Remote-by-Default Care in the COVID-19 Pandemic: Addressing the Micro-, Meso-, and Macro-level Challenges of a Radical New Service Model
Conditions: COVID-19
Sponsor: University of Oxford

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FULL/LONG TITLE OF THE STUDY 
Scaling up Remote-by-Default Models of Care to Help Reduce the Spread of COVID-19 
 
SHORT STUDY TITLE / ACRONYM 
Remote by Default Primary Care 
 
PROTOCOL VERSION NUMBER AND DATE 
Version 8 22.03.21 
 
IRAS Number:   
283196 
Ethics Ref:  
20/EM/0128   
FUNDER: 
Economic and Social Research Council 
 
Chief Investigator 
Professor Trish Greenhalgh, Nuffield Department of 
Primary Care Health Sciences, University of Oxford 
Investigators 
Alex Rushforth 
Rebecca Rosen 
Catherine Pope 
Sara Shaw  
Richard Byng 
Chrysanthi Papoutsi 
Joseph Wherton 
Lucas Seuren 
Mona Koshkouei 
Sietse Wieringa 
Gemma Hughes 
Laiba Hussain 
Sarah Rybczynska-Bunt 
Claudia Leone 
Emma Ladds 
Sponsor 
University of Oxford 
 
SIGNATURE PAGE 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Chief Investigator agrees to conduct the study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other 
regulatory requirement. 
 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
 
I also confirm that I will make the findings of the study publicly available through publication or 
other dissemination tools without any unnecessary delay and that an honest accurate and 

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transparent account of the study will be given; and that any discrepancies from the study as 
planned in this protocol will be explained. 
 
Chief Investigator:  
Signature: 
...................................................................................................... 
 
Date: 
..22.../..03..../.20
21..... 
Name: (please print): TRISH GREENHALGH  
 
 
 
 
The chief investigator and all co-investigators declare no conflicts of interest.  
 
 
CONTENTS 
 
GENERAL INFORMATION 
Page 
No. 
TITLE PAGE  
1 
RESEARCH REFERENCE NUMBERS  
1 
SIGNATURE PAGE 
1 
LIST OF CONTENTS 
 
2 
KEY STUDY CONTACTS 
3 
ABBREVIATIONS 
3 
STUDY SUMMARY 
4 
FUNDING 
 
4 
ROLE OF SPONSOR AND FUNDER 
4 
PROTOCOL CONTRIBUTORS 
5 
 
 
SECTION  
1.  BACKGROUND 
 
5 
2. RESEARCH QUESTION/AIM(S)  
7 
3. STUDY DESIGN/METHODS 
8 
4. STUDY SETTING 
11 
5. SAMPLE AND RECRUITMENT 
12 
6. DATA MANAGEMENT 
15 
7. ETHICAL AND REGULATORY COMPLIANCE 
16 
8. DISSEMINATION  POLICY 
16 
9. REFERENCES 
17 
10. Amendment history  
17 

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KEY STUDY CONTACTS 
Chief 
Investigator 
Trish Greenhalgh 
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe 
Observatory Quarter, Woodstock Road, Oxford, OX2 6GG  
T: 01865  E: trish.greenhalgh@phc.ox.ac.uk 
Study  
Co-ordinator 
as above 
Sponsor 
University of Oxford, Clinical Trials and Research Governance., Joint Research 
Office, 1st Floor Boundary Brook House, Churchill Drive, Headington, OX3 7GB  
CTRG. T: 01865 616480  E: ctrg@admin.ox.ac.uk 
Funder(s) 
UKRI ESRC Covid-19 funding stream  
Key 
Protocol 
Contributors 
Alex Rushforth E: alexander.rushforth@phc.ox.ac.uk 
Trish Greenhalgh E: trish.greenhalgh@phc.ox.ac.uk 
Catherine Pope E: catherine.pope@phc.ox.ac.uk 
Rebecca Rosen E: rebecca.rosen@nuffieldtrust.org.uk 
Sara Shaw E: sara.shaw@phc.ox.ac.uk 
Richard Byng E: richard.byng@plymouth.ac.uk 
Chrysanthi Papoutsi E: chrysanthi.papoutsi@phc.ox.ac.uk 
Joseph Wherton E: joseph.wherton@phc.ox.ac.uk 
Lucas Seuren E: lucas.seuren@phc.ox.ac.uk 
Theresa Finlay E: theresa.finlay@phc.ox.ac.uk 
Sietse Wieringa E: sietse.wieringa@phc.ox.ac.uk 
Mona Koshkouei E: mona.koshkouei@phc.ox.ac.uk  
Sarah Rybczynska-Bunt E: sarah.rybczynska-bunt@plymouth.ac.uk 
Claudia Leone E: claudia.leone@nuffieldtrust.org.uk 
Laiba Husain: Laiba.husain@phc.ox.ac.uk 
Study 
Steering 
Group  
 
Anica Alvarez Nishio (Chair) a.alvareznishio@aya.yale.edu 
 
John Taylor (Patient representative on various primary care related projects) 
boltonuk@gmail.com 
 
Corina Cheeks (digital marketing manager) 
Debs Smith (patient – multimorbidities – done lots of PPI, including projects 
on wearables and Skype consultations) 
Eddie Duller (journalist, previously a member of Health and Wellbeing Board) 
Manzoor Ahmed (chemical engineer/biotech; now working with Royal Berks 
on digital projects inc. telemedicine and EPR – led to him spending a lot of 
time with patients and staff) 
 
