The clinical and cost-effectiveness of the DESMOND-ID education programme for adults with intellectual disability and Type 2 Diabetes: Stage 1 QRI Study

Introduction The NIHR HTA programme has funded Project: NIHR131692 - The clinical and cost-effectiveness of the DESMOND-ID education programme for adults with intellectual disability and Type 2 Diabetes. It is very important that we demonstrate that we can recruit adults with both these conditions effectively and swiftly in order to demonstrate that we can meet deadlines to progress to a full RCT. We plan to use QRI methodology. The QuinteT Recruitment Intervention (QRI) seeks to optimise recruitment and informed consent in randomised controlled trials (RCTs) . The approach was developed by Prof Donovan (Bristol University) with whom we will collaborate. Background Stage 1 (Internal Pilot) will run for 11 months to assess recruitment rates and retention for the primary outcome at 6 months. It aims to recruit 108 adults with type 2 diabetes and ID and the protocol and paperwork for each site for these activities are included above. There are 3 countries and sites involved in the Internal Pilot Study: Northern Ireland (Northern HSC Trust), Scotland (Greater Glasgow and Clyde) and England (Leicestershire). The recruitment targets in the Pilot Study are 108 participants (36 each site: 18 intervention, 18 control/TAU) and it is vital that we reach the target if we are to proceed to the main RCT. As outlined in a previous section, on each site an opportunity to take part in this study will be offered to potential participants by the local gatekeepers (LD nurses, diabetes nurses and GPs), those who show an interest in this study will then be visited or called by the part-time RA (60% FTE) appointed to the study on each site and who will lead on recruiting participants from this point. As service delivery is not the same in each country it is envisaged that routes to recruitment, while broadly following the protocol, might be slightly different of each site, recruitment rates and issues might also vary. To promote timely, effective recruitment to this study Quintet Recruitment Intervention (QRI) methods drawing from the work of Donovan et al (2016) and Wade et al (2009) will be used. Method The QRI processes will comprise two parts that will run concurrently. 1.To understand the process of recruitment as it happens. 2.Develop a plan to address identified difficulties and increase informed consent. Part 1. Understanding the process of recruitment. The rate of recruitment per site will be monitored on a weekly basis, noting numbers of people approached and by whom, number successfully recruited, reasons for exclusion, those who were invited but declined (with reasons if possible) and protocol compliance. Weekly screening logs and overall rates of recruitment (Consort Flow Diagram) will be shared across sites and with LT, Trial manager, VC, AD and MT. The QRI processes will involve VC (QRI Lead), the PIs on each site (AD, Leicestershire, MT, Scotland), LT Chief investigator, the Project RAs x 3, the gatekeepers who control access to potential participants ie GPs, LD nurses, diabetes nurses, health facilitators, clinical research nurses and people with ID/diabetes and possibly their nominated carer. An additional part-time RA (FTE 60%) will be employed to undertake the QRI data gathering and analysis.