NCT05244941

Brief 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. 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

  1. 1.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.
  2. 2.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.
  3. 3.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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

October 27, 2021

Last Update Submit

March 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    through study completion, an average of 2 years

Study Arms (1)

Cross site-case study

Qualitative methods: semi-structured interviews for patients, front line clinical practitioners, and health system stakeholders, case study building across sites

Eligibility Criteria

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

General population

You may qualify if:

  • over 18
  • willing and able to provide informed consent
  • diagnosed with any relevant condition, receiving care from participating services

You may not qualify if:

  • inability to read or speak English unless a relevant translator is available
  • co-morbidity preventing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, United Kingdom

Location

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
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

February 17, 2022

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

August 31, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations