NCT04435041

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 11, 2022

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

June 16, 2020

Last Update Submit

March 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    18 months

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mixed methods study

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • Patients or clinicians who are too ill to be interviewed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, United Kingdom

Location

Related Publications (3)

  • 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.

  • Ladds 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.

  • Greenhalgh 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 17, 2020

Study Start

May 13, 2020

Primary Completion

July 27, 2021

Study Completion

February 28, 2022

Last Updated

April 11, 2022

Record last verified: 2020-05

Locations