Co-design of an oral health intervention (HABIT) delivered by health visitors for parents of children aged 9-12 months.

BACKGROUND: Dental caries (tooth decay) in children is a national public health problem with impacts on the child, their family and wider society. Toothbrushing should commence from the eruption of the first primary tooth. Health visitors are a key provider of advice for parents in infancy and are ideally placed to support families to adopt optimal oral health habits. HABIT is a co-designed complex behaviour change intervention to support health visitors' oral health conversations with parents during the 9-12-month universal developmental home visit. METHODS: A seven stage co-design process was undertaken: (1) Preparatory meetings with healthcare professionals and collation of examples of good practice, (2) Co-design workshops with parents and health visitors, (3) Resource development and expert/peer review, (4) Development of an intervention protocol for health visitors, (5) Early-phase testing of the resources to explore acceptability, feasibility, impact and mechanism of action, (6) Engagement with wider stakeholders and refinement of the HABIT intervention for wider use, (7) Verification, Review and Reflection of Resources. RESULTS: Following preparatory meetings with stakeholders, interviews and co-design workshops with parents and health visitors, topic areas and messages were developed covering six key themes. The topic areas provided a structure for the oral health conversation and supportive resources in paper-based and digital formats. A five-step protocol was developed with health visitors to guide the oral health conversation during the 9-12 month visit. Following training of health visitors, an early-phase feasibility study was undertaken with preliminary results presented at a dissemination event where feedback for further refinement of the resources and training was gathered. The findings, feedback and verification have led to further refinements to optimise quality, accessibility, fidelity and behaviour change theory. CONCLUSION: The co-design methods ensured the oral health conversation and supporting resources used during the 9-12 month visit incorporated the opinions of families and Health Visitors as well as other key stakeholders throughout the development process. This paper provides key learning and a framework that can be applied to other healthcare settings. The structured pragmatic approach ensured that the intervention was evidence-based, acceptable and feasible for the required context. TRIAL REGISTRATION: ISRCTN55332414, Registration Date 11/11/2021.

Recommendations for delivering oral health advice: a qualitative supplementary analysis of dental teams, parents' and children's experiences.

BACKGROUND: Tooth decay has a significant impact on children, their families and wider society. The dental consultation provides an opportunity to prevent tooth decay by engaging in an effective oral health conversation with parents and children. However, there is limited literature which explores how these oral health conversations are delivered, received, and understood. AIM: To explore the common facilitators of delivering oral health advice from dental teams, parents' and children's experiences, to identify and inform practical recommendations for clinical practice. METHOD: The current paper used a qualitative supplementary analysis to reanalyse data of existing published studies by applying a different research question. Qualitative focus groups were undertaken following a semi-structured interview guide with 27 dental team members (dentists, dental nurses, practice managers and receptionists), 37 parents and 120 children (aged 7-10 years old) in the northern region of England. Thematic analysis informed the identification of themes and aggregation of findings. RESULTS: Three overarching themes were developed: (1) An engaging and personalised dental visit for parents and children; (2) Dental teams, parents and children working collaboratively to improve oral health habits; and (3) Recommending appropriate oral health products. Many parents and children had little recollection of any preventive oral health conversations when visiting the dentist. Practical solutions were identified by different stakeholders to facilitate three-way, personalised, non-judgemental and supportive oral health conversations. Adopting these innovative approaches will help to enable parents and their children to adopt and maintain appropriate oral health behaviours. CONCLUSION: Understanding the context and triangulating the experiences of stakeholders involved in preventive oral health conversations for young children is an essential step in co-designing a complex oral health intervention. This study has provided recommendations for dental practices and wider paediatric health care services. Furthermore, the findings have informed the design of a complex oral health intervention called "Strong Teeth".

"Strong Teeth": the acceptability of an early-phase feasibility trial of an oral health intervention delivered by dental teams to parents of young children.

BACKGROUND: Dental caries (tooth decay) in children is a worldwide public health problem. The leading cause of caries is poor oral hygiene behaviours and the frequent consumption of sugary foods and drinks. Changing oral health habits requires effective behaviour change conversations. The dental practice provides an opportunity for dental teams to explore with parents the oral health behaviours they undertake for their young children (0-5 years old). However, evidence suggests that dental teams need further support, training and resources. Therefore, "Strong Teeth" (an oral health intervention) was co-developed to help dental teams undertake these behaviour change conversations. The current paper will explore the acceptability of the "Strong Teeth" intervention with dental teams and parents of children aged 0-5 years old using multiple datasets (interviews, focus groups and dental team member diaries) METHODS: Following the delivery of the "Strong Teeth" intervention, qualitative interviews with parents and focus groups with dental team members were undertaken. Interviews were audio-recorded, transcribed and analysed using a theoretical framework of acceptability. The self-reported dental team diaries supplemented the interviews and focus groups and were analysed using framework analysis. RESULTS: Four themes were developed: (1) integration within the dental practice; (2) incorporating the Oral-B electric toothbrush; (3) facilitating discussions and demonstrations; and (4) the practicality of the Disney Magic Timer app. Overall, the "Strong Teeth" intervention was acceptable to parents and dental teams. Parents felt the Oral-B electric toothbrush was a good motivator; however, the Disney Magic Timer app received mixed feedback on how well it could be used effectively in the home setting. Findings suggest that the intervention was more acceptable as a "whole team approach" when all members of the dental practice willingly participated. CONCLUSIONS: There are limited studies that use a robust process evaluation to measure the acceptability of an intervention. The use of the theoretical framework of acceptability helped identify aspects of the intervention that were positive and helped identify the interventions areas for enhancement moving forwards. Future modifications include enhanced whole team approach training to optimise acceptability to all those involved. TRIAL REGISTRATION: ISRCTN Register, (ISRCTN10709150).

Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio.

BACKGROUND: The Covid-19 pandemic had a profound effect on the delivery of healthcare research. Covid-19 research was prioritised and many non-essential trials were paused. This study explores the engagement experiences of trial participants', PPIE contributors' and trial staff during the Covid-19 pandemic and towards recovery and restoring a diverse and balanced UK clinical trials portfolio. METHODS: Interviews and focus groups were undertaken with PPIE contributors, trial participants and trial staff members from NIHR research trials across the UK (November 2020-June 2021) across portfolio specialities: Cancer, Oral and Dental Health, Musculoskeletal Disorders, Cardiovascular Disease, Neurological Disorders, Primary Care, and Conditions associated with susceptibility to Covid-19 (Diabetes, Stroke, Respiratory Disorders). Topic guides were developed for each participant group and interviews were conducted over Zoom. The transcripts were analysed using codebook thematic analysis in NVivo (V.12). RESULTS: 106 participants comprising, 45 PPIE contributors, 27 trial participants and 34 trial staff members were recruited. Three themes to engagement with trials during Covid-19 were developed. 1) Ensuring continued contact. Continued and tailored communication, having a trial point of contact and regular updates all enhanced trial engagement and retention. Patients' unfamiliarity with materials being sent electronically reduced engagement and trust. 2) A balanced move to remote consultations. Remote follow-up and monitoring were convenient and allowed for wider recruitment across the UK. Participants were more likely to discuss personal subjects in their own homes. Remote visits lacked a personal touch, some concerns over missed diagnoses or being unable to appreciate the situation, technical abilities or equipment failures were seen as barriers, especially for disadvantaged or older people. 3) The importance of feeling fully informed. Factors that supported attendance were knowledge about trial conduct adherence to Covid-19 regulations, social distancing, clear signage at the site and opportunities to ask questions. Barriers included not knowing what to expect and not feeling safe with rules and regulations. CONCLUSIONS: Our findings highlight a number of ways to future proof trial delivery against future pandemics or disruptions such as offering online options to participate in research, ensuring consistent communication between participants and the research team, making sure participants feel fully informed and the continued reassurance of safety in the clinical setting.

HABIT (Health visitors delivering Advice in Britain on Infant Toothbrushing): a qualitative exploration of the acceptability of a complex oral health intervention.

BACKGROUND: To explore the acceptability of the oral health intervention, HABIT (Health visitors delivering Advice in Britain on Infant Toothbrushing) to parents with young children aged 9-12 months and health visitors. METHODS: Following the delivery of the universal oral health intervention called HABIT, qualitative semi-structured interviews with parents and focus groups with health visitors were undertaken. Interviews were audio-recorded and transcribed. Health visitors completed self-reported diaries after delivering the HABIT intervention with parents. The qualitative data was analysed using framework analysis (guided by a theoretical framework of acceptability). RESULTS: Seventeen parents were interviewed, and five health visitors and three nursery nurses participated in two focus groups. Parents reported health visitors to be 'trusted' and valued the reassurance provided during the HABIT visit. Health visitors found the HABIT training and resources useful and valued the consistency and increased confidence in undertaking oral health conversations. There were, however, challenges in changing behaviour where families faced competing demands on time and resources. Both health visitors and parents described the importance of the intervention's timing and suggested that multiple visits may be needed to support optimal oral health habits. CONCLUSION: The HABIT intervention was acceptable to parents and health visitors. Health visitors would welcome a further refinement to enhance intervention delivery that specifically achieves a balance between using a guided script and retaining the flexibility to adapt the conversation to suit the needs of individual families. This, in turn, will maximise impact and enable parents of young children to adopt and maintain optimal home-based oral health behaviours for their child.

HABIT: Health visitors delivering Advice in Britain on Infant Toothbrushing - an early-phase feasibility study of a complex oral health intervention.

OBJECTIVES: To conduct an early-phase feasibility study of an oral health intervention, Health visitors delivering Advice on Britain on Infant Toothbrushing (HABIT), delivered by Health Visitors to parents of children aged 9-12 months old. DESIGN: A mixed-methods, early-phase, non-controlled, feasibility study. PARTICIPANTS: Recruitment consisted of Group A-HABIT-trained Health Visitors (n=11) and Group B-parents of children aged 9-12 months old about to receive their universal health check (n=35). SETTING: Bradford, West Yorkshire, UK. INTERVENTION: A multidisciplinary team co-developed digital and paper-based training resources with health visitors and parents of young children. The intervention comprised of two components: (A) training for health visitors to deliver the HABIT intervention and (B) HABIT resources for parents, including a website, videos, toothbrushing demonstration and a paper-based leaflet with an oral health action plan. PRIMARY AND SECONDARY OUTCOME MEASURES: Recruitment, retention and intervention delivery were analysed as key process outcomes for Groups A and B. Group B demographics, self