Feasibility, acceptability and effectiveness of real time digital identification of clinical trial participants

Lead Supervisor
Dr Fiona Gaughran
Reader in Psychopharmacology and Physical Health
Dept of Psychosis Studies, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London

Professor Rob Stewart (King’s College London), Nabila Cruz (King’s College London)

Industrial Partner
South London and Maudsley NHS Foundation Trust

Project Details


This studentship is designed to assess the feasibility, acceptability and utility of a novel open clinical trials discovery platform to identify and alert patients, carers through staff in a mental health Trust to research projects which may be of interest to them.


The Care Quality Commission have recently included Research in their inspections, with the focus being on access to research options for all. But it is often difficult for staff to access the menu of suitable research options at the time of a patients appointment.  

Relatively speaking, research is embraced in physical health settings, with research offers in specialist services such as oncology, seen as a marker of quality. That perception is backed up by the evidence that people who participate in research projects experience better health outcomes (Downing et al, 2016; Ozdemir et al, 2015; Jonker & Fisher, 2018;  Boaz et al, 2015). However, the research culture arguably faces more challenges in mental health settings, with evidence of filtering by clinicians (Pinfold et al, (2019). Therefore current systems, which largely rely on staff providing the sole link between researcher and potential participant have limitations. 

The South London and Maudsley BRC has developed a Research participation register, Consent for Contact (C4C https://www.slam.nhs.uk/research/take-part-in-research/consent-for-contact) to which 17 thousand people have signed up. C4C allows researcher to search our Clinical Record Interactive Search (CRIS) (https://www.maudsleybrc.nihr.ac.uk/facilities/clinical-record-interactive-search-cris/)  for people who meet the inclusion and exclusion criteria for a given project and approach them directly. This gives the service user direct information regarding available projects.  However this system relies on people having signed up to C4C. Many service users have not yet done so, in particular, people entering the service for the first time. A parallel method for identifying people and informing them of their research options is needed, ideally in real time, in parallel with their clinical care.

The project will extend the University College London Hospitals NHS Foundation Trust (UCLH) FindaStudy platform, and build on the South London and Maudsley NHS Trust (SLaM) Consent for Contact system to create a system to alert clinicians in real time of research opportunities for their patients. 

The (UCLH) Findastudy platform uses structured clinical terminology to match available clinical trials to key words and diagnosed conditions in patient’s electronic medical records. SLaM Consent for Contact uses natural language processing to characterise the inclusion and exclusion criteria for portfolio studies and identify eligible patients; where patients have given their consent, they may then be identified and contacted directly outside of the clinical setting. 

This project will build on those two initiatives to annotate PJS and add descriptions of research project data to the Cogstack@Maudsley real-time platform in the Electronic Patient Journey System (EpJS) in the South London and Maudsley NHS Foundation Trust. Research project details will be taken from Edge (https://edgeclinical.com), a national clinical trial management system. Cogstack@Maudsley will then identify studies which the patient may be eligible for and, depending on research governance permissions, alert their clinician in real time. 


  1. To adapt CRIS C4C methodology for parallel use in Cogstack@Maudsley
  2. To run focus groups with staff, patients and carers to inform the development of alerting protocols using Cogstack@Maudsley
  3. To develop alerting protocols using Cogstack@Maudsley
  4. To determine and refine the sensitivity and specificity of the algorithms to identify potential research participants using inclusion and exclusion criteria through this system

To determine the feasibility and acceptability of introducing electronic health record based alerts that a given service user may find a particular project of interest.  


The first stage of the project (project A) will build upon the extensive C4C work (https://www.maudsleybrc.nihr.ac.uk/patients-public/take-part-in-our-research/consent-for-contact/) using the Clinical Record Interactive Search (CRIS). Applications to access CRIS and the analyses carried out using CRIS are closely reviewed, monitored and audited by a CRIS Oversight Committee, which carries representation from the Maudsley Caldicott Guardian and is chaired by a service user. The CRIS Oversight Committee is responsible for ensuring all research applications comply with ethical and legal guidelines.

Research project details will be taken from EDGE, a national clinical trial management system. All studies on the NIHR portfolio are listed on EDGE. 

Further governance will be through the governance committee of CogStack at Maudsley and will be informed by the Research Ethics Committee permissions for the individual projects.


Research, CogStack, C4C, EDGE