The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children.

BACKGROUND: Globally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care. METHODS: This 4-year randomised controlled trial will involve 600 children (aged 9-16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model. DISCUSSION: Treating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group. TRIAL REGISTRATION: This clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Funding and policy incentives to encourage implementation of point-of-care C-reactive protein testing for lower respiratory tract infection in NHS primary care: a mixed-methods evaluation.

OBJECTIVES: Utilisation of point-of-care C-reactive protein testing for lower respiratory tract infection has been limited in UK primary care, with costs and funding suggested as important barriers. We aimed to use existing National Health Service funding and policy mechanisms to alleviate these barriers and engage with clinicians and healthcare commissioners to encourage implementation. DESIGN: A mixed-methods study design was adopted, including a qualitative survey to identify clinicians' and commissioners' perceived benefits, barriers and enablers post-implementation, and quantitative analysis of results from a real-world implementation study. INTERVENTIONS: We developed a funding specification to underpin local reimbursement of general practices for test delivery based on an item of service payment. We also created training and administrative materials to facilitate implementation by reducing organisational burden. The implementation study provided intervention sites with a testing device and supplies, training and practical assistance. RESULTS: Despite engagement with several groups, implementation and uptake of our funding specification were limited. Survey respondents confirmed costs and funding as important barriers in addition to physical and operational constraints and cited training and the value of a local champion as enablers. CONCLUSIONS: Although survey respondents highlighted the clinical benefits, funding remains a barrier to implementation in UK primary care and appears not to be alleviated by the existing financial incentives available to commissioners. The potential to meet incentive targets using lower cost methods, a lack of policy consistency or competing financial pressures and commissioning programmes may be important determinants of local priorities. An implementation champion could help to catalyse support and overcome operational barriers at the local level, but widespread implementation is likely to require national policy change. Successful implementation may reproduce antibiotic prescribing reductions observed in research studies.