Exploring the current use of remote assessment questionnaires in outpatient services to assess the feasibility of standardisation

ISRCTN ISRCTN13316603
DOI https://doi.org/10.1186/ISRCTN13316603
IRAS number 356413
Secondary identifying numbers CPMS 69675, NIHR206835
Submission date
23/09/2025
Registration date
23/10/2025
Last edited
23/10/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Remote assessment questionnaires are increasingly being used by outpatient services in the NHS. They are questionnaires that are completed by patients at home in between their normal hospital appointments. They mainly ask about patient health and will often include one or more patient-reported outcomes (PROMs). However, they may also include other questions or information, such as questions about patient experiences or care needs or information about the outpatient service.

These remote assessment questionnaires (RAQs) aim to help doctors make decisions about whether, when and how to provide patients with their care, and they may cover a wide range of different topics. At present, the questions that are included in the RAQs are often chosen by each outpatient service. The problem with each service choosing its own questions for the RAQs is that they may not choose the “best” questions, which have been properly tried and tested. If questions have not been carefully designed, they may lead to patients providing incorrect information, leading to poor decisions about their care or treatment needs. The GENESIS study wants to know more about the different ways in which RAQs are being used in outpatient care. The study will also investigate how RAQs can be used to best support patient care and whether a common approach would be possible and beneficial.

Who can participate?
Adults over 18 years who are healthy volunteers, patients, carers, members of the public, healthcare staff working in outpatient care, and staff working in health information governance.

What does the study involve?
GENESIS is running different research activities online to collect the views of patients and members of the public, outpatient staff and people who manage health information. Participants can choose to take part in all or some of the following activities:
1. An online questionnaire to understand different views on remote assessment questionnaires and people’s experiences of using or completing them.
2. Online interviews/focus group to discuss in more detail people’s views on remote assessment questionnaires and what should be included in them.
3. An online Delphi survey to agree on how best to use these questionnaires in the future and what sort of content should be included as standard.

What are the possible benefits and risks of participating?
For most GENESIS research activities, there are no direct benefits to taking part, although it is hoped that the study will provide information on how to develop and use RAQs to better support patient care in the future. Interview participants will have the option of receiving a £15 voucher (Love2shop or Amazon) by email to thank them for their time.

This is a low-risk study that is collecting people’s views on the use of remote assessment questionnaires.

Where is the study run from?
The University of Liverpool, UK.

When is the study starting and how long is it expected to run for?
December 2024 to November 2026.

Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) Programme, UK

Who is the main contact?
Study coordinator: Anna Kearney: A.kearney@liverpool.ac.uk

Study website

Contact information

Dr Anna Kearney
Public, Scientific

Study coordinator
Department of Health Data Science
University of Liverpool
Waterhouse Building, Block F
1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom

ORCiD logoORCID ID 0000-0003-1404-3370
Email a.kearney@liverpool.ac.uk
Dr Susanna Dodd
Principal investigator

Principal investigator
Department of Health Data Science
University of Liverpool
Waterhouse Building, Block F
1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom

ORCiD logoORCID ID 0000-0003-2851-3337
Email s.r.dodd@liverpool.ac.uk
Dr Keith Bodger
Principal investigator

Chief clinical investigator
Department of Health Data Science
University of Liverpool
Waterhouse Building, Block F
1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom

ORCiD logoORCID ID 0000-0002-1825-3239
Email kbodger@liverpool.ac.uk

Study information

Study designMixed-methods observational study
Primary study designObservational
Secondary study designQuestionnaire, interview or observation study
Study setting(s)Home, Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA GENEric Standardised Item Set for remote assessment questionnaires in outpatient services
Study acronymGENESIS
Study objectivesTo explore the current use of remote assessment questionnaires (RAQs) in outpatient services, to assess the feasibility of standardising RAQs and to develop guidance around RAQ development and use to better support patient care.
Ethics approval(s)

Approved 10/09/2025, West Midlands - South Birmingham Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8029 ; southbirmingham.rec@hra.nhs.uk), ref: 25/WM/0176

Health condition(s) or problem(s) studiedGeneric health relevance
InterventionQualitative research methods will be used to explore current practices around remote assessment questionnaires (RAQs) and views on when a standardised approach may be of benefit. Three key stakeholder groups (patients/public, healthcare professionals working in outpatient services and those working in health informatics/ health data governance) will be invited to take part in the following research activities. They can choose to take part in one, some or all.

- Online questionnaire to explore current practices around the use of RAQs in outpatient care (including the experiences of patients and public completing RAQs).

- Semi-structured qualitative interviews to explore areas for standardisation in RAQs content and best practices for RAQS.

-A modified Delphi (two-part survey) to gain agreement across stakeholders on what areas of RAQ content should be standardised across and within specialities. It will also gain agreement on statements around best practices for RAQ development and implementation. The Delphi survey will use results from the online questionnaire and interviews in order to develop a long list of items for participants to vote on in the first part of the survey.

Blank examples of RAQs will be collected to review content and the types of questions included in RAQs (e.g. topics, validated questions). This will be used to develop a classification system for different RAQs according to their content/reason for use. Blank examples of RAQs will be collected via the questionnaire, through professional networks and word of mouth.
Intervention typeOther
Primary outcome measureRemote assessment questionnaires (RAQs) practices and the potential for a standardised approach to their development and implementation will be measured using data collected during the online questionnaire, semi-structured qualitative interviews and Delphi survey during the study

Secondary outcome measures1. Current approaches to RAQs within the NHS, including variations in use cases, content, and development methods
2. Taxonomy for RAQ classification based on use case and content
3. Consensus on aspects of RAQs that may benefit from a standardised approach
4. Guidance for RAQ development and use, such as a toolkit
5. Template RAQ for outpatient services to support new questionnaire development or refinement of existing ones
Overall study start date01/12/2024
Completion date30/11/2026

Eligibility

Participant type(s)Carer, Health professional, Healthy volunteer, Patient
Age groupAdult
SexAll
Target number of participantsPlanned Sample Size: 160; UK Sample Size: 160
Key inclusion criteria1. Adult patients, carers and members of the public who have experience of outpatient care within the NHS
2. Clinical staff (incl. allied health professionals) working in NHS outpatient services
3. Those with a professional role in health information governance, either within an NHS trust (e.g. Chief Clinical Officers), or within a supporting organisation such as NHS England or Health Data Research UK
Key exclusion criteria1. People under the age of 18
2. People without capacity to consent
3. People with insufficient written and verbal English language to complete consent and data collection
Date of first enrolment15/10/2025
Date of final enrolment30/11/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Aintree University Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Sponsor information

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/11/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to resource constraints

Editorial Notes

23/09/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).