RAPIER: Can a new hearing referral pathway reduce the time taken to diagnose and treat hearing problems in military personnel?
| ISRCTN | ISRCTN62534664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62534664 |
| IRAS number | 272239 |
| Secondary identifying numbers | CPMS 43759, IRAS 272239 |
- Submission date
- 03/02/2020
- Registration date
- 14/02/2020
- Last edited
- 12/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
This study is exploring the potential for a change in the way that hearing healthcare is provided for people who work in the military. Due to their jobs, Armed Forces personnel are at much higher risk of hearing injury than the general public and therefore have more frequent tests of their ears and hearing as part of their work. This research will compare how long it takes for patients who have a hearing problem picked up on their routine hearing test to be reviewed, diagnosed and treated through the current pathway or through a new pathway.
Who can participate?
Adults working in the Armed Forces
What does the study involve?
The new pathway will use pictures/video taken of the ears with an automated hearing test performed with a boothless headset, meaning that a soundproof booth is not needed, and complete a questionnaire on a tablet computer. In order to do this people who are due for their routine hearing test will be offered the chance to join the study, if they chose to join they will be randomly allocated to either have their routine test or their routine test plus the new tests as well. The results of the hearing test and pictures will be sent securely to the Queen Elizabeth Hospital Birmingham where they will be reviewed by a team of specialists. The results will be returned electronically to the patient and GP. If a problem is found the patient will be offered an appointment in an optimised clinic the following week with the aim of requiring only a single visit.
What are the possible benefits and risks of participating?
There are minimal risks as all tests are non-invasive and painless. There is also no immediate direct benefit to study participants. Patients in the new model arm may receive their diagnosis and management plan more quickly.
Where is the study run from?
Queen Elizabeth Hospital, Birmingham (UK)
When is the study starting and how long is it expected to run for?
April 2018 to June2024
Who is funding the study?
The Ministry of Defence (UK)
Who is the main contact?
Christopher Coulson, Christopher.coulson@uhb.nhs.uk
Contact information
Principal Investigator
Office 2
4th Floor
Institute of Translational Medicine
Heritage Building
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
| Phone | +44 (0)121 371 8007 |
|---|---|
| Christopher.coulson@uhb.nhs.uk |
Study information
| Study design | Randomized; Interventional; Design type: Screening, Diagnosis, Prevention, Device, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Remote Audiometric Performance Innovation Evaluation and Review (RAPIER) study |
| Study acronym | RAPIER |
| Study objectives | This study is exploring the potential for a change in the way that hearing healthcare is provided for people that work in the military. Due to their jobs Armed Forces personnel are at much higher risk of hearing injury than the general public and therefore have more frequent tests of their ears and hearing as part of their work. We will compare how long it takes for patients that have a hearing problem picked up on their routine hearing test to be reviewed, diagnosed and treated through the current pathway or through a new pathway. The new pathway will use pictures/video taken of the ears with an automated hearing test performed with a boothless headset, meaning that a soundproof booth is not needed, and complete a questionnaire on a tablet computer. In order to do this people that are due for their routine hearing test will be offered the chance to join the study, if they chose to join they will be randomly allocated to either have their routine test or their routine test plus the new tests as well. The results of the hearing test and pictures will be sent securely to the Queen Elizabeth Hospital Birmingham where they will be reviewed by a team of specialists. The results will be returned electronically to the patient and GP. If a problem is found the patient will be offered an appoint in an optimised clinic the following week with the aim of requiring only a single visit. |
| Ethics approval(s) | Approved 21/02/2020, MOD Research Ethics Committee (MODREC Secretariat, Bldg 005, G02 Dstl Porton Down, Salisbury, Wiltshire, SP4 0JQ, UK; +44 (0)1980 956351; MODREC@dstl.gov.uk), ref: 996/MoDREC/2020 |
| Health condition(s) or problem(s) studied | Hearing injury |
| Intervention | The population will solely include Defence personnel presenting to primary care for routine occupational hearing screening or due to self-reported problems with their hearing. The population will be drawn from four fixed locations, one of which will be Reservists, and one special forces. Intervention: New model of hearing assessment with automated hearing testing, tympanometry, pictures/video of ear drums and structured history questionnaire. Comparison: Currently occupational hearing screening and secondary care referral system. Outcomes: Time from presentation to diagnosis and management, proportion of referrals that can be managed remotely (for both routine screening and acute presentations). Measurement of time required to assess and manage referrals via this model to predict resource implications. This observational study will be run concurrently in four military locations