Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05244941 |
| Other study ID # |
300719 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
University of Oxford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Aim; To inform high-quality, safe and equitable care in the United Kingdom (UK) general
practice (GP) in the context of policies which require phone, video or e-consultation by
default.
BACKGROUND When COVID struck, general practice shifted to predominantly phone, video or
e-consultations instead of face-to-face. Remote had benefits (e.g. reducing spread of COVID),
but also downsides (technical glitches; inequalities of access; missed diagnoses; reduced
continuity of care; and patients simply not seeking care at all). Despite this, the Secretary
of State for Health of the UK, Matt Hancock declared on 30th July 2020 that remote-by-default
is here to stay.
RESEARCH QUESTION To what extent is remote-by-default, introduced for infection control
during the pandemic, fit for purpose for the long term - and how can we make remote care
better and safer?
DESIGN AND METHODS Mixed-method case study with co-design workshops and cross-sector
stakeholder events.
OBJECTIVES AND METHODS
1. GP PRACTICES The investigators will support 10 GP practices to develop effective remote
services and alternatives where needed. The investigators will help them collect data
and use their findings to inform improvement efforts.
2. PATIENTS The investigators will interview 40 patients selected for diversity (age,
ethnicity, locality, socio-economic status, condition[s], digital literacy), and hold
two workshops (one remotely and one in person, Covid allowing) where patients help
co-design ways to combine remote and face-to-face models.
3. WIDER SYSTEM The investigators will engage stakeholders - including policymakers,
professional bodies, industry, civil society and patient groups - in ongoing dialogue
about how to deliver and support a more equitable, less risky remote-by-default service.
The investigators will interview patients and hold cross-sector stakeholder events (big
Zoom meetings), working both before and after the events to build relationships and
action ideas.
Description:
AIM: To inform a more fit-for-purpose remote-by-default model in UK general practice which
takes account of a) quality and safety of care, b) equity and inclusivity, c) staff wellbeing
and training, and d) the wider technical and regulatory infrastructure.
STRATEGIC OBJECTIVES
1. PRACTICE LEVEL: Follow a sample of 10 GP practices for two years as they seek to
introduce, improve and sustain remote-by-default consultations, supporting practices in
developing effective remote services and equitable alternatives to remote where needed.
2. PATIENT LEVEL: Capture the patient experience of remote-by-default consultations and
ensure that this perspective is incorporated in practice- and system-level efforts to
improve and augment remote-by-default services.
3. SYSTEM LEVEL: Engage a wide range of stakeholders - including policymakers, the UKs
National Health Service (NHS), professional bodies, industry, civil society and patient
groups - in an ongoing dialogue about how to deliver and support a more equitable, less
risky remote-by-default service.
OPERATIONAL OBJECTIVES
1. PRACTICE LEVEL:
1. Using an embedded researcher-in-residence model, build relationships with 10 GP
practices selected for maximum variety in digital maturity, geographic location
(e.g. urban/rural/remote) and population demographics. Support patient and public
involvement (PPI) reps in those practices.
2. Undertake interviews (up to 10 per practice) and collect documentary data (e.g.
protocols, patient leaflets, workload data) from each practice to build a case
study.
3. Follow practice case studies longitudinally over time, supporting them to a)
optimise quality and safety of care; b) ensure digital inclusion and provide
equitable alternatives for the digitally excluded; c) maintain wellbeing and train
and support their staff; d) overcome infrastructural hurdles (both technical and
regulatory).
4. Run two online co-design workshops for up to 40 people each (with hands-on
activities in small groups), incorporating insights from patient/carer workshops
(see below).
2. PATIENT LEVEL:
1. Recruit a diverse sample of 40 service users (patients and carers), most of whom
will be registered with participating GP practices, with some identified through
patient groups or snowballing, ensuring that the investigators include a range of
people at risk of digital exclusion.
2. Through narrative interviews (by phone, video or face to face as preferred),
capture the patient/carer experience of remote-by-default consultations across four
key quality and safety areas (long term condition monitoring, getting an
appointment with own clinician, symptoms that could indicate early cancer, and
complex multi-morbidity).
3. Hold two co-design workshops (one remote and one face to face), each with up to 20
patients and carers, to generate insights about how digital inclusion impacts on
access and quality and safety of care, and generate a range of 'digital inclusion
personas'.
3. SYSTEM LEVEL:
1. Build relationships with key stakeholders (listed under strategic objective 3)
through up to 30 elite interviews and extending our ongoing stakeholder map.
2. Hold four large, cross-sector stakeholder events, including preparatory and
follow-up activities, focused respectively on quality and safety of care; digital
inclusion (informed by digital inclusion personas); staff wellbeing, training and
supervision; and technical and regulatory infrastructure.
METHODS Mixed-method, multi-site case study with co-design workshops and cross-sector
stakeholder events. 'Mixed methods', is defined as, "research in which … researchers combine
elements of qualitative and quantitative approaches … for the broad purposes of breadth and
depth of understanding and corroboration".
DELIVERABLES Range of patient/carer experience of remote, 4 digital inclusion workshops,
support for change in 10 GP practices, cross-case learning, 4 cross-sector stakeholder events
with follow-on support for policy action, academic papers and policy briefings, lay summaries
and resources.
