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

March 31, 2022 updated by: University of Oxford

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mixed methods study

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Plymouth
Nuffield Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 283196

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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