Clinical trial NCT05545228: The Mouth Matters in Mental Health Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorders, Severe
Keywords: Mental Health
Oral Health
Dentistry
Lead sponsor: Lancaster University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A feasibility single-blinded randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

1. To understand what constitutes best practice when delivering link work around dental visiting.
2. To identify what training needs exist for support workers around link work.
3. To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting.
4. To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population.
5. To explore if, and how, patients with severe mental illness engage with a link work intervention.
6. To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.

Detailed description: 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?

People with a severe mental health difficulties currently accessing secondary care mental health services at the point of referral (e.g. community mental health team, early intervention for psychosis service), but who have not had a routine dental appointment in the past three years.

What does the study involve?

Participants will be randomly allocated to receiving treatment as usual or treatment as usual plus the link work intervention. This will be decided by chance. The investigators will measure how often people in both groups visit the dentist. They will also assess the state of their teeth and gums. They will collect this data when people come into the study and after nine months. The authors will offer interviews to patients and staff involved in the trial to understand how they found their involvement.

What are the possible benefits and risks of participating?

The intervention aims to support people to access dental services. However, it is currently untested, which is the reason for doing the research.

When is the study starting and how long it is expected to run for?

Recruitment for the trial is starting in September 2022 and will run for seven months. The whole project is scheduled to finish in April 2024.

Who is funding the study?

The National Institute of Health Research (NIHR) Health and Social Care Delivery Research (HS\&DR) scheme are funding the project.

Eligibility criteria: Inclusion Criteria:

1. Aged \>18 years
2. Able to provide informed consent
3. Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral
4. 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:

1. 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
2. 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.
3. Enrolled in a dental trial

Primary outcomes:
measure: Recruitment rates - feasibility criteria
timeFrame: 7 months
measure: Visiting data - feasibility criteria
timeFrame: 9 months
measure: Clinical exam - feasibility criteria
timeFrame: 9 months
measure: Adherence to intervention - feasibility criteria
timeFrame: 9 months
measure: Intervention and trial protocol - feasibility criteria
timeFrame: 9 months
measure: Safety of intervention - feasibility criteria
timeFrame: 9 Months
Secondary outcomes:
measure: Brief Pain Inventory - short form
timeFrame: Baseline and 9 month assessments
measure: Manchester Orofacial Pain Disability Scale
timeFrame: Baseline and 9 month assessments
measure: Oral Health Impact Profile
timeFrame: Baseline and 9 month assessments
measure: Confidence around dental visiting
timeFrame: Baseline and 9 month assessments
measure: Rosenberg Self-esteem Scale (RSES)
timeFrame: Baseline and 9 month assessments
measure: Modified Dental Anxiety Scale
timeFrame: Baseline and 9 month assessments
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline and 9 month assessments
measure: EuroQol 5 Dimension (EQ-5D-5L)
timeFrame: Baseline and 9 month assessments
measure: The number of eligible participants able to access free or subsidised dental care
timeFrame: Baseline and 9 month assessments
measure: The number of planned dental appointments attended
timeFrame: Baseline and 9 month assessments
measure: Oral health self-management - tooth brushing, mouth wash, and flossing
timeFrame: Baseline and 9 month assessments
measure: Self reported attendance at a planned dental appointment
timeFrame: 9 months
measure: Business services authority recorded attendance at a planned dental appointment
timeFrame: 9 months
measure: Number of decayed, missing, or filled teeth (DMFT) via dental examination
timeFrame: Baseline and 9 months
measure: Pulpal involvement, ulceration due to trauma, fistula, and abscess (PUFA) via dental examination
timeFrame: Baseline and 9 months
measure: Modified Plaque Score via dental examination
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Ashton-under-Lyne
country: United Kingdom
facility: Pennine Care NHS Foundation Trust
state: Great Manchester
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
state: Great Manchester
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
city: Lancaster
country: United Kingdom
facility: Lancaster University
state: Lancashire
city: Preston
country: United Kingdom
facility: Lancashire and South Cumbria NHS Foundation Trust
state: Lancashire
Study officials:
affiliation: Lancaster University
name: Jasper Palmier-Claus, PhD, DClinPsy
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Rebecca Harris, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: