A Randomised Feasibility Trial of an Intervention Using Mental Health Support Workers as Link Workers to Improve Dental Visiting in People With Severe Mental Illness: The Mouth in Mind Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 10
- 主要终点
- Recruitment rates - feasibility criteria
研究概览
简要总结
To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health.
- To understand what constitutes best practice when delivering link work around dental visiting.
- To identify what training needs exist for support workers around link work.
- To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting.
- To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population.
- To explore if, and how, patients with severe mental illness engage with a link work intervention.
- To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.
详细描述
Background and study aims
Severe mental ill health (SMI) affects around 1% of the population. It includes depression, psychosis, and bipolar disorder. People with experience of SMI are more likely to have problems with their teeth and gums. This includes more missing, filled, and decayed teeth than people without SMI. Having poor oral health can impact a lot of everyday activities like eating, speaking and smiling. It can affect how patients see themselves and their mental health.
Dentists can treat many early teeth and gum problems. However, very few people with SMI attend regular dental appointments. Instead, they are more likely to seek help when in crisis and invasive treatments are the only option. Accessing a dentist for people with SMI can be difficult for lots of reasons. People can feel helpless, fearful, or unmotivated to attend. They can have difficulty booking, planning, and getting to appointments. They may struggle to pay for or access free dental care. Unfortunately, existing dental initiatives have not addressed the barriers facing this group. They do not help people with SMI to attend the dentist.
The investigators want to help people with SMI to access dental care. The study will use mental health support workers who are already working in the National Health Service (NHS). They will link people receiving care from mental health teams with dental services. The support workers will help people to book, plan, and attend regular dental appointments. They will support patients to apply for financial support. People call this type of support link work. Research has indicated that link work can increase dental visits in people who might not normally attend. Mental health support workers already do link work for other appointments. Link work has been used to help other vulnerable groups of people (e.g. children) around dental care. However, this will be the first use of link work to help people with SMI to attend the dentist.
Who can participate?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged >18 years
- •Able to provide informed consent
- •Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral
- •No routine and planned dental appointment in the past 3 years. The person should not have accessed a dental service (e.g. high street dentist, special care dentist service) for routine or planned dental care in the past 3 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. The researchers do not consider emergency dental care (e.g. attendance at A&E, dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
- •Exclusion criteria:
- •Inpatient status on a psychiatric or secure ward. The researchers will allow participants in supported living to take part as long as they are in receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention for Psychosis Service
- •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). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and the referrer in approximately 1 month's time (or a time period agreed in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible.
- •Enrolled in a dental trial
排除标准
- 未提供
结局指标
主要结局
Recruitment rates - feasibility criteria
时间窗: 7 months
Data on ability to recruit randomise 84 participants to target in a 7-month recruitment window. Green ≥80%. Amber 60-79%. Red ≤59%.
Clinical exam - feasibility criteria
时间窗: 9 months
Percentage of participants completing the dental examination. Green ≥80%. Amber 60-79%. Red: ≤59%.
Visiting data - feasibility criteria
时间窗: 9 months
Percentage of participants with available data on dental visiting via self-report or BSA data. Green ≥90%. Amber 60-89%. Red ≤59%.
Adherence to intervention - feasibility criteria
时间窗: 9 months
Percentage of participants receiving intervention ≥1 sessions during nine month window. Green ≥80%. Amber 60-79%. Red ≤59%.
Intervention and trial protocol - feasibility criteria
时间窗: 9 months
Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. This will be via qualitative interviews with service users (participants), research staff (link workers, research assistants), and key stakeholders (referrers, managers, commissioners). Audio recordings of sessions and field notes will also be analysed.
Safety of intervention - feasibility criteria
时间窗: 9 Months
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms. The authors will discontinue the trial if the intervention or procedures elevate risk.
次要结局
- The number of planned dental appointments attended(Baseline and 9 month assessments)
- Confidence around dental visiting(Baseline and 9 month assessments)
- Brief Pain Inventory - short form(Baseline and 9 month assessments)
- Oral Health Impact Profile(Baseline and 9 month assessments)
- The number of eligible participants able to access free or subsidised dental care(Baseline and 9 month assessments)
- Oral health self-management - tooth brushing, mouth wash, and flossing(Baseline and 9 month assessments)
- Manchester Orofacial Pain Disability Scale(Baseline and 9 month assessments)
- Modified Dental Anxiety Scale(Baseline and 9 month assessments)
- Patient Health Questionnaire (PHQ)(Baseline and 9 month assessments)
- EuroQol 5 Dimension (EQ-5D-5L)(Baseline and 9 month assessments)
- Self reported attendance at a planned dental appointment(9 months)
- Business services authority recorded attendance at a planned dental appointment(9 months)
- Rosenberg Self-esteem Scale (RSES)(Baseline and 9 month assessments)
- Number of decayed, missing, or filled teeth (DMFT) via dental examination(Baseline and 9 months)
- Modified Plaque Score via dental examination(Baseline and 9 months)
- Pulpal involvement, ulceration due to trauma, fistula, and abscess (PUFA) via dental examination(Baseline and 9 months)
研究者
Jasper Palmier-Claus
Principle Investigator
Lancaster University