ABBREVIATIONS 
CA 
Conversation Analysis 
CCG 
Clinical Commissioning Group 
CTRG Clinical Trials and Research Governance 

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CP 
Community Pharmacist 
ED 
Emergency Department 
EHC 
Emergency Hormonal Contraception 
GDPR General Data Protection Regulation 
GP 
General Practitioner 
HRA 
Health Research Authority 
IRAS 
Integrated Research Application System 
NHS 
National Health Service 
NHSE National Health Service England  
PMG 
Project Management Group 
PPI 
Patient and Public Involvement 
REC 
Research Ethics Committee 
SSG 
Study Steering Group 
WP 
Work Package 
 
STUDY SUMMARY 
 
Study Title 
Scaling up Remote-by-Default Models of Care to Help Reduce the 
Spread of COVID-19 
 
Short title 
Remote by Default Primary Care 
Study Design 
Qualitative and Quantitative (mixed method) 
Study Participants 
Clinical and non-clinical NHS primary care health care staff establishing 
hot hub and related remote-by-default services during the COVID-19 
pandemic and COVID-19 suspected patients/their carers who experience 
primary care services during the pandemic.  
Planned Size of Sample  Qualitative interviews (~60 clinical and non-clinical NHS health care and -
40 patients) 
Focus groups (4 x 15 people) and patient interviews (approx. 20) on 
experiences of accessing GPs remotely about ‘long’ Covid 
Online surveys of professionals and of patients ~ 400 respondents and  
follow up interviews with approximately 40 staff  
Video and audio recording of up to 20 remote consultations between 
clinicians and patients. 
Qualitative interviews ~ 75 pharmacy staff from ~4 community pharmacies 
in England consisting community pharmacy/ NHS health care and 25 of 
their patients) 
 
Planned Study Period 
2 years 
Aim 
1) To conduct a rapid evaluation that generates an up-to-date 
overview of existing and emerging video consulting services in 

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PROTOCOL CONTRIBUTORS 
Catherine Pope, Alex Rushforth, Rebecca Boden, Trish Greenhalgh, Richard Byng, Sara Shaw, 
Chrysanthi Papoutsi, Joseph Wherton, Lucas Seuren, Mona Koshkouei.  
 
 
 
STUDY PROTOCOL 
 
Scaling up Remote-by-Default Models of Care to Help Reduce the Spread of COVID: Rapid 
Evaluation of Primary Care ‘Hot Hubs’ and Longitudinal Follow-Up Action Research 
 
1. 
BACKGROUND 
 
COVID AND A RAPIDLY CHANGING NHS 
health care from clinicians and non-clinicians (e.g. service 
managers) with first-hand experience of setting up, running and/or 
working in video consultation services in primary and secondary 
care across the UK. 
2) To delineate what patients consider models of good practice for 
GPs managing ‘long Covid’ symptoms in a remote-by-default 
context 
3) Through in-depth longitudinal case studies, to support and inform 
the rapid implementation, spread and scale-up of remote-by-
default service models in primary care. 
4) Through detailed cross-sectional case studies, to support primary 
care clinicians in assessing symptoms remotely during the 
COVID-19 pandemic and in future. 
5) Describe the models of general remote pharmacist consultation 
practice,  to support and inform the rapid implementation, spread 
and scale-up of remote consultations in community pharmacy 
Research Question 
 
What is the new and emerging organisational, regional and national level 
context for video consulting in the COVID-19 pandemic? 
 
How can general practice best support and manage ‘long Covid’ in a 
remote-by-default context?  
 
How can action research, informed by complexity principles, support the 
rapid implementation, spread and scale-up of remote-by-default models of 
primary care in the Covid-19 crisis?  
 
How do health care professionals assess symptoms associated with 
COVID-19 by phone/video? 
 
How should community pharmacist remote consultations best be set up? 
 

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With a view to containing novel coronavirus (COVID-19), healthcare organisations in the UK (and 
beyond) are rapidly introducing new service models which avoid direct clinician-patient contact. This 
shift from in-person to remote consulting is the fastest and most extensive scale-up of a radical 
service innovation since the NHS was established in 1948. The change is logistical and cultural as 
well as technical. Clinicians are faced with a triple challenge: a new disease (uncertain, serious and 
highly contagious) and a new way of interacting with patients (e.g. individual or group video 
consultations) and major changes to team interactions, workflows and clinical pathways. These 
are challenging times. 
For the first time since the NHS began, it is impossible now to walk into a GP surgery and book an 
appointment. People must enter their symptoms online (or, if they are not digitally connected, by 
phone), and are then channelled through what is known as ‘total triage’ to either self-care, call-back 
(phone or video) from a clinician, or a face-to-face appointment in a ‘hot hub’ (most usually, to assess 
if their COVID is bad enough to need hospital admission).(NHS England, 2020. Accessed 31.3.20 at 
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/remote-total-triage-
model-in-general-practice-27-march-2020.pdf).  Alternatively, they can telephone NHS111, from which 
they could be referred for a GP call-back or sent direct to a hot hub. This complex arrangement, which 
was mandated by a recent national directive (NHS England, 2020. Accessed 31.3.20 at 
https://www.england.nhs.uk/coronavirus/primary-care/.) and is being variably interpreted in different 
localities, is likely to continue in some form for at least the next two years. This is not the case for 
community pharmacy. Patients are able to access pharmacy services to obtain their routinely 
prescribed medicines in addition to other common services such as: asking advice on side effects, 
minor ailments, smoking cessation and emergency hormonal contraception (EHC) as over the counter 
(OTC) treatment following a consultation with a pharmacist. With social distancing measures in place, 
reports of shortage of PPE in community pharmacies and debate on what is effective level of PPE 
during pharmacist consultations, and importance in containing the spread of the outbreak it is 
imperative that an alternative way of working is explored to allow continued accessibility for patients 
whilst protecting the public and professionals from the risk of infection. 
 
