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Neurofibromatosis Type 1 (NF1)NCT07818213

How Can the Experience of Hospital Outpatient Departments be Improved?

An observational study of Neurofibromatosis Type 1 (NF1) and NF2-related Schwannomatosis, run by King's College London at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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Trial summary

This project aims to improve outpatient departments by working with patients and staff to make these spaces more inclusive for people with sensory challenges (it focuses on people with nerve tumour conditions as they are more likely to have sensory challenges). Read more about this study

Who is it for?
Ages 16 to 99 yearsHealthy volunteers can take part
What is being tested?
Qualitative data collection activities
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
1 Sep 2026to 1 Jun 2029
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Participants will be recruited from the Neurofibromatosis Department at Guy's Hospital, part of Guy's and St Thomas' NHS Foundation Trust, a nationally commissioned centre for NF1 and NF2.

Who may be able to join

  • Patients aged 16 or over who attend outpatient appointments coordinated by the Guy's and St Thomas' NHS Foundation Trust NF team
  • Patients who identify as having sensory challenges
  • Carers and relatives accompanying patients
  • Staff providing care for people with nerve tumour predisposition conditions at Guy's and St Thomas' NHS Foundation Trust in any job role or banding.

Who cannot join

  • Individuals who are unable to provide explicit informed consent.
  • Paediatric patients under 16 years of age.
  • Temporary staff who have spent less than one shift in their role.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rona Inniss, MSc, RN contact

+44 207 1889976

rona.inniss@nhs.net

Sue Woodward, PhD contact

+44 207 8483469

Sue.woodward@kcl.ac.uk

United Kingdom1 site
  • Guy's and St Thomas' NHS Foundation Trust

    London, London, SE1 9RT

    Rona Inniss, Msc, RN, +44 207 1889976, rona.inniss@nhs.net

    Rona Inniss, MSc, RN

Other trials in United Kingdom

About this study

Official title: How Can the Experience of Hospital Outpatient Departments for Neurofibromatosis (NF) Patients With Sensory Challenges be Improved? An Experience Based Co-Design Project.

This project aims to improve outpatient departments by working with patients and staff to make these spaces more inclusive for people with sensory challenges (it focuses on people with nerve tumour conditions as they are more likely to have sensory challenges). The project uses a well-established method called experience-based co-design (EBCD), which supports patients and staff to work together. It will run over 4 years.

Read the detailed description

Participant experience overview:

People can choose to take part in one or more parts of this study. Some patients, carers and staff may be observed in outpatient waiting areas to help the researcher understand how the department works, and anyone who does not wish to be observed can let staff know and will not be included. Patients may be invited to take part in a one-off walking interview during their normal route to an outpatient appointment, and staff may be invited to take part in a single group discussion. Patients and staff who wish to be more involved can also choose to attend workshops over time to identify problems and work together to design improvements. Taking part in later stages is optional, consent is checked at each stage, sessions are audio recorded, and participants can stop at any time without giving a reason.

Data will be collected via Experience Based Co-Design (EBCD) stages. EBCD combines ethnographic methods and participatory quality improvement approaches to generate meaningful, co-designed interventions through iterative stages. Individual participants will be able to join as many stages as they would like and will be reconsented for each stage.

Stage 1: Observations using ethnographic methods: context setting via researcher field notes exploring and understanding patient, carers and staff experiences of outpatients departments.

The researcher will conduct 30 hours of shadowing, static observation and interviews of/with staff, patients and carers in outpatient waiting rooms.

Staff will be given information about the observations in department meetings, weekly improvement huddles, and at the department patient and staff forum. Staff will be reminded that observations are taking place in daily huddles. Patients and carers will be informed via posters and leaflets and notified by the department receptionist that a researcher is present and observing activity. Any people who explicitly opt out will not be observed. Only relevant data will be collected, and consent will be gained for any significant interaction or observation but for ethnographic observations, may not be considered formal research participants and it may not be possible to gain consent from each individual observed (i.e. people incidentally present). Ethnographic field notes will be translated into ethnographic transcripts and data will be analysed.

Stage 2 (a): Staff focus groups: exploring the experiences and perceptions of outpatient staff supporting patients with sensory challenges in small face-to-face or virtual groups.

Up to 12 participants (staff working in the NF and other relevant outpatient departments at Guy's and St Thomas' NHS Foundation Trust) will be invited to take part in a small focus group. The discussions will be directed by topic guides developed from the data gathered via observations (i.e. stage 1) and subsequent discussion with the PPI group, steering group and PhD supervisors. The focus groups will last up to 90 minutes and will be recorded with a Dictaphone. Audio data will be transcribed and analysed.

The participants will be offered a voucher to thank them for their time for activities outside work hours. They will be invited to take part in later stages (co-design meetings, improvement groups and the celebration event).

Stage 2 (b): Walking interviews: exploring the experiences, perceptions and descriptions of barriers for patients with sensory challenges and their families through point-of-view filmed walking-interviews.

