Evaluation of a medical device pilot
Our Improvement Science theme was commissioned to evaluate regional piloting of a wireless handheld medical device – TytoCare - which enables patients/carers to perform a range of clinical-grade medical examinations from home. The pilot is led by the Yorkshire and Humber Academic Health Science Network and is linked to an initiative by the NHS England ‘Beneficial Changes Network’ which sought examples of innovations introduced due to Covid-19. TytoCare was introduced to reduce the need for face to face appointments for vulnerable patients, whilst still providing continuity of care.
TytoCare can be used to perform medical examinations for the ear, throat, lungs, heart, temperature, skin and abdomen. An example of the device as used by patients/carers is a parent of a child with long standing respiratory problems performing a breathing examination as per instructions generated by the device and submitting the data to their hospital consultant for review. The device can also be used by health care professionals: an example is a district nurse performing heart rate and temperature readings for a recently discharged patient in a care home, and then submitting the data for review by a hospital consultant. Thus, the device enables remote monitoring of patients as well as remote diagnosis of a range of acute conditions, including colds, flu, ear infections, and bronchitis. It gained Food and Drug Administration (FDA) approval in 2016 in the Unites States, and Conformitè Europëenne (CE) Mark Approval in Europe in 2019.
The YHAHSN led pilot involves 23 separate pilot projects spread across 14 sites in the Yorkshire and Humber region. The first of the projects launched in April 2021, with the remaining anticipated to be launched by the end of March 2022. The sites are a mix of NHS Teaching Hospitals, Foundation Trusts, Hospital Trusts, care homes and General Practice groups and cover paediatric care, urgent and emergency care, working age adults and older people. The improvement science theme is working collaboratively with the YHAHSN, the Improvement Academy, and the NIHR Children and Young People’s Med Tech team on this evaluation.
This is a mixed methods evaluation, using data downloaded from the TytoCare devices, qualitative interviews with health care professionals and other ‘key informants’ at a small sample of sites, and validated patient (the Servicer-User Technology Acceptance Questionnaire) and health professional feedback surveys (Weiner et al’s 2017 measures of acceptability and appropriateness).
The selection of outcomes, gathered from the routine data, surveys and qualitative interviews, was guided by Proctor et al’s implementation outcomes framework (2011) (Figure 1 below) and the consolidated framework for implementation research (Damscroder et al, 2009). The latter was included to assess factors that have facilitated or have been barriers to effective implementation.
A blog, discussing the challenge of evaluating a medical device at pace and across a broad range of sites and settings was published by the team in March 2022: it can be accessed here: Tackling evaluation of a digital device.
We are still collecting data and will update once the evaluation is complete.