The hot hub model, supported with various forms of remote support including ‘virtual hot hub’ video 
monitoring of patients, is revealing tensions between the technological infrastructure of the NHS 
(especially interoperability between GP, out-of-hours and emergency ‘add-on’ electronic record 
systems), the professional networks through which responsibility for care is shared and distributed, 
and the material infrastructure of buildings, supply chains and so on. Infection control regulations, 
for example, list various standards for contagion hubs, including the quality of personal protective 
equipment (PPE) and the levels of ventilation needed to clear airborne viruses (partly for this reason, 
some ‘hot hubs’ are actually draughty tents erected in car parks). Logistical solutions (e.g. unmanned 
specimen dropboxes) have emerged to ensure that no two people meet in person unless unavoidable. 
There is a shortage of PPE in some hot hubs.  
Another aspect of the remote-by-default model is remote management of long-term conditions (LTCs). 
Many tried and tested technologies exist for this. ‘Florence’ (www.getflorence.co.uk), for example, is a 
chatbot text messaging service that prompts patients via their mobile phones (usually daily) to monitor 
their LTC (e.g. high blood pressure, diabetes, depression). A service evaluation in Scotland showed 
improvements in self-monitoring, patient satisfaction, access, service usage and disease control 

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(Alexander 2019) though research studies gave a mixed picture.(Kinnafick et al., 2016, Cottrell et al., 
2015a, Cottrell et al., 2015b, Unal et al., 2018) First-generation technologies like Florence are now 
seen as old-fashioned (they run on simple text messaging rather than smartphone apps; they don’t 
give patient an overview of their results; and they are not interoperable with electronic records). One 
development during the COVID crisis is the emergence of numerous next-generation technologies 
offering all the above features, but most developers are hazy about how their product will interface 
with NHS electronic records and new, virtual care pathways. 
At the same time as hot hubs and virtual consultations, through necessity primary care sites are also 
for the first time having to adopt new care in the community services (for Covid-suspected patients 
staying at home) linking to other organisations such as pharmacies, secondary and palliative care and 
local volunteer groups. In short, remote-by-default is a paradigm case of a disruptive innovation. It is 
complex, uncertain, challenging and risky. Furthermore, it is abruptly redefining what it means to be 
a patient, a doctor/nurse, a healthcare assistant and so on, and what it is to provide excellent 
healthcare.  
A later development in the Covid emergency has been the emergence of post-acute Covid-19 defined 
as extending beyond three weeks from the onset of first symptoms and chronic covid-19 defined as 
extending beyond 12 weeks (together these are heron referred to as ‘long Covid’). Since many 
people were not tested, and false negative tests are common, Greenhalgh et al have suggested that a 
positive test for covid-19 is not a prerequisite for diagnosis (Greenhalgh et al., 2020). This has 
however, brought new challenges to the remote-by-default care model that has emerged to deal with 
the crisis and whether it can effectively manage patients presenting with longer-term symptoms.  
We’d like to apply our expertise to the new challenges thrown up by the pandemic – specifically the 
question of how to achieve rapid spread and scale up of video consulting, and – longer term - 
new remote-by-default models in primary care. To do so, our study will consist of three components: 
a) A rapid evaluation phase that maps different types of video consulting activities, delivering 
rapid learning and feedback to sites and policymakers about what works well and what does 
not. 
b) A cross-sectional study of primary care sites across England, conducting micro-analysis of 
remote service models, delivering rapid feedback on how remote assessment works and can 
be improved. 
c) Longitudinal comparative case studies of primary care sites across England and Scotland, 
generating rich in-depth narratives of scale-up of remote-by-default models in primary care and 
the impacts on staff and patients.  
d) A rapid evaluation phase to describe the models of general remote pharmacist consultation 
practice; to examine whether the capacity they offer matches demand for appointments; to 
explore the factors which determine their quality and safety (for staff and patients).  
e)  
The sheer urgency of generating rapid learning and feedback on novel and potentially risky hot hubs, 
and the impending need for wider lessons about rapid scale-up of remote services as primary care 
approaches the ‘new normal’, justifies our three-pronged approach.  
 
2. 
RESEARCH QUESTIONS/AIMS  
 
Questions:  

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How can action research, informed by complexity principles, support the rapid implementation, spread 
and scale-up of hot hubs and related remote-by-default activities in the COVID-19 crisis? 
 
How do primary care clinicians assess symptoms associated with COVID-19 by phone/video? 
 
How have patients experienced GP services with respect to ‘long Covid’ symptoms and what are 
potential models of good practice in a remote-by-default context?  
 
How should community pharmacist remote consultations best be set up? 
 
