The Mouth Matters in Mental Health Trial -2

Official title

A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial

Overview

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

• Behavioral Link 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 r

Primary outcome measures

• Attendance at a planned care appointments [Time frame: From baseline to nine-month follow-up assessment.]
• Oral health related quality of life [Time frame: From baseline to nine-month follow-up assessment .]

Secondary outcome measures (12)

• Self-reported attendance at a planned dental appointment. [Time frame: From baseline to nine-month follow-up assessment.]
• Orofacial pain & disability [Time frame: From baseline to nine-month follow-up assessment]
• Confidence around dental visiting [Time frame: From baseline to nine-month follow-up assessment.]
• Self-esteem [Time frame: From baseline to nine-month follow-up assessment]
• Dental anxiety [Time frame: From baseline to nine-month follow-up assessment.]
• General anxiety [Time frame: From baseline to nine-month follow-up assessment .]
• Depression [Time frame: From baseline to nine-month follow-up assessment.]
• The number of planned dental appointments attended [Time frame: From baseline to nine-month follow-up assessment.]
• Self-reported access to free/subsidised dental care. [Time frame: From baseline to nine-month follow-up assessment.]
• Exemption status for dental care [Time frame: From baseline to nine-month follow-up assessment.]
• Completion of a course of dental treatment [Time frame: From baseline to nine-month follow-up assessment.]
• Self-reported utilisation of urgent or emergency dental services. [Time frame: From baseline to nine-month follow-up assessment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 5 centers

• Lancashire & South Cumbria NHS Foundation Trust — Preston
• Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust — Newcastle upon Tyne
• Pennine Care NHS Foundation Trust — Ashton-under-Lyne
• South London and Maudsley NHS Foundation Trust — London
• Greater Manchester Mental Health NHS Foundation Trust — Manchester

Identifiers

NCT: NCT07470437 · NIHR171340 · 350197

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