Remote By Default 2: Optimising the Remote-by-default Model in the United Kingdom (UK) General Practice (RBD2)

March 28, 2022 updated by: University of Oxford

Remote By Default 2: The New Normal

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. 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. 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. 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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

AIM: To inform a more fit-for-purpose remote-by-default model in UK general practice which takes account of a) quality and safety of care, b) equity and inclusivity, c) staff wellbeing and training, and d) the wider technical and regulatory infrastructure.

STRATEGIC OBJECTIVES

  1. PRACTICE LEVEL: Follow a sample of 10 GP practices for two years as they seek to introduce, improve and sustain remote-by-default consultations, supporting practices in developing effective remote services and equitable alternatives to remote where needed.
  2. PATIENT LEVEL: Capture the patient experience of remote-by-default consultations and ensure that this perspective is incorporated in practice- and system-level efforts to improve and augment remote-by-default services.
  3. SYSTEM LEVEL: Engage a wide range of stakeholders - including policymakers, the UKs National Health Service (NHS), professional bodies, industry, civil society and patient groups - in an ongoing dialogue about how to deliver and support a more equitable, less risky remote-by-default service.

OPERATIONAL OBJECTIVES

  1. PRACTICE LEVEL:

    1. Using an embedded researcher-in-residence model, build relationships with 10 GP practices selected for maximum variety in digital maturity, geographic location (e.g. urban/rural/remote) and population demographics. Support patient and public involvement (PPI) reps in those practices.
    2. Undertake interviews (up to 10 per practice) and collect documentary data (e.g. protocols, patient leaflets, workload data) from each practice to build a case study.
    3. Follow practice case studies longitudinally over time, supporting them to a) optimise quality and safety of care; b) ensure digital inclusion and provide equitable alternatives for the digitally excluded; c) maintain wellbeing and train and support their staff; d) overcome infrastructural hurdles (both technical and regulatory).
    4. Run two online co-design workshops for up to 40 people each (with hands-on activities in small groups), incorporating insights from patient/carer workshops (see below).
  2. PATIENT LEVEL:

    1. Recruit a diverse sample of 40 service users (patients and carers), most of whom will be registered with participating GP practices, with some identified through patient groups or snowballing, ensuring that the investigators include a range of people at risk of digital exclusion.
    2. Through narrative interviews (by phone, video or face to face as preferred), capture the patient/carer experience of remote-by-default consultations across four key quality and safety areas (long term condition monitoring, getting an appointment with own clinician, symptoms that could indicate early cancer, and complex multi-morbidity).
    3. Hold two co-design workshops (one remote and one face to face), each with up to 20 patients and carers, to generate insights about how digital inclusion impacts on access and quality and safety of care, and generate a range of 'digital inclusion personas'.
  3. SYSTEM LEVEL:

    1. Build relationships with key stakeholders (listed under strategic objective 3) through up to 30 elite interviews and extending our ongoing stakeholder map.
    2. Hold four large, cross-sector stakeholder events, including preparatory and follow-up activities, focused respectively on quality and safety of care; digital inclusion (informed by digital inclusion personas); staff wellbeing, training and supervision; and technical and regulatory infrastructure.

METHODS Mixed-method, multi-site case study with co-design workshops and cross-sector stakeholder events. 'Mixed methods', is defined as, "research in which … researchers combine elements of qualitative and quantitative approaches … for the broad purposes of breadth and depth of understanding and corroboration".

DELIVERABLES Range of patient/carer experience of remote, 4 digital inclusion workshops, support for change in 10 GP practices, cross-case learning, 4 cross-sector stakeholder events with follow-on support for policy action, academic papers and policy briefings, lay summaries and resources.

Study Type

Observational

Enrollment (Anticipated)

40

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

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

General population

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative experience of remote by default care access in the primary care setting in the UK
Time Frame: through study completion, an average of 2 years
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
Time Frame: through study completion, an average of 2 years
Support for cross stakeholder policy action, through creation of policy briefs, academic papers and resources
through study completion, an average of 2 years

Collaborators and Investigators

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

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)

September 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 300719

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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