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The STARFISH Trial - A randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss - IRAS 1004878
Participating GP practices must refer patients into the following sites: The James Cook University Hospital Sunderland Royal Hospital, Freeman Hospital. GP practices will not be set up as PICs - they will be set up as referring sites only as referring a patient with sudden hearing loss to A&E / ENT is already a standard pathway. There will be no contractual/green light process.
Recruitment end date: November 2026
Aim: Hearing loss is a common and disabling condition that may result from problems with the cochlea, the inner ear structure that senses sound and sends information to the brain. Loss of hearing due to damage to the cochlea can occur suddenly and without an obvious cause,a condition described as sudden sensorineural hearing loss (SSNHL).
SSNHL can range from mild hearing loss to a completely deaf Ear, which can make it difficult to understand people talking on the affected side. Recovery of hearing following SSNHL may be helped by urgent treatment with steroids, but crucially we do not know if these work best given as tablets or by an injection through the ear drum. If SSNHL is identified more than a few weeks after it occurs,steroids may
have little effect.
A major problem is that patients with SSNHL may not be referred to Ear, Nose and Throat (ENT) surgeons in time to benefit from steroid treatment (within four weeks), due to delays in the hearing loss being recognised or referred by general practitioners (GPs). Sudden hearing loss is rare and we usually do not know why it happens. Steroids are the best treatment to try and improve the hearing, but we do not know whether it is best to give them by mouth or by an injection through the ear drum. These treatments are used regularly in the NHS and include:
1) Steroid tablets taken by mouth
2) Steroid injections
3) A combination of both the above
This trial aims to find out which of the different steroid treatments works best in improving the hearing of patients suffering from your type of hearing loss. The trial will take a group of patients and assign them randomly to one of the three treatment methods commonly used. We will then track their hearing recovery, as well as measuring the impact of the hearing loss on the participants’ lives with questionnaires.
Requirements:
Site set up, which includes installing pop-up to SystmOne or EMIS. During consultations, if the relevant codes for sudden hearing loss are inputted, the pop-up will appear advising the patient may benefit from referral to A&E/ENT for steroid treatment in accordance with NICE guidance. Following referral to A&E/ENT, any potential participants will be picked up by the Research Team located at the recruiting secondary care site, where they will be approached and screened for the STARFISH study.
Payments:
SSCs
£100.00 for site set up and installation of pop-up
£20.00 per participant recruited (study team will be informing us of participants that have been recruited and referred by referring GP practices)
Antidepressants to prevent relapse in depression in older people (ANTLER 75+ Trial) – a double blind randomised controlled trial to evaluate the effectiveness and cost-effectiveness of continuing antidepressants - IRAS 1009793
PIC Study for CNTW (there are no on-site visits so there are no geographical limitations to PIC participation)
Recruitment end date: December 2026
Aim: Continuation of antidepressant medication vs tapering and discontinuing antidepressant medication to estimate the effectiveness and cost-effectiveness in preventing depression relapse in people aged 75 and over.
Participants will be randomised into 2 groups: Arm A (continue with usual antidepressant) and Arm B (taper off and discontinue usual antidepressants)
Comparator (Arm A): Continued treatment with citalopram 20mg, sertraline 50mg or mirtazapine 30mg using identical appearing study IMP.
Intervention (Arm B): 12 months’ discontinuation after tapering in patients receiving treatment with citalopram 20mg, sertraline 50mg or mirtazapine 30mg. Using identical appearing tapering dose of antidepressants and placebos.
Requirements:
Search for eligible participants using pre built search
Screen the list and remove any patients who are unsuitable for the study
Mailoutvia Docmail
Liaise with CNTW re pausing/resuming patients’ prescriptions
Payments:
SSCs
£1.80 per patient - screen of patient list
£200 - Study setup (covers the cost of running the database search)
Research Costs:
£13.65 - Mailout via Docmail
Thyroid inflammation in Hashimoto thyroiditis (TRIUMPH) - IRAS 333533
PIC Study for Newcastle only
Recruitment end date: 30.11.2026
Aim: A randomised, double-blind trial recruiting 48 women with Hashimoto’s thyroiditis with persistent fatigue. Participants will be treated with mycophenolate mofetil (MMF) or placebo to determine proof-of-concept that improving chronic inflammation can help improve persistent symptoms. The primary outcome will be determined by changes in number of inflammatory thyroid lymphocytes, assayed by flow cytometry.
Requirements:
Search for eligible participants using pre built search
Screen the list and remove any patients who are unsuitable for the study
Text or mail out via Docmail
Coordinate with RRDN Agile team staff so participants can come into the practice for a blood test. This will be carried out by RRDN agile staff.
Payments:
SSC's
Preparation for Database search - £23.21
Database search - £23.21
Check Lists for Exclusions - £36 per 40 patients
RC's
local coordination and set up - £113.21
Text message batch - £6.65
mail out - £10.96 per 25 patients
The Parent and Baby Project - Preventing food allergy in infants with early tastes of common food allergens: feasibility and cluster randomised controlled trial - IRAS 351201
PIC Study for South Tees and Newcastle
Aim: The aim of the study is to test a new approach to allergy prevention in infants aged 0-3 months. Those randomised to intervention will introduce small traces of egg and peanut from 17-weeks. Those in the control arm will follow standard food introduction guidelines.
