IPPACT phase 3: Observational Cohort Study - v1
Research type
Research Study
Full title
Improving prediction of psychosis in ARMS using a clinically useful prognostic tool (IPPACT) - Cohort Study
IRAS ID
272880
Contact name
Filippo Varese
Contact email
Sponsor organisation
Greater Manchester Mental Health NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Early Intervention in Psychosis Services (EIS) screen for people who may be at risk of developing psychosis (known as the ‘at risk mental state’ ARMS criteria) using a specialised interview – the Comprehensive Assessment of At Risk Mental States (CAARMS). However, not all those meeting ARMS criteria go on to develop psychosis, leading to potentially unnecessary treatment and distress. Therefore, we need to improve our ability to predict psychosis.
Clinical teams will routinely administer a battery of questions alongside the CAARMS to individuals in EIS. We will collect this information on a group of patients (those who do not opt out) and observe whether they transition to psychosis by 12 months. This will be our “observed” data. Once the study ends, we will compare the observed data with predictions from a novel psychosis prediction model (currently under development). Although the model will calculate a disease risk, this will be after the conclusion of the study. The model will therefore not be available for clinicians to support their decision making during the study, and study procedures will have no impact on clinical care.
After 12 month follow-up of the ARMS cohort, we will evaluate the model and report results in line with the best practice ‘Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD)’ guidelines. This will enable us to evaluate the predictive ability of the model.
We will also seek consent to follow up outcomes by accessing health records for up to 5 years, to enable assessment of long term predictive validity in future studies.
REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0037
Date of REC Opinion
18 Mar 2020
REC opinion
Further Information Favourable Opinion