How can action research, informed by complexity principles, support the rapid implementation, spread 
and scale-up of remote consultation models of community pharmacists in primary care in the Covid-19 
crisis? 
 
 
 
AIMS:  
1) Through a rapid evaluation, to generate an up-to-date overview of existing and emerging video 
consulting services in health care across the UK.  
2) Through in-depth longitudinal case studies, to support and inform the rapid implementation, 
spread and scale-up of remote-by-default service models in primary care. 
3) Through detailed cross-sectional case studies, to support primary care clinicians in assessing 
symptoms remotely during the COVID-19 pandemic and in future. 
 
Objectives  
In the context of COVID-19: 
 
1. To map existing and emerging video consulting services in UK health care. To share widely and 
quickly lessons on video consulting activities and to alert people to what doesn't work. 
2. In a sample of longitudinal case studies, surface and explore the technical, human/relational, 
material, organisational, ethical and regulatory challenges of shifting from a face-to-face to a remote-
by-default service model for general practice and other community-based services.  
3. Generate insights on how digital innovation can both support, and be supported by, a rapidly 
changing NHS infrastructure. 
4. Using participatory and co-design principles, support cross-sector deliberation and targeted action, 
thereby addressing priority infrastructural challenges.  
5. To find out how clinicians are currently assessing symptoms associated with COVID-19 (e.g. 
breathlessness) when using video/phone consultation and to understand subjective sense-making, 
words and terms used and responses to assessment questions. 
6. To identify the needs for the type of services and equipment required to carry out remote 
consultations from community pharmacy.  
7. To identify the varieties of remote consultations models emerging in community pharmacy practice. 
8. To share widely and quickly, lessons on pharmacist remote consultation models that work and to 
alert professionals as to what doesn't work. 
 
 
3. STUDY DESIGN / METHODS  
 

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Multi-site case, mixed method study with action research. We will use a combination of methods in a 
pragmatic, reflexive and theory-informed way to generate data, synthesise and share it with 
participating teams, and inform both team- and wider system learning.  
 
In late March a non-scientific, straw-poll survey to gather information about primary care hot hubs was 
conducted by the study chief investigator, TG, through Twitter, attracting over 300 responses from 
GPs in 24 hours. For the rapid evaluation and feedback stage, we will produce a new online 
survey, using hypothesis-driven questions to generate an updated and theory-driven overview of video 
consulting activities. We will seek to enrol clinicians and non-clinicians (e.g. service managers and 
stakeolders) with first-hand experience of setting up, running and/or working in video consultation 
services in primary and secondary care across the UK., via Twitter and professional networks. Those 
that complete the survey will be given the option of leaving their emails to be contacted for a follow-up 
interview. We will use qualitative methods to conduct follow-up interviews with approximately 40 
survey respondents (up to 10 in each of the devolved nations), ensuring a diversity of sites, clinical 
settings, video consultation services and platforms. Participants can signal via verbal consent forms 
whether they are willing to reconnect for a second interview 8-12 weeks later to capture and reflect on 
changes over time. 
 
In early April a number of pharmacists, pharmacy professional bodies and digital companies offering 
video consultation platforms were contacted for a non-scientific, information gathering exercise to 
identify a need for alternative ways of working in community pharmacy during the pandemic and 
possible digital platforms available for immediate use or rapid development for this purpose. We will 
seek to enrol Pharmacists with first-hand experience of establishing and/or using remote consultation 
technology, via Twitter and professional networks. Those that complete the survey will be given the 
option of leaving their emails to be contacted for a follow-up interview. 
 
For longitudinal part of this study, our over-arching ‘case’ is the UK National Health Service. Within 
that case, we will study five primary care sites (three in England, one in Wales, one in Scotland), 
representing maximum diversity in how the remote-by-default model is understood and implemented 
on the ground. Our cases will be technology-agnostic in that we will study the technologies that are 
being contemplated and used by locality-based teams, rather than setting out to ‘test’ particular 
technologies. Given current circumstances, remote interviews and remote ethnographic observation 
accompanied by analysis of documents (e.g. pathways, emails, websites) will be our primary methods. 
We will use these approaches in a pragmatic, reflexive and theory-informed way to generate data, 
synthesise and share it with participating teams, and inform both team- and wider system learning.  
We will identify cases via our professional networks and via the online survey, ‘snowballing’ from our 
initial contacts to others in their organisations. We aim to interview staff from a range of roles, including: 
senior clinical leaders; front line 'Covid/suspected Covid clinicians'; clinicians seeing non-Covid patients 
and back office and support staff (some of these will be providing support in reception or technical 
support). We will ask open-ended questions about the emergence of new work routines, patient flows 
and pathways, assessment methods, patient-clinician interactions and aspects of NHS infrastructure 
that support or inhibit their work. We estimate that we will conduct approximately 60 interviews with NHS 
staff by phone/using online video (e.g. MS Teams, Skype), or near verbatim notes will be made 
contemporaneously.  

