Mental Health, Oral Health Care, Psychosis
Conditions
Keywords
Mouth Matters, Dentistry, mental health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLink work intervention
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.
Sponsors
Lancashire and South Cumbria NHS Foundation Trust
Greater Manchester Mental Health NHS Foundation Trust
Pennine Care NHS Foundation Trust
Northumberland, Tyne and Wear NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
Lancaster University
University of Liverpool
University of Leeds
University of Manchester
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants undertaking clinical assessments will be blind to the treatment allocation. The investigators will monitor and record all breaking of the blind on a structured form. The co-investigator team, TSC and DMC will review blind breaks to establish and implement learning and reduce further blind breaks. Where possible, when one researcher becomes unblinded, a second unblinded researcher will complete the assessment. Deliberate unblinding of the researchers during the trial is unlikely, but will be considered by the senior management team and could occur in cases of risk or safeguarding. Statisticians will be masked to randomisation outcome until finalisation of the statistical analysis plan to avoid bias.
Intervention model description
The link work intervention consists of six-sessions with a trained link worker over nine-months. The link worker will provide emotional and practical support to support the person to access a routine dental appointment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years. * Receipt of care from community mental health or early intervention teams at the point of referral. * No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part. * Able to provide informed consent as determined by trained researchers in consultation with the clinical team.
Exclusion criteria
* Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community. * Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible. * Enrolled in another dental randomised controlled trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at a planned care appointments | From baseline to nine-month follow-up assessment. | As measured by the National Health Services Business Services Authority (NHS BSA). |
| Oral health related quality of life | From baseline to nine-month follow-up assessment . | Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported attendance at a planned dental appointment. | From baseline to nine-month follow-up assessment. | Self-report dental attendance items. |
| Orofacial pain & disability | From baseline to nine-month follow-up assessment | 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). |
| Confidence around dental visiting | From baseline to nine-month follow-up assessment. | Single item of self-efficacy around attendance. Range 1-7. A higher score indicates greater confidence around dental visiting. |
| Self-esteem | From baseline to nine-month follow-up assessment | Rosenberg Self-Esteem Scale. Range: 0-30. A higher score indicates better self-esteem. |
| Dental anxiety | From baseline to nine-month follow-up assessment. | Modified Dental Anxiety Scale. Range: 5-25. A higher score indicates greater levels of dental anxiety. |
| General anxiety | From baseline to nine-month follow-up assessment . | Generalised Anxiety Disorder Questionnaire. Range: 0-21. A higher score indicates greater levels of anxiety. |
| Depression | From baseline to nine-month follow-up assessment. | Patient Health Questionnaire - 9 items. Range 0-27. A higher score indicates greater levels of depression. |
| The number of planned dental appointments attended | From baseline to nine-month follow-up assessment. | Recorded via the National Health Service Business Services Authority. |
| Self-reported access to free/subsidised dental care. | From baseline to nine-month follow-up assessment. | Self-report items |
| Exemption status for dental care | From baseline to nine-month follow-up assessment. | As recorded by the National Health Service Business Services Authority |
| Completion of a course of dental treatment | From baseline to nine-month follow-up assessment. | As record via the National Health Service Business Services Authority. |
| Self-reported utilisation of urgent or emergency dental services. | From baseline to nine-month follow-up assessment. | Self-report items |
| Quality adjusted life years | From baseline to nine-month follow-up assessment. | 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. |
| Utilization of healthcare resources | From baseline to nine-month follow-up | Co-designed health economics questionnaire recording utilisation of services and treatment. |
Countries
United Kingdom
Contacts
CONTACTDr Palmier-Claus, PhD, DClinPsy
Outcome results
None listed