remote to University Hospitals Birmingham. The use of multiple physical locations will increase the number of potential participants in the study, allow qualitative feedback to be collected from a larger number of clinicians and provide a more generalised estimate of effect size than a single location which may have a non-standard population. Service personnel due for routine hearing screening as part of their occupational health programme or presenting complaining of problems with their hearing will be offered the opportunity to join the study. If they consent they will be randomised to either the current hearing referral model or to have their routine assessment plus screening through the RAPIER service. Results will be securely linked back to UHB for review at the military hearing MDT. Following the weekly MDT diagnosis and treatment plan information will be returned to the unit medical officer via the same system. Comparison will be made between pure tone audiometry obtained in their base and audiometric results captured by the RAPEIR service. Test Measures In addition to their routine screening protocol participants will receive: Pure Tone Audiometry, tympanometry and endoscopic examination. Unaided thresholds will be obtained via the Wireless Automated Hearing Test System (WAHTS) using pure tones up to 8kHz, tympanometry and i-endoscopic examination. Participant’s questionnaires A standardised history proforma will be used covering details of: age, previous noise exposure, previous ear problems/surgery, otological symptoms such as pain, discharge, tinnitus or balance problems as well as any previous hearing investigations. All of these tests are non-invasive and non-painful. Completing the additional tests will take less than 30 minutes and each subject will only complete the test battery once within the study period. The test will be completed in the following order: a) history via structured proforma b) video examination of the ears c) automated hearing test d) tympanometery (pressure testing). This is the most practicable order as this allows a patient to compete the history proforma without the attention of the medical officer or medic prior to clinical examination. Of the clinical tests the ears need to be inspected first to ensure the canals are not blocked with wax (which would falsely alter the results of the other tests) and tympanometry is an objective measure which does not require a patient’s active participation so should be performed after the subjective pure tone audiogram. Data Analysis Data will be collected on the time taken from screening abnormality to definitive diagnosis, the duration of time held on a temporary grading (if any) and the proportion of referrals that can be dealt with entirely remotely. The distributions of the times within each group will be assessed by visual inspection of Normal Q-Q plots and an independent samples t test will be used for the comparison of the two groups if the data for both groups appear to be approximately Normally distributed and a Mann-Whitney test will be used if they do not.Data will be compared to existing audit data on the Military Hearing Referral Pathway. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Time from presentation to diagnosis and management 2. Proportion of referrals that can be managed remotely (for both routine screening and acute presentations) 3. Time required to assess and manage referrals via this model to predict resource implications The methods of measurement of these outcome measures cannot be disclosed at this time. |
| Secondary outcome measures | - |
| Overall study start date | 01/04/2018 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1200; UK Sample Size: 1200 |
| Key inclusion criteria | 1. Armed Forces personnel aged over 18 years 2. Written and spoken English of sufficient standard to complete hearing history on a tablet computer |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Sponsor information
Hospital/treatment centre
HQ Joint Medical Group
Research & Clinical Innovation
Royal Centre for Defence Medicine
ICT Centre
97 Vincent Drive
Edgbaston
Birmingham
B15 2SQ
England
United Kingdom
| Philip.Woodgate100@mod.gov.uk | |
| Website | http://www.uhb.nhs.uk/ |
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- MOD
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study cannot be disclosed at this time. |
Editorial Notes
12/12/2023: The following changes have been made:
1. The overall study end date has been changed from 31/12/2023 to 30/06/2024 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/07/2024 to 31/01/2025.
11/12/2023: The recruitment end date has been changed from 31/12/2023 to 30/04/2024.
04/07/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2021 to 31/12/2023.
2. The overall study end date was changed from 30/04/2023 to 31/12/2023.
3. The intention to publish date was changed from 01/09/2023 to 31/07/2024.
4. Contact details updated.
04/04/2022: The following changes were made to the trial record:
1. The public contact was changed.
2. The overall end date was changed from 31/08/2021 to 30/04/2023.
3. The intention to publish date was changed from 30/04/2022 to 01/09/2023.
4. The plain English summary was updated to reflect these changes.
06/04/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2021 to 31/08/2021.
2. The plain English summary was updated to reflect these changes.
06/01/2021: The recruitment end date has been changed from 31/01/2021 to 31/08/2021.
27/07/2020: The ethics approval was added.
03/02/2020: Trial's existence confirmed by the National Institute for Health Research (NIHR).