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Alongside staff interviews, we will remotely interview approximately 20 patients/their carers who have 
recently crossed paths with primary care remote-by-default services during the crisis (e.g. hot hubs, 
individual and group video consultations, remote monitoring, care in the community), asking open ended 
questions to understand subjective sense-making and mapping their pathways. Volunteer patients will 
be sought via advertising on social media. Further to this, we will conduct and video record (via Zoom 
or MS Teams) 4 virtual focus groups, two with approximately 15 patients,, and another two with 
approximately 15 clinicians with confirmed or suspected diagnosis of ‘long Covid’ about encounters with 
primary care and related services regarding access and quality of care. For those unable or 
uncomfortable with participating in a focus group, we will offer the option of one-to-one interviews instead 
(approximately 20 patients and 20 clinicians). Data sources will include ethnographic fieldnotes (~100h 
per case) of local practice team meetings, training sessions and stakeholder engagement meetings, 
providing naturalistic insight into acceptability of digital technology among professionals and 
stakeholders. Participants are likely to include members of a typical GP practice team, clinical, 
administrative, and external stakeholders (e.g. vendors, related clinical services, external trainers). 
 
In the pharmacy element of the project, we will ask frontline teams (e.g. pharmacists and pharmacy 
technician and dispensers) to recruit and issue a survey via an online link to approximately 25 
patients/their carers from each pharmacy research site who have recently crossed paths with 
pharmacist remote consultation services during the crisis (e.g. individual (EHC consultations) video 
consultations, group video consultations (e.g. smoking cessation support groups), remote 
monitoring/medication reviews, support of other professional services e.g. care/advice to care homes), 
asking open ended questions to understand subjective sense-making and mapping their pathways. 
 
All staff and patient participants will be given the option via the consent form of indicating whether they 
are willing to be contacted for a second interview, with details laid out in the participant information 
leaflet. This will help us to track fast evolving changes longitudinally. Audio/video recorded interviews 
will be transcribed and de-identified. All data collection will be undertaken by experienced qualitative 
researchers.   
In the context of group video consultations, we will recruit patients who have taken part in virtual group 
clinics to provide feedback through an online survey. The survey link will be shared with patients by 
their clinicians at the end of the virtual consultation. We expect to collect 300 responses which will 
feed into iterative adaptations of remote-by-default models of care. Patients who complete the survey 
will be given the option of leaving their contact details for follow-up research.    
 
We will work with primary care clinicians to record video consultations and telephone consultations for 
detailed conversation analysis. For video consultations, we will use videoconferencing systems in 
place and approved for use in the respondent’s NHS practice setting. For telephone consultations, 
clinicians will use established telephone services. We will then conduct conversation analysis of the 
video- and audio-recorded consultations to investigate how clinicians assess symptoms associated with 
COVID-19 in practice and how patients make sense of the procedure. Recordings will be transcribed by 
using specialised transcription systems to capture both the spoken and non-verbal communication. 
Through repeated viewing and tagging of the data we will identify the communication strategies used to 
assess the symptoms – focusing on questions and assessment tools/scores they use and how they use 
them. We will then investigate how these different strategies affect the responses by patients – whether 
they can follow the instructions or experience problems describing symptoms, and if so, what types of 

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problems and how those are subsequently managed. Participants -both clinicians and patients -will have 
the option to remain identifiable or be de-identified using established techniques that allow replay of 
sound and obscured ‘greyscale’ images that show outlines/blurred head and shoulders, and 
backgrounds (this allows analysis of gestures and movement but does not reveal identity). All identifying 
information will removed from the audio streams with specialised software (Adobe Premiere Pro). 
 
 
Data Analysis 
 
Interview, observational, focus group and document data analysis will be informed by established 
qualitative approaches for thematic analysis (moving from coding through thematic analyses to build 
causal explanations). Software such as Atlas.ti or NVivo may be used for data archiving and 
management.  
 
Video and audio recordings of consultations will be analysed using conversation analysis, a data-
driven methodology that uses recordings of naturally occurring interaction to (inductively and 
incrementally) conduct detailed micro-analytic studies of the verbal and non-verbal communication 
strategies used in conversation. Specialised software such as Transana (see figure 1) will be used for 
data transcription, tagging, and management. 
 
Quantitative data will be aggregated and analysed using basic statistical methods.  
 
Analysis will be undertaken by a core analytical team and will include PPI members.  The project steering 
group will provide virtual comments on the themes emerging from the data and to consider the veracity 
and credibility of interpretations. 
 
Figure 1 Transana workspace with anonymised recording of video consultation 
 
4. 
STUDY SETTING 
 
The video consulting survey will be shared with NHS organisations across the United Kingdom. The 
pharmacy survey will be shared with pharmacists across the United Kingdom.  

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For the case studies, four primary care sites will be approached (three from England, one from Wales 
and one from Scotland), in addition to four community pharmacy sites in England. Our intention is to 
build a collection of sites that represent maximum diversity in how the remote-by-default model is 
understood and implemented on the ground, as well as trying to capture differences in geographical 
setting, jurisdiction, and demography.  
The patient online survey will be  provided to the participating pharmacy sites for recruitment.   
 
5. 
SAMPLE AND RECRUITMENT 
 
Inclusion criteria for interviews 
 
Willing and able to give informed consent for participation 
 
Aged 18 years or above 
 
Staff involved in delivering remote-by-default services in the frontline or ‘back offices’ 
 
Patients/carers who have crossed paths with primary care services during the Covid pandemic. 
 
Pharmacy case studies: 
 
Staff involved in delivering remote pharmacist consultation services in the frontline or ‘back offices’ 
 
Patients/carers who have crossed paths with community pharmacy primary care services during the 
COVID-19 pandemic. 
 
