Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes

BACKGROUND: Existing therapeutic interventions to treat diabetes are well known, yet the majority of people with diabetes do not consistently achieve blood glucose targets (even individual therapy targets) for optimal health, despite the large range of treatment options available. Such outcomes have remained stubbornly poor for decades with <25% adults with diabetes achieving glycaemic targets. Patient behaviour, individually supported in routine clinical care, is an important missing component to improved outcomes, in a medical healthcare model not ideally suited to supporting successful diabetes management. METHODS: A multi-centre, parallel group, individually randomised trial comparing consultation duration in adults with type 1, type 2 or pre-diabetes using the Spotlight Consultations pre-clinic assessment compared to usual care in the Spotlight-AQ study. Two hundred adults with type 1, type 2 or pre-diabetes attending routine care outpatient appointments across up to ten participating sites will be invited to participate. INTERVENTION: An outpatient pre-clinic intervention delivered within 1 week prior to scheduled routine outpatient appointment. PRIMARY OUTCOME MEASURE: Duration of routine outpatient consultation. SECONDARY OUTCOME MEASURES: Functional health status. Diabetes distress. Depression. Treatment satisfaction. Impact on self-care behaviours. HCP burnout. HCP treatment satisfaction and burden. Hypoglycaemia (time less than 70mg/dL). Hyperglycaemia (time above 180 mg/dL). Change in weight. Change in HbA(1c.) Cost effectiveness of intervention. DISCUSSION: Results from the study will provide valuable insights into patient-professional communication practices within routine care and recommendations will be made, as necessary, for improvements to that. If the intervention is shown to be clinically and cost-effective, the feedback from participants and healthcare professionals will be used to make any improvements prior to its deployment to support improved communication and associated health outcomes. ETHICS AND DISSEMINATION: The trial was approved by the Wales REC7 Research Ethics Committee (21/WA/0020). Results will be disseminated through national and international conferences, scientific journals, newsletters, magazines and social media. Target audiences include consultants and other clinicians in diabetes, and medical professionals or scientists overall. TRIAL REGISTRATION: ISRCTN15511689. Registered on 10 November 2021