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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 480
- 试验地点
- 7
- 主要终点
- Attendance at a planned care appointments
研究概览
简要总结
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:
- 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.
- The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone.
- The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment as usual plus a link work intervention
Participants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment.
干预措施: Link work intervention (Behavioral)
Treatment as usual
Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. The investigators will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm.
结局指标
主要结局
Attendance at a planned care appointments
时间窗: 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
时间窗: 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
次要结局
- Self-reported utilisation of urgent or emergency dental services.(From baseline to nine-month follow-up assessment.)
- Exemption status for dental care(From baseline to nine-month follow-up assessment.)
- Completion of a course of dental treatment(From baseline to nine-month follow-up assessment.)
- Orofacial pain & disability(From baseline to nine-month follow-up assessment)
- Confidence around dental visiting(From baseline to nine-month follow-up assessment.)
- Self-esteem(From baseline to nine-month follow-up assessment)
- Dental anxiety(From baseline to nine-month follow-up assessment.)
- General anxiety(From baseline to nine-month follow-up assessment .)
- Depression(From baseline to nine-month follow-up assessment.)
- Self-reported attendance at a planned dental appointment.(From baseline to nine-month follow-up assessment.)
- Self-reported access to free/subsidised dental care.(From baseline to nine-month follow-up assessment.)
- The number of planned dental appointments attended(From baseline to nine-month follow-up assessment.)
- Quality adjusted life years(From baseline to nine-month follow-up assessment.)
- Utilization of healthcare resources(From baseline to nine-month follow-up)
研究者
Jasper Palmier-Claus
Chief Investigator; Senior Lecturer; Principal Clinical Psychologist
Lancaster University