Optimising the CARE Plus Trial

• Research type

  Research Study

• Full title

  Optimising the identification and selection of potential eligible patients for the definitive CARE Plus Randomised Controlled Trial

• IRAS ID

  231820

• Contact name

  Stewart Mercer

• Contact email

  stewart.mercer@glasgow.ac.uk

• Sponsor organisation

  NHS Greater Glasgow & Clyde

• Duration of Study in the UK

  0 years, 5 months, 27 days

• Research summary

  The CARE Plus intervention is a primary care-based complex intervention for people with multimorbidity. It was developed and tested in an exploratory randomised controlled trial, which showed that it was feasible in GP Practices serving socio-economically deprived population, and suggested it may be both clinically and cost-effective. An application for funding for a definitive trial was rejected by NIHR at the final stage earlier last year. The present study seeks to address the key issue raised by the reviewers -i.e. our proposed approach to identifying and selecting patients for the trial and its associated potential selection bias. Our proposed approach, based on the feasibility trial, was that GPs would identify and invite multimorbid patients that they deemed suitable for the intervention. The NIHR reviewers recommended a more systematic scientific approach.
  This study will design and conduct a number of different electronic searches of GP patient records in a small number of practices in Glasgow to ascertain if eligible patients can be identified by these means. The searches will include the use of disease registers; prescribing data; and data on frequency of attendance at the GP Practice, Out-of-Hours services, Accident & Emergency, and unplanned hospital admissions in the previous 12 months. The aim is to identify ‘high-burden, high cost’ multimorbid patients. We will then screen these patients by a postal questionnaire for self-reported health and quality of life (EQ-5D-5L), since the primary aim of CARE Plus is to improve quality of life. The cut-off levels for inclusion in terms of general health and quality of life will be based on the values we found in the feasibility work. In this way we will be able to determine whether or not electronic record searches will be likely to produce a cohort of patients suitable for the CARE Plus intervention.

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0302

• Date of REC Opinion

  15 Sep 2017

• REC opinion

  Favourable Opinion