 
Inclusion criteria for video and telephone consultations 
 
Patients who have remote primary care consultation regarding symptoms associated with COVID-19 
and their clinicians (based in Oxford/Thames Valley) who have agreed to participate in the study  
 
Inclusion criteria for focus groups 
 
Patients that have experienced self-reported ‘long Covid’ symptoms (for patient only focus groups) 
 
Clinicians that have experienced self-reported ‘long Covid’ symptoms (for clinician only focus groups) 
 
Exclusion criteria  
 
Patients or clinicians who are too ill to be interviewed  
 

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Sampling technique:  
 
In the evaluation phase we will use convenience sampling to conduct an online survey of NHS staff 
professionals video consulting services. For the community pharmacist remote consultations the 
evaluation phase will use convenience sampling to conduct an online survey of community pharmacy 
primary care professionals setting up and running pharmacist remote consultations. 
 
For the second phase, we will use theoretical sampling to select four primary care sites (three in 
England, one in Wales and one in Scotland), and four community pharmacy sites, that represent 
maximum diversity in how the remote-by-default model is understood and implemented on the ground, 
as well as trying to capture differences in geographical setting, jurisdiction, and demography.  
 
Researchers will interview pharmacy participants at each of the pharmacy sites by telephone or video. 
The mode of interview will be chosen by the participant as so what is most convenient to them. There 
will be two interviews each of 60 minutes maximum.  Where researchers are to directly observe a 
remote consultation with a patient/carer, verbal consent will be obtained by the pharmacist conducting 
the consultation from the patient/carer for the researcher to be present as an observer within the 
consultation. The length of the consultation will be determined by the needs of the patient/carer and 
the pharmacist conducting the consultation. 
 
Recruitment: The online survey will be advertised via Twitter and professional networks, where they can 
follow a link onto the online survey tool and, if they wish, leave details to be contacted about an interview.  
 
For interviews and focus groups, we will advertise across Twitter and our professional networks. 
Participants will be invited to contact a member of the research team with their email or phone number, with 
a University researcher getting in touch. For virtual ethnographic observation of meetings in the case 
studies, the research team will request access through the chair of the meeting, who will be asked to share 
with attendees our participant information sheet and a short description about the study and why we want 
to attend and raise our request as an agenda item at their next meeting.  
 
For the video and telephone consultation recordings, clinicians will be invited to participate by a member of 
the research team (by email, phone or social media direct message) to clinicians in existing professional 
networks including CRN and PCN. Clinicians will select patients who make an appointment for COVID-19 
related symptoms. 
 
Consent: Interview and focus group participants will receive a participant information leaflet by email 
prior to the interview or focus group and will be asked by a University researcher to provide oral consent 
at the start of the interview or focus group. In the case of a participant being deaf or hard of hearing an 
interpreter will be used. In the case of a participant having low literacy levels, ‘easy read’ versions of 
documents will be provided. The Researcher will record the consent on a “record of verbal consent 
form”. A copy of the form will be forwarded to the participant by post or email at the completion of the 
interview or focus group. 
Participants will have opportunities to ask questions during the interview or focus group and afterwards via 
email or phone to the researcher.  

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For ethnographic observation of meetings in our case study sites, the chair will consult with attendees (see 
‘Recruitment’ above). Researchers will not be present at the time the item is discussed. The group will use 
its own procedures to decide whether to accept the request or not. If the group decides that they are happy 
for us to observe, we will attend the subsequent meeting of the group as observers and take handwritten 
field notes without tape recording. The agreement of the group to participate in the study will be recorded in 
the minutes. A copy of the minutes will be retained by the research team at the University of Oxford.  
 
 
Between 5-6 clinicians will record consultations involving symptoms associated with COVID-19 using 
videoconferencing systems in place and approved for use in their NHS practice setting or telephone, 
having consented to do this when invited to participate by a member of the research team. In the 
pharmacy element of the study, 8 -12 clinicians (pharmacists) will record the remote consultations with 
patients with any condition using videoconferencing systems in place and approved by their 
organisation, having consented to do this when invited to participate by a member of the research team. 
We will invite clinicians to participate in the study by recording one or more video consultations. If they 
are open to the idea, we will provide them with the Participant Information Sheet. We will contact them 
seven days later by phone/videoconferencing to secure consent verbally.  Researchers will provide them 
with a copy (password-protected via email).  
 
At the start of the consultation, the clinician will record the patient’s consent for the consultation to be 
recorded. If the patient consents, the clinician will initiate the recording. If the patient does not consent, 
no recording will be made.  
 
At the end of the consultation, the clinician will inform the patient briefly about the study, and that we 
want to include the video-recording or audio-recording of the consultation in the study. If this is not 
acceptable to the patient, the recording will be deleted.  
 
If the patient is open to this idea, the clinician will provide the patient with a link to a website containing 
the Participant Information Sheet, and ask whether they are happy to be approached by a researcher.  
If so, they will obtain permission to provide researchers with the patient’s contact information.  
 
A researcher will then contact the patient by phone/videoconferencing  and explain the study in more 
detail. If they agree to participate, the researcher will go through the verbal consent form with them, 
and provide them with a copy (password protected via email).  
Video- and audio-recording consultations places a burden on the participants in terms of the access 
given to the videographer. However, in a previous study of a similar nature, (REC ref: 13/EM/0370), 
we found that participants were happy to volunteer to be recorded and have raw data be used for 
analysis. 
 
