This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life. The main predictions are that: 1. The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone. 2. The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone. 3. The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
Aim: To evaluate the effectiveness and cost-effectiveness of a link work intervention to facilitate dental attendance in people with severe mental illness. Methods: An effectiveness randomised-controlled trial with integrated cost-effectiveness analysis and process evaluation. 480 participants will be recruited from five NHS Trusts and randomised (ratio 1:1) to either treatment as usual or treatment as usual plus the link work intervention. The link work intervention will follow the manual co-developed and used in the feasibility trial. Blind research assistants will support participants to complete assessments at baseline and after nine-months. The investigators will obtain consent to access participant's dental visiting data via the Business Services Authority. The primary outcomes are i) attendance at a routine dental appointment, and ii) oral health related quality of life. Health economics analysis will assess whether the intervention is cost-effective. A qualitative process evaluation will help to understand how it works and might be implemented. Results/conclusions: This research hopes to produce the first evidenced-based intervention for improving the oral health of people with severe mental illness. It could help to overcome inequities in dental access.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
480
The mental health link work intervention uses link workers to empower and assist people with severe mental illness currently supported by secondary care mental health services, but not dental services, to access planned dental appointments. The link work intervention in the study proposal has the following dimensions: * Delivered by mental health support workers. * Focused on oral health as the primary health issue. * Setting is in secondary mental health care linking to dental care * Primary role is navigating or bridging services. * It builds motivation where needed and offers advocacy. * Its builds self-efficacy and recursively through social persuasion, positive reinforcement, and positive experiences of dental visits and interacting with dental services. * Training and supervision to link workers supports intervention delivery.
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, Northumberland, United Kingdom
Pennine Care NHS Foundation Trust
Ashton-under-Lyne, United Kingdom
South London and Maudsley NHS Foundation Trust
London, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, United Kingdom
Attendance at a planned care appointments
As measured by the National Health Services Business Services Authority (NHS BSA).
Time frame: From baseline to nine-month follow-up assessment.
Oral health related quality of life
Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life
Time frame: From baseline to nine-month follow-up assessment .
Self-reported attendance at a planned dental appointment.
Self-report dental attendance items.
Time frame: From baseline to nine-month follow-up assessment.
Orofacial pain & disability
Manchester Orofacial Pain Disability Scale. Two binary outcomes plus scale. Range: 0-52. Higher scores indicates greater pain (binary) / help seeking (binary) / pain related disability (scale).
Time frame: From baseline to nine-month follow-up assessment
Confidence around dental visiting
Single item of self-efficacy around attendance. Range 1-7. A higher score indicates greater confidence around dental visiting.
Time frame: From baseline to nine-month follow-up assessment.
Self-esteem
Rosenberg Self-Esteem Scale. Range: 0-30. A higher score indicates better self-esteem.
Time frame: From baseline to nine-month follow-up assessment
Dental anxiety
Modified Dental Anxiety Scale. Range: 5-25. A higher score indicates greater levels of dental anxiety.
Time frame: From baseline to nine-month follow-up assessment.
General anxiety
Generalised Anxiety Disorder Questionnaire. Range: 0-21. A higher score indicates greater levels of anxiety.
Time frame: From baseline to nine-month follow-up assessment .
Depression
Patient Health Questionnaire - 9 items. Range 0-27. A higher score indicates greater levels of depression.
Time frame: From baseline to nine-month follow-up assessment.
The number of planned dental appointments attended
Recorded via the National Health Service Business Services Authority.
Time frame: From baseline to nine-month follow-up assessment.
Self-reported access to free/subsidised dental care.
Self-report items
Time frame: From baseline to nine-month follow-up assessment.
Exemption status for dental care
As recorded by the National Health Service Business Services Authority
Time frame: From baseline to nine-month follow-up assessment.
Completion of a course of dental treatment
As record via the National Health Service Business Services Authority.
Time frame: From baseline to nine-month follow-up assessment.
Self-reported utilisation of urgent or emergency dental services.
Self-report items
Time frame: From baseline to nine-month follow-up assessment.
Quality adjusted life years
European Quality of Life five-dimensional questionnaire (EQ-5D-5L). Five health dimensions plus overall health score on a visual analogue scale range. Range on visual analogue scale: 0-100. A higher score indicates better health.
Time frame: From baseline to nine-month follow-up assessment.
Utilization of healthcare resources
Co-designed health economics questionnaire recording utilisation of services and treatment.
Time frame: From baseline to nine-month follow-up
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