ClinicalTrials.gg
Not yet recruitingNCT07818213Updated Sep 14, 2026

How Can the Experience of Hospital Outpatient Departments be Improved?

An observational study in Neurofibromatosis Type 1 (NF1) and NF2-related Schwannomatosis, sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 16 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by King's College London · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
16 Years to 99 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Neurofibromatosis Type 1 (NF1)
  • NF2-related Schwannomatosis

Keywords

  • Neurofibromatosis
  • NF
  • sensory challenges
  • Experience Based Co-Design
  • outpatient departments
  • visual impairment
  • hearing impairment
  • learning differences
  • behavioural differences
03

In context

Neurofibromatosis 1

176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.

This study's planned enrollment of 30 is below the median of 188 across 58 observational studies indexed under Neurofibromatosis 1.

Browse Neurofibromatosis 1 studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are unable to provide explicit .
  • Paediatric patients under 16 years of age.
  • Temporary staff who have spent less than one shift in their role.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • BehavioralQualitative data collection activities

    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.

06

What researchers measure

Primary outcomes

  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.

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 14, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Jun 1, 2029
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07818213
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Rona Inniss, MSc, RN
Contact
rona.inniss@nhs.net
+44 207 1889976
Sue Woodward, PhD
Contact
Sue.woodward@kcl.ac.uk
+44 207 8483469
Sue Woodward, PhD
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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