Requirements: Monthly for 6 months, practices will be required to run a prebuilt search in SystmOne or EMIS, screen, and send an approved text message to parents/guardians of potentially eligible infants. Practices can also opportunistically invite potentially eligible participants in vaccine clinics. Practices will also be required to carry out a medical notes review of recruited participants.
Payments:
Monthly database searches for 6 months: £141.00
Eligibility check for monthly mail-outs (15 mins per month for 6 months): £153.00
Site set-up training: £46.25
Text out (one per month for 6 months): £78.00
Medical notes reviews (2 hours of GP time): £194.00
Integrated Bipolar Parenting Intervention - IRAS: 309190
Recruitment end date: 31.01.2027
Aim: The study aims to support an underserved population by assessing whether providing parents who experience bipolar disorder with online parenting support leads to their children having fewer behavioural problems. This project will also investigate if this intervention helps parents feel less stressed and more confident about their parenting, and to experience fewer mood or anxiety problems.
Requirements: PICs will be expected to support recruitment by identifying potential participants, through database searches. PICs would then be expected to make contact with these potential participants by letter, email, or phone to inform them of the study. In so doing, it is expected that PICs would provide the potential participants with a description of the study, an overview of what participation involves, and a link to the trial’s online registration of interest form. PICs will not be expected to provide participant information sheets or to consent participants.
Payments:
Service Support Costs : Preparation for database search 1hr -practice manager = £23.21
Database search 1hr - practice manager = £23.21
Check lists for Exclusions - GP (10pts ) =£9.00
Smell Test Direct - IRAS 285735 CPMS 46245
PIC Study inviting patient on behalf of the research site Newcastle - Clinical Ageing Research Unit (Sites need to be within a 1.5 hour drive of CAV)
Recruitment end date: March 2026
Aim: The Smell Test Direct study aims to better understand the link between loss of smell and risk of brain disease. This study, run by The Michael J. Fox Foundation for Parkinson’s Research, is exploring this link by providing study participants with a simple scratch-and-sniff test that they can do from home.
Requirements: Run the prebuilt search and approve list of patients to be contacted
Payments: Practice will receive £7 per patient consented to the study from their practice.
UK-EDI IRAS 258093
UK-EDI IRAS 258093
PIC Study for QE Hospital Gateshead
Recruitment end date: 31.12.2025
Aim:This is an observational cohort study aimed at determining the feasibility of detecting pancreatic cancer in individuals over fifty years of age who are newly diagnosed with Diabetes Mellitus (DM).
Requirements: GP Practices will act as PICs to refer potential participants to Secondary Care. Practices will be asked to sign PIC agreement, import & run health record searches, install pop up, database search and eligibility screening and mailout via Docmail.
Payment:Service Support Costs
Initial database search - £13.48
Initial patient eligibility check - £40.00
Maximum of 6* follow up database searches - £36.74
Maximum of 6* follow up eligibility checks - £15.00
Total SSCs available £135.22
*6 additional searches/checks expected for practices participating over the whole 28 month recruitment period
Research Costs
GP training - £90.00
Nurse training - £26.96
Upload to Docmail - £13.48
Subsequent uploads to Docmail** - £15.00
Total research costs available £135.44
**6 additional Docmail uploads expected for practices participating over the whole 28 month recruitment period
ASCEnD - IRAS: 1007468
PIC study referring to The CAPE Clinic, Newcastle
Recruitment end date: 30/11/2025
Aim: ASCEnD is a pragmatic open label RCT in bipolar depression of quetiapine vs aripiprazole/sertraline combination
Requirements: Practice to act as a PIC site for CNTW - recruitment will take place at the CAPE clinic in Newcastle Centre
Run a pre built search
Screen the list of patients to exclude anyone who is not eligible
Text out to eligible patients
Payments:
Service Support:
● Database search - £21
● Screen lists for exclusions - £90 (per 50 patients)
● Opportunistic invite per participant approached:
GP - £4.50
Pharmacist - £2.75
Practice Nurse - £1.16
Research costs:
PIC local Coordination and set up - £113.21
Mail out using Docmail (per mail out) £13.29 or Sending of Text Message to inform patients of study (per text out) £6.65
Sterling PMR - IRAS: 1005826
PIC study referring to The James Cook University Hospital and Newcastle Hospitals
Recruitment end date: 31/01/2026
Aim: A non commercial study trying to find out whether adding a disease-modifying anti-rheumatic drug (DMARD) to steroid treatment helps people with polymyalgia rheumatica.
Requirements: Practice to act as a PIC site for the study site, The James Cook University Hospital and Newcastle Hospitals.
Run a pre built search
Screen the list of patients to exclude anyone who is not eligible
Mail out via Docmail to eligible patients
Payments:
Service Support:
Database search £21
Eligibility check (exclusions) £44
Add pop-up to GP system to identify patients opportunistically during appointments £4
Research costs:
Study specific training (reading through guidelines for conducting search and mail out) £121 one off payment
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