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Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care
Ryan Charles Kelly1, Peter Phiri2, Hermione Price2
1Spotlight Consultations Ltd, Portsmouth, UK. ryan@spotlightaq.co.uk.
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 HbA1c 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.
Insights
This study investigates a new pre-clinic assessment to improve diabetes management by enhancing patient-professional communication. The goal is to improve health outcomes for individuals with diabetes through better consultation practices.
Area of Science:
- Medical Research
- Clinical Trials
- Diabetes Management
Background:
- Despite numerous diabetes treatments, <25% of adults achieve glycemic targets.
- Patient behavior and clinical support are crucial but often lacking in current healthcare models.
- Existing interventions are insufficient for optimal diabetes health outcomes.
Purpose of the Study:
- To evaluate a pre-clinic assessment intervention aimed at improving patient-professional communication in diabetes care.
- To assess the impact of enhanced consultation duration on diabetes management and patient outcomes.
- To determine the clinical and cost-effectiveness of a novel intervention for diabetes care.
Main Methods:
- A multi-center, randomized trial (Spotlight-AQ study) involving 200 adults with type 1, type 2, or pre-diabetes.
- Comparison of a pre-clinic assessment intervention with usual care in routine outpatient appointments.
- Intervention delivered within one week prior to scheduled appointments.
Main Results:
- The study will analyze primary outcomes including consultation duration.
- Secondary outcomes encompass functional health status, diabetes distress, depression, treatment satisfaction, self-care behaviors, and glycemic control (HbA1c).
- Cost-effectiveness and impact on healthcare professionals (burnout, satisfaction) will also be evaluated.
Conclusions:
- Results will inform improvements in patient-professional communication within diabetes care.
- If effective and cost-efficient, the intervention could enhance communication and health outcomes.
- Findings will be disseminated to clinicians and researchers in the diabetes field.
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