Delivering Biopsychosocial Health Care Within Routine Care: Spotlight-AQ Pivotal Multicenter Randomized Controlled Trial Results

Background: Annual national diabetes audit data consistently shows most people with diabetes do not consistently achieve blood glucose targets for optimal health, despite the large range of treatment options available. Aim: To explore the efficacy of a novel clinical intervention to address physical and mental health needs within routine diabetes consultations across health care settings. Methods: A multicenter, parallel group, individually randomized trial comparing consultation duration in adults diagnosed with T1D or T2D for ≥6 months using the Spotlight-AQ platform versus usual care. Secondary outcomes were HbA1c, depression, diabetes distress, anxiety, functional health status, and healthcare professional burnout. Machine learning models were utilized to analyze the data collected from the Spotlight-AQ platform to validate the reliability of question-concern association; as well as to identify key features that distinguish people with type 1 and type 2 diabetes, as well as important features that distinguish different levels of HbA1c. Results: n = 98 adults with T1D or T2D; any HbA1c and receiving any diabetes treatment participated ( n = 49 intervention). Consultation duration for intervention participants was reduced in intervention consultations by 0.5 to 4.1 minutes (3%-14%) versus no change in the control group (−0.9 to +1.28 minutes). HbA1c improved in the intervention group by 6 mmol/mol (range 0-30) versus control group 3 mmol/mol (range 0-8). Moderate improvements in psychosocial outcomes were seen in the intervention group for functional health status; reduced anxiety, depression, and diabetes distress and improved well-being. None were statistically significant. HCPs reported improved communication and greater focus on patient priorities in consultations. Artificial Intelligence examination highlighted therapy and psychological burden were most important in predicting HbA1c levels. The Natural Language Processing semantic analysis confirmed the mapping relationship between questions and their corresponding concerns. Machine learning model revealed type 1 and type 2 patients have different concerns regarding psychological burden and knowledge. Moreover, the machine learning model emphasized that individuals with varying levels of HbA1c exhibit diverse levels of psychological burden and therapy-related concerns. Conclusion: Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes. Results reflect the importance of a biopsychosocial approach to routine care visits. Spotlight-AQ is viable across health care settings for improved outcomes.