Spotlight Tools to Improve Routine Clinical Care
Research type
Research Study
Full title
Spotlight Consultations: Efficacy and Cost-effectiveness for Use In Routine Care with People with Type 1, Type 2 Diabetes or Pre-Diabetes
IRAS ID
289964
Contact name
Katharine Barnard-Kelly
Contact email
Sponsor organisation
Southern Health NHS Foundation Trust
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
"Research Summary"
Aim & Method: To determine clinical and cost-effectiveness of the Spotlight Consultations tools via multi-centre RCT in routine primary or secondary care clinic appointments between healthcare professionals and adults with type 1 diabetes, type 2 diabetes or pre-diabetesPopulation: Adults with type 1 diabetes, type 2 diabetes or pre-diabetes
Intervention: Spotlight Consultations tools
Comparator: Usual Care
Outcomes: Primary: Consultation duration time. Secondary: HbA1c, diabetes distress, treatment satisfaction, functional health status, depression and anxiety, weight, acceptability, usability, HCP burnout, cost-effectiveness and perceived impact for patients and healthcare professionals.
Time: Twelve-months of routine clinic list outpatient appointments per arm, to take account of variability in routine care delivery across centresSpecific Aims
SA1: Consultation Time: we hypothesize that Spotlight Consultations digital health tools will reduce consultation times, making them more focused and effective.
SA2: Clinical Effects of Spotlight Consultations: we hypothesize that Spotlight will improve key parameters of glucose control–haemoglobin A1c. Specifically: (i) A1c will be lowered (primary outcome), particularly for those with sub-optimal glycaemic control at baseline (A1c>7.5%); (ii) time in target range measured by CGM will concomitantly increase and (iii) diabetes distress will be reduced (key secondary outcome in SA2).
SA3: Psychosocial Effects of Spotlight Consultations: measured by a bank of patient-reported outcome measures. Psychosocial functioning is associated with patterns of poor lifestyle-related health behaviours, suboptimal glycaemic control, high glucose variability, and elevated risks for hypo- and hyperglycaemia. Individual expectations and experience, as well as factors driving treatment choice, determine further the degree of distress. Improving communication and encouraging intrinsic decision-making in goal-focused collaborative clinic visits with HCP will reduce distress and improve psychological health outcomes.
SA3: Relative Effectiveness of Spotlight Consultations: Assessment of Fidelity: Spotlight will offer personalized support to increase therapy acceptance, reduce therapy associated anxiety. Providing a clear understanding of pre-diabetes and diabetes-related priorities and preferred choice of care pathways of participants will reduce the burden on HCPs and decrease misunderstanding, mistrust or conflict in clinic visits. Intervention Fidelity will be compared to usual care to assess whether it leads to the same or different health benefits and psychological outcomes mixed-methods to determine acceptability, usability and experience of participation and impact on diabetes management and psychosocial functioning.
SA4: Cost-effectiveness: health economics analyses will assess cost-effectiveness of the intervention in routine care.
"Summary of results"
Background: Existing therapeutic interventions are well known, yet 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 addressing physical and mental health within routine consultations across healthcare settings.
Methods: A multi-centre, parallel group, individually randomised trial comparing consultation duration in adults diagnosed with T1D or T2D for ≥6 months to the Spotlight-AQ platform compared to usual care. The primary outcome was consultation length, with secondary outcomes of: HbA1c depression, diabetes distress, anxiety, functional health status and HCP burnout. Machine learning models were utilized to analyse 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 0.5-4.1 mins (3-14%) versus no change in the control group (-0.9 - +1.28 mins). HbA1c improved in the intervention group by 6mmol/mol (range 0-30) versus control group 3mmol/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 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 healthcare settings for improved outcomes.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0451
Date of REC Opinion
14 Dec 2020
REC opinion
Unfavourable Opinion