COVID-19RBD2NCT05244941
Remote By Default 2: Optimising the Remote-by-default Model in the United Kingdom (UK) General Practice
An observational study of COVID-19, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population
Who may be able to join
- over 18
- willing and able to provide informed consent
- diagnosed with any relevant condition, receiving care from participating services
Who cannot join
- inability to read or speak English unless a relevant translator is available
- co-morbidity preventing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote By Default 2: The New Normal
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.
Read more
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
- 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.
- 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.
- 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.
Read the detailed 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
- 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.
- 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.
- 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
- PRACTICE LEVEL:
- 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.
- 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.
- 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).
- 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).
- PATIENT LEVEL:
- 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.
- 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).
- 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'.
- SYSTEM LEVEL:
- Build relationships with key stakeholders (listed under strategic objective 3) through up to 30 elite interviews and extending our ongoing stakeholder map.
- 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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross site-case study | Qualitative methods: semi-structured interviews for patients, front line clinical practitioners, and health system stakeholders, case study building across sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative experience of remote by default care access in the primary care setting in the UK
Iteratively develop support for change in 10 GP practices to inform a more fit for purpose model of remote by default care access in the primary care setting in the UK
Measured: through study completion, an average of 2 years
Support for cross stakeholder policy action on informing a fit for purpose remote by default care access in the primary care setting in the UK
Support for cross stakeholder policy action, through creation of policy briefs, academic papers and resources
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Sep 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth, Nuffield Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244941
- Sponsor's protocol ID
- 300719
- Acronym
- RBD2
- Status last verified
- Mar 2022
- First submitted
- 27 Oct 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote By Default 2: The New Normal
- ClinicalTrials.gov ID
- NCT05244941
- Acronym / sponsor ID
- RBD2 / 300719
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Plymouth, Nuffield Trust
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
Detailed 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
- 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.
- 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.
- 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
- PRACTICE LEVEL:
- 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.
- 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.
- 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).
- 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).
- PATIENT LEVEL:
- 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.
- 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).
- 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'.
- SYSTEM LEVEL:
- Build relationships with key stakeholders (listed under strategic objective 3) through up to 30 elite interviews and extending our ongoing stakeholder map.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross site-case study | – | –Qualitative methods: semi-structured interviews for patients, front line clinical practitioners, and health system stakeholders, case study building across sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (3 listed)
- over 18
- willing and able to provide informed consent
- diagnosed with any relevant condition, receiving care from participating services
Key exclusion criteria (2 listed)
- inability to read or speak English unless a relevant translator is available
- co-morbidity preventing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative experience of remote by default care access in the primary care setting in the UK
Time frame: through study completion, an average of 2 years
Iteratively develop support for change in 10 GP practices to inform a more fit for purpose model of remote by default care access in the primary care setting in the UK
Support for cross stakeholder policy action on informing a fit for purpose remote by default care access in the primary care setting in the UK
Time frame: through study completion, an average of 2 years
Support for cross stakeholder policy action, through creation of policy briefs, academic papers and resources
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative experience of remote by default care access in the primary care setting in the UK (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.