Up to 18 participants (patients using the NF department at Guy's and St Thomas' NHS Foundation Trust) will be invited to take part in walking interviews. Walking interviews are 1:1 interviews that take place as the researcher and participant walk together. Although they are called walking interviews, the form of transit will be the usual form used and appropriate to the participant (i.e. via foot, wheelchair, mobility scooter, stretcher, etc.) and with or without carers and family as usual and comfortable. The interviews will be coordinated with existing appointments, and the participants will meet the researcher at the hospital entrance before walking their usual route to their appointment with the researcher. The researcher will obtain full informed consent from the participant in advance but on the day of the interview, before starting, the researcher will briefly explain how the walk will go and what will be discussed. After the interview, the researcher will invite the participant for a short discussion to add details and to check in. The interview will take less than 30 minutes (as long as the usual walk to their appointment).

The researcher will wear a mountable video camera to record the walk, and a Dictaphone will record the discussion. The video will be sent to a video editor to obscure the identities of any people incidentally recorded and to be edited together with other patients' walking interviews. The videos will be used by patients and staff in the later stages to provoke discussion. The audio data will be transcribed and analysed.

The participants will be offered a voucher to thank them for their time. They will be invited to take part in later stages, but participation is optional rather than expected (co-design meetings, improvement groups and the celebration event).

Stage 3: Co-design meetings: establishing priorities for improvement of outpatient departments for patients with sensory challenges through audio recorded patient and staff workshops.

Up to 12 participants (patients and staff) will be invited to explore collective responses to the video developed from the walking interviews in stage 2b. Using a topic guide and arts-based tools such as sketching, collaging and annotating photos and maps, participants will establish improvement priorities through up to three co-design meetings each lasting up to 45 minutes. The meetings will be held either face-to-face or remotely to accommodate participants as much as possible and the groups will be comprise of 4 to 8 participants (patients, staff and patients and staff working together). Response to the video and topic guides developed from data gathered in stage 1 and 2 and from discussion with the PPI group, steering group and PhD supervisors will form a loose frame for the discussion. Audio data will be recorded with a Dictaphone/ via the remote platform and transcribed and analysed.

The participants will be offered a voucher to thank them for their time (including staff when activities fall outside work hours). They will be invited to take part in later stages, (improvement groups and the celebration event), but participation is optional rather than expected.

Stage 4: Improvement working groups: co-designing and developing an intervention to support improvement of outpatient departments for patients with sensory challenges via small audio recorded working groups of patients, carers and staff.

Up to 12 participants (patients and staff) will be invited to take part improvement working groups co-designing an intervention responding to priorities identified in stage 3 co-design meetings. Using a topic guide and arts-based tools such as sketching, collaging and annotating photos and maps, participants will design interventions through six to eight co-design meetings each lasting up to 45 minutes. It is hoped participants will take part in all six to eight meetings in this stage. The meetings will be held either face-to-face or remotely to accommodate participants as much as possible. As with the co-design meetings, the groups will be a mix of staff and patients. Topic guides developed from data gathered in stages 1, 2 and 3 and discussion with the PPI group, steering group and supervisors will support discussion but it will primarily be led by priorities identified in the previous co-design groups (stage 3). Discussion will be recorded with a Dictaphone. or via the remote platform and the audio data will be transcribed and analysed.

The participants will be offered a voucher to thank them for their time (including staff when activities fall outside work hours). They will be invited to join the celebration event, but participation is optional rather than expected.

Review, feedback and dissemination: An event will be held to review the project, to thank participants, and to communicate outcomes to participants, the wider team, and to stakeholders. The event specifics will be agreed through the process.

Being tested
Qualitative data collection activities
Keywords
Neurofibromatosis, NF, sensory challenges, Experience Based Co-Design, outpatient departments, visual impairment, hearing impairment, learning differences, behavioural differences
Medical subject headings
Neurofibromatosis 1, Neurofibromatoses, Vision Disorders, Hearing Loss, Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qualitative data collection activitiesBehavioural

    Participants will take part in qualitative data collection activities including ethnographic observations, walking interviews, focus groups and co-design workshops. These activities are used to explore experiences of outpatient departments and collaboratively identify priorities for improvement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Qualitative themes describing patient, carer and staff experiences of outpatient departments (identified through qualitative thematic analysis of interview, observation and workshop data)

    Interview transcripts, ethnographic field notes, walking-interview recordings, focus group and co-design workshop discussions will be analysed using qualitative thematic analysis to generate themes describing patient, carer and staff experiences of outpatient departments. These themes will include barriers and facilitators to accessing outpatient environments, priorities for improvement, and co-designed solutions.

    Measured: From enrolment through completion of all EBCD qualitative co-design activities, up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07818213
Sponsor's protocol ID
364737
Other IDs
NIHR306421
Status last verified
Apr 2026
First submitted
3 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because participants have not provided consent for their personal data to be shared outside the research team, and ethical approval does not permit wider data release. The study involves qualitative material that cannot be fully anonymised without compromising confidentiality. Summary findings will be shared publicly.

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