COVID-19NCT04435041
Remote-by-Default Care in the COVID-19 Pandemic
An observational study of COVID-19, run by University of Oxford at 1 site in United Kingdom.
Trial summary
18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2020to 28 Feb 2022
- How long will I take part?
- 1 Day
- 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: Mixed methods study
Who may be able to join
- 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'
Show all 10Show fewer
- Patients/carers who have crossed paths with community pharmacy primary care services during the COVID-19 pandemic.
- 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
- 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)
Who cannot join
- Patients or clinicians who are too ill to be interviewed
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote-by-Default Care in the COVID-19 Pandemic: Addressing the Micro-, Meso-, and Macro-level Challenges of a Radical New Service Model
18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro).
Read the detailed description
18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro). The methods are mainly qualitative (interviews, virtual ethnography, analysis of documents, micro-analysis of conversations) and are designed to inform action research.
Key deliverables:
At least two evidence-based assessment tools: qualitative (questions for remote assessment of breathlessness) and quantitative (a COVID-19-specific early warning score)
Transferable lessons about how to achieve rapid spread and scale-up, spread in real time through our extensive intersectoral networks
Strengthened infrastructure for supporting digital innovation in the NHS
- 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 |
|---|---|---|
| Remote assessment tools | Qualitative methods: semi-structured interviews for approx 40 front line clinical practitioners | |
| RECAP early warning score | Development of disease specific early warning score, building on earlier work through literature review and NEWS2 score | |
| Implementation/Scale up case studies | Study of implementation and scale up of remote-by-default at four different UK sites | |
| Infrastructure strengthening | Theory and data driven change effort involving policymakers, regulators, professional bodies, industry, patients and citizens with a view to overcoming interacting issues impacting success of digital projects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remote COVID-19 Assessment in Primary Care (RECAP) Early warning score
A set of questions and a predictive tool built into electronic records, designed to distinguish people with suspected covid-19 who need to go to hospital from those who can safely be monitored at home. The final Remote COVID-19 Assessment in Primary Care (RECAP) Early warning score score divides people into 'green' (stay at home, self-monitor), amber (professional monitoring e.g., via virtual wards with home oximetry), or red (assess in person promptly).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start13 May 2020
- Primary completion27 Jul 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Day
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
- NCT04435041
- Sponsor's protocol ID
- 283196
- Status last verified
- May 2020
- First submitted
- 16 Jun 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiorentino F, Prociuk D, Espinosa Gonzalez AB, Neves AL, Husain L, Ramtale SC, Mi E, Mi E, Macartney J, Anand SN, Sherlock J, Saravanakumar K, Mayer E, de Lusignan S, Greenhalgh T, Delaney BC. An Early Warning Risk Prediction Tool (RECAP-V1) for Patients Diagnosed With COVID-19: Protocol for a Statistical Analysis Plan. JMIR Res Protoc. 2021 Oct 5;10(10):e30083. doi: 10.2196/30083.
PubMed 34468322Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, Greenhalgh T. Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services. BMC Health Serv Res. 2020 Dec 20;20(1):1144. doi: 10.1186/s12913-020-06001-y.
PubMed 33342437Greenhalgh T, Thompson P, Weiringa S, Neves AL, Husain L, Dunlop M, Rushforth A, Nunan D, de Lusignan S, Delaney B. What items should be included in an early warning score for remote assessment of suspected COVID-19? qualitative and Delphi study. BMJ Open. 2020 Nov 12;10(11):e042626. doi: 10.1136/bmjopen-2020-042626.
PubMed 33184088
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote-by-Default Care in the COVID-19 Pandemic: Addressing the Micro-, Meso-, and Macro-level Challenges of a Radical New Service Model
- ClinicalTrials.gov ID
- NCT04435041
- Acronym / sponsor ID
- 283196
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Plymouth, Nuffield Trust
- Study start
- 13 May 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 17 Jun 2020 (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.
18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro).
Detailed description
18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro). The methods are mainly qualitative (interviews, virtual ethnography, analysis of documents, micro-analysis of conversations) and are designed to inform action research.
Key deliverables:
At least two evidence-based assessment tools: qualitative (questions for remote assessment of breathlessness) and quantitative (a COVID-19-specific early warning score)
Transferable lessons about how to achieve rapid spread and scale-up, spread in real time through our extensive intersectoral networks
Strengthened infrastructure for supporting digital innovation in the NHS
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remote assessment tools | – | –Qualitative methods: semi-structured interviews for approx 40 front line clinical practitioners |
| RECAP early warning score | – | –Development of disease specific early warning score, building on earlier work through literature review and NEWS2 score |
| Implementation/Scale up case studies | – | –Study of implementation and scale up of remote-by-default at four different UK sites |
| Infrastructure strengthening | – | –Theory and data driven change effort involving policymakers, regulators, professional bodies, industry, patients and citizens with a view to overcoming interacting issues impacting success of digital projects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mixed methods study
Key inclusion criteria (10 listed)
- 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.
- Staff involved in delivering remote pharmacist consultation services in the frontline or 'back offices'
Key exclusion criteria (2 listed)
- Patients or clinicians who are too ill to be interviewed
- -
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
Remote COVID-19 Assessment in Primary Care (RECAP) Early warning score
Time frame: 18 months
A set of questions and a predictive tool built into electronic records, designed to distinguish people with suspected covid-19 who need to go to hospital from those who can safely be monitored at home. The final Remote COVID-19 Assessment in Primary Care (RECAP) Early warning score score divides people into 'green' (stay at home, self-monitor), amber (professional monitoring e.g., via virtual wards with home oximetry), or red (assess in person promptly).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 34468322Fiorentino F, Prociuk D, Espinosa Gonzalez AB, Neves AL, Husain L, Ramtale SC, Mi E, Mi E, Macartney J, Anand SN, Sherlock J, Saravanakumar K, Mayer E, de Lusignan S, Greenhalgh T, Delaney BC. An Early Warning Risk Prediction Tool (RECAP-V1) for Patients Diagnosed With COVID-19: Protocol for a Statistical Analysis Plan. JMIR Res Protoc. 2021 Oct 5;10(10):e30083. doi: 10.2196/30083.
- Derived from this study: PubMed 33342437Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, Greenhalgh T. Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services. BMC Health Serv Res. 2020 Dec 20;20(1):1144. doi: 10.1186/s12913-020-06001-y.
- Derived from this study: PubMed 33184088Greenhalgh T, Thompson P, Weiringa S, Neves AL, Husain L, Dunlop M, Rushforth A, Nunan D, de Lusignan S, Delaney B. What items should be included in an early warning score for remote assessment of suspected COVID-19? qualitative and Delphi study. BMJ Open. 2020 Nov 12;10(11):e042626. doi: 10.1136/bmjopen-2020-042626.
Related trials for COVID-19
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
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 10 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: finished, as of the sponsor's last update on 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Remote COVID-19 Assessment in Primary Care (RECAP) Early warning score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435041, which also lists 3 linked publications.
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 11 Apr 2022.