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Remote-by-Default Care in the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435041
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
University of Plymouth
Nuffield Trust
Information provided by (Responsible Party):
University of Oxford

Brief 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. 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).

Condition or disease
COVID-19

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 103 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : May 13, 2020
Actual Primary Completion Date : July 27, 2021
Actual Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mixed methods study
Criteria

Inclusion Criteria:

  • 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435041


Locations
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United Kingdom
University of Oxford
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
University of Plymouth
Nuffield Trust
  Study Documents (Full-Text)

Documents provided by University of Oxford:
Study Protocol  [PDF] March 22, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04435041    
Other Study ID Numbers: 283196
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases