Ontario, London, ON, Canada 4 School of Health and Related Research, University of Sheffield, Sheffield, UK

Faculty/Presenter Disclosure Faculty: Deborah A. Fitzsimmons PhD Relationships with commercial interests: None This program has received financial support from: The National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care, South Yorkshire (CLAHRC SY) in the form of grant funding for the research team. This program has received in-kind support from: NHS Barnsley and Barnsley Metropolitan Council in the form of staff time and the procurement of the devices.

UK trial - Barnsley

Barnsley characteristics Aging Population – 2008 – 2031: Population increase by 16%  65 – increase by 67%  75 – increase by 80.5% History of coal mining history One of most deprived areas – Adverse lifestyle factors (diet, smoking) High incidence of COPD – 2.5% vs. UK avg. of 1.5%

The Technology

COPD RCT

Outcome measures Re-admitted to hospital with COPD Change in self-reported health status and quality of life at baseline, 8 weeks and eight months after start of service Requiring unscheduled healthcare support Cost effectiveness through quality adjusted life years (QALYs)

Innovative Partnership Barnsley Hospital Barnsley Primary Care Trust Barnsley Metropolitan Borough Council

Care Pathway Patient admitted to hospital with COPD Patient discharged from hospital Patient accepted on COPD service Patient discharged from service 8 week service Equipment removed Equipment installed Patient referred to COPD service HOSPITALPCTCOUNCIL Repairs / replacement Equipment maintained / cleaned

Standard Service Workload PATIENT CLINICAL INPUTADMIN INPUT Initial Assessment1 hour10 min phone triage 40 mins clinical admin 2 nd visit1 hour20 mins clinical admin 3rd visit1 hour20 mins clinical admin 4th visit30 min20 mins clinical admin 5 th visit30 mins20 mins clinical admin 6 th visit1 hour30 mins clinical admin 5 HOURS2 HOURS 40 MINS 10% tolerance for cancellations 45 MINS TOTAL WORKLOAD8 HOURS 25 MINS UNIT CAPACITY371 PATIENTS p.a.

Telehealth Service Workload PATIENT CLINICAL INPUTADMIN INPUT Initial Assessment1 hour10 min phone triage 40 mins clinical admin 2 nd visit30 mins20 mins clinical admin 20 mins clinical admin to check parameters 10 mins p/w (*8) to check patient status online 3 rd visit1 hour30 mins clinical admin 2.5 HOURS3 HOURS 20 MINS 10% tolerance for cancellations 35 MINS TOTAL WORKLOAD6 HOURS 25 MINS UNIT CAPACITY 487 PATIENTS p.a.31.2% increase

Patient Profile Age

What do users really think of tele-health monitoring? Quotes from interviews with users with COPD “It became a bit of a chore” “I’m lost without it” “I can stay at home and feel safe” “It didn’t do anything for me – it didn’t build my confidence or anything like that” “It’s like having someone to turn to” “I knew someone was watching and any indication that I was getting ill or anything, they’d get in touch” “I knew somebody was keeping an eye on me which was the main thing – there’s somebody there for you “I haven’t been back to hospital since that machine came in” “It’s one of the best things... I showed it to the chap who lives two doors away... They are going to put him on it” “The best service I’ve ever had” “It was quite simple to use...It’s not rocket science is it?” “The questions, they were a bit puzzling sometimes... The (answers) ought to be more in-between instead of black and white” Patient Views of Tele-hea lth

RCT Eligibility Criteria Male or female over age of 16 Discharged from hospital with COPD as primary or secondary diagnosis 1 – 3 hospital admissions in prior 12 months for COPD including this discharge – PCT definition of early stage COPD Willing to use telehealth Home landline in place Able to read English (technology requirement)

Reasons for exclusion from trial Other Reasons* (n=132)Number Backlog on telephone referral waiting list69 Not seen within adequate trial timeframe15 Readmitted to hospital straightaway11 Discharged over Christmas holiday period10 Disruptions to trial visiting schedule6 Unable to contact5 Patient does not believe they have COPD4 Other 12

EXPECTATIONREALITY Care pathways devised by the clinical team were in place No documented care pathways in place. Development of care pathways was difficult and time-consuming, delayed the research and contributed to later issues in the nursing team (Relatively) stable NHS environment with a team that had been in place for some years Continually shifting structures within the NHS and internal politics between teams (e.g. new COPD community nursing service perceived as threatening existing service) Issues Encountered

EXPECTATIONREALITY Technical procedures and necessary resources for the service were in place Resources/routines between the partners delivering the service to manage de/installation and cleaning of units took time to establish Readings can be automatically sent via telephone line to the secure server Technical issues prevented use of the device with certain landline companies

EXPECTATIONREALITY All patients discharged from hospital with COPD will be suitable for the technology Of 450 referrals, 180 (40%) of patients failed to meet the inclusion criteria for the study Most patients offered it will accept the technology The term ‘early stage COPD’ can be misleading and does not fully reflect the state of ill health experienced by this patient population. Many participants were simply too ill to take part at the time that they were provided with information about the services

EXPECTATIONREALITY Most homes are suitable for the installation of the technology Dispute over potential Health and Safety issues took time to resolve and a larger than expected number of patients did not have home landlines Systems for sharing data and identifying patients were in place Conflicts arose over how patient data should be shared between organizations Common language base Miscommunications occurred between different teams, possibly due to different vocabularies, priorities and team changes

EXPECTATIONREALITY Working with a small team would facilitate training and operationalizing the trial Staff illness and absence had a higher impact in terms of capacity and morale

Outcomes of the Pilot Planned to recruit 60 patients in 3 months (30 per arm) Recruited 63 (randomized 5 with no/unsuitable landline) so needed to recruit 65 patients in total but this took 12 months Lack of funding and support for full trial – Staff to be reassigned in organization shuffle – Testing alternate technology / approach introduced by new department management

References Telehealth RCT protocol: Fitzsimmons, D.A., Thompson, J., Hawley, M., Mountain, G.A.,

Thank you Any questions?