 
Withdrawal of participants  
 
 
Participants may withdraw from the study at any point but data obtained up until the point of the 
withdrawal will be retained for analysis.  
 

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Definition of End of Study 
 
The end of the study is the point at which all study data has been collected by the University researcher. 
 
6. 
DATA MANAGEMENT 
 
No patient records will be collected for this study. Video and audio recordings with identifying information 
will be de-identified if participants do not consent to the identifying information being used. Digital data 
(e.g. interview, focus group and video consultation audio/video recordings) will be transferred to 
password protected storage on University computers / servers as soon as possible and de-identified. 
 
7. 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
This is a low risk study involving NHS staff and patients. It is possible that the staff might disclose 
evidence of poor practice (either theirs or colleague/institutions) during interview.  Should we suspect 
or detect poor practices we will immediately discuss this within our core team (which includes practising 
clinicians) and if necessary communicate straight away with the relevant regulatory authority. For patient 
interviews and focus groups researchers will take care to establish fitness to take part, and recommend 
the patient call 999 if they significantly deteriorate during the interview. There are no direct benefits to 
participants but knowledge gathered will inform policy and practice dealing with Covid-19 pathways in 
primary care.  
 
Assessment and management of risk 
The research team include clinical and non-clinical researchers. The investigation will be conducted 
remotely, so researchers will not come into physical contact with participants who have or may have an 
infection, so there is no risk of disease transmission. Researchers will comply with research best practice 
and local policies regarding safeguarding. Non-clinical researchers will seek advice from local 
clinicians/managers as appropriate should issues arise. Clinically trained researchers will follow 
regulatory /governance policies pertaining to their professional status/ registration.  
 
Research Ethics Committee (REC) and other Regulatory review & reports 
Following Sponsor approval, the protocol, informed consent form, participant information and other 
relevant documents e.g. advertisements will be submitted to an appropriate Research Ethics 
Committee (REC), HRA, and host institution(s) for written approval. 
The Investigator will agree substantial amendments with the Study Steering Group. They will submit 
and, where necessary, obtain approval from the above parties for all substantial amendments to the 
original approved documents. 
 
All correspondence with the REC will be retained. The Principal Investigator will oversee the submission 
of reports as required and notify the REC of the end of the study. If the study is ended prematurely, the 
Principal Investigator will notify the REC, including the reasons for the premature termination. Within 
one year after the end of the study, the Principal Investigator will submit a final report with the results, 
including any publications/abstracts, to the REC.  
 
Data protection and patient confidentiality  

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All investigators, research staff, and steering group members will comply with the requirements of the 
Data Protection Act 2018 and General Data Protection Regulation (GDPR) 2016/679 with regards to 
the collection, storage, processing and disclosure of data including any personal information. The 
Principal Investigator (Greenhalgh) is the data custodian.  University of Oxford is the data controller. 
 
At the end of the study data (including consent forms) will be stored for 10 years in accordance with 
University of Oxford policy and then destroyed. After the 10 year retention all research data (including 
consent forms) will be securely destroyed using the appropriate procedure advised at that time by the 
University of Oxford research data team. Any personal identifiers relating to individual participants will 
be held for less than six months after the end of this 24 month study.  
 
Indemnity 
Insurance and indemnity arrangements lie with the sponsor (University of Oxford).  The University of Oxford 
maintains Public Liability and Professional Liability insurance, which will operate in this respect.  
 
Access to the final study dataset 
Greenhalgh, Rosen, Rushforth, Byng, Shaw, Pope, Papoutsi, Wherton, Seuren, Wieringa, Finlay, 
Hughes, Husain, Koshkouei, Leone, Ladds, and Rybczynska-Bunt will have access to the full dataset. 
De-identified data will be shared with additional investigators who join the team. Use of de-identified 
data for research or teaching will only be undertaken with the consent of the participants. Direct 
access will be granted to authorised representatives from the Sponsor or host institution for monitoring 
and/or audit of the study to ensure compliance with regulations. 
 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
Contractual arrangements 
None. 
 
8. 
DISSEMINATION POLICY 
 
Final report synthesising the findings which will also be presented via academic peer-reviewed publications 
(including rapid publications in BJGP or BMJ if possible) and appropriate conferences and meetings, 
regular lay summaries to participating practices and relevant national groups such as RCGPs.    
 
Outputs 
a) Targeted Dissemination - Feedback meetings with health professionals and stakeholders; Public and 
patient facing feedback; Website and social media. 
b) Final Report and papers: open access where funding and journal allows, and prepublication copies will 
be available from the study team and in University repositories.  
c) Archive of de-identified data for further research/teaching  
 
Archiving  
Where possible and subject to relevant consents qualitative data will be de-identified, archived and 
made available for reuse/secondary analyses. Ownership of IP generated by employees of the 

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University vests in the University. The University will ensure appropriate arrangements are in place as 
regards any new IP arising from the study, conforming to contractual arrangements specified by the 
Funder. 
 
9. 
REFERENCES 
 
ALEXANDER, H. 2019. Towards Scaling Up Home and Mobile Health Monitoring 2015-2018. An 
evaluation of the outcomes achieved by Year 3 and progress towards scale-up, spread and 
sustainability, Edinburgh, Scottish Government Technology Enabled Care Programme. 
COTTRELL, E., COX, T., O'CONNELL, P. & CHAMBERS, R. 2015a. Implementation of simple 
telehealth to manage hypertension in general practice: a service evaluation. BMC Fam Pract, 
16, 83. 
COTTRELL, E., COX, T., O'CONNELL, P. & CHAMBERS, R. 2015b. Patient and professional user 
experiences of simple telehealth for hypertension, medication reminders and smoking cessation: 
a service evaluation. BMJ Open, 5, e007270. 
GREENHALGH, T., KNIGHT, M., A’COURT, C., BUXTON, M. & HUSAIN, L. 2020. Management of 
post-acute covid-19 in primary care. 370, m3026. 
KINNAFICK, F. E., THOGERSEN-NTOUMANI, C. & DUDA, J. 2016. The effect of need supportive text 
messages on motivation and physical activity behaviour. J Behav Med, 39, 574-86. 
NHS ENGLAND 2020. Accessed 31.3.20 at https://www.england.nhs.uk/coronavirus/primary-care/. 
COVID-19 primary care operating model and implementation. Publications approval reference: 
001559, London, NHS England. 
NHS 
ENGLAND 
2020. 
Accessed 
31.3.20 
at 
https://www.england.nhs.uk/coronavirus/wp-
content/uploads/sites/52/2020/03/remote-total-triage-model-in-general-practice-27-march-
2020.pdf. Advice on how to establish a remote ‘total triage’ model in general practice using online 
consultations, London, NHS England. 
UNAL, E., GIAKOUMIDAKIS, K., KHAN, E. & PATELAROU, E. 2018. Mobile phone text messaging for 
improving secondary prevention in cardiovascular diseases: A systematic review. Heart Lung, 
47, 351-359. 
 
 
10. 
Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
1 
2 
13.05.20 
Lucas 
Seuren  
Alex 
Rushforth 
 
Protocol Sections: 
 
1: Added one research objective (now 
(b)) 
2: Added one research question (3), one 
aim (3), and one objective (6) 
3: Added description of workpackage1: 
how we will record video consultation, 
procedure for making the recordings, 
securing consent, where appropriate de-
identify the recordings, and conduct the 
conversation analysis of the recordings. 
5: Added inclusion criteria, recruitment 
method and consent procedure for 
recordings of video consultations 

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6: Added sentence how we will manage 
identifying 
information 
from 
video-
recordings of video consultations 
7: Added output that we archive data for 
further 
research/teaching 
(video-
recordings of video consultations) 
 
2 
3.0 
13.08.20 
Alex 
Rushforth 
Protocol sections: 
Study Summary: modified one aim of the 
study, one research question, one 
sample size. 
Section 2: Aims – question 1 changed; 
Objectives – 1 and 2 changed 
Section 
3: 
Study 
design/method 
description 
changed 
in 
second 
paragraph 
Section 5: Sampling technique – 1st 
paragraph changed; Recruitment – 1st 
paragraph changed 
3 
4.0 
17.08.20 
Alex 
Rushforth 
Protocol sections: 
Study Summary: Added to planned 
sample 
size, 
aims, 
and 
research 
question. 
Section 1: Added to background on long 
Covid 
Section 2: Added research question. 
Section 3: Added focus groups and 
interviews to study design and data 
analysis description.  
Section 
5: 
Added 
focus 
group 
information to inclusion and exclusion 
criteria, 
consent 
procedure, 
and 
recruitment details.  
Section 
6: 
Added 
focus 
group 
information 
to 
data 
management 
description 
Section 
7: 
Added 
focus 
group 
information to ethical and regulatory 
considerations. 
Section 9: Added long Covid reference 
4 
5.0 
08.09.20 
Mona 
Koshkouei  
Alex 
Rushforth 
1- Study summary section. Planned 
sample 
sizes 
for 
the 
pharmacist/pharmacy 
recruitment 
updated 
to 
75 
clinicians and 5 patient/carers.  

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2- Section 
1: 
background. 
Pharmacy objective added as 
point d).  
3- Section 3: study design/methods 
and section4: study settings. 
Pharmacy sections integrated 
into full text of body and 
individual paragraphs removed. 
4- Patient consent process added 
for pharmacy recruitment for 
videoconferencing 
and 
recording.  
Protocol updated throughout to reflect 
pharmacist 
inclusion 
in 
the 
term 
‘clinician’. 
List of investigators updated throughout 
protocol to include new recruits into 
research study team.  
5 
6.0 
08.10.20 
Alex 
Rushforth, 
Sarah 
Rybcynska-
Bunt 
Changes to protocol in: 
 
Section 3 – Added description of 
ethnographic 
observation 
to 
the 
subsections on design, methods and 
data analysis. 
 
Section 5 - Added description of 
ethnographic 
observation 
to 
the 
subsections on recruitment and consent. 
6 
7.0 
01.03.21 
Lucas 
Seuren, Alex 
Rushforth 
Protocol updated throughout to reflect 
inclusion 
of 
audio-recordings 
of 
telephone consultations, in addition to 
video-recordings of video consultations. 
7 
8 
22.03.21 
Stuart 
Faulkner, 
Alex 
Rushforth 
Protocol updated throughout to reflect 
revised or additional consent and PIL 
documentation to account for interviews 
of deaf or hard of hearing participants 
who may need a translator, and those 
who may be low literacy. 
 
List details of all protocol amendments here whenever a new version of the protocol is produced. 
Protocol amendments must be submitted to the Sponsor for approval prior to submission to the REC. 
 
 
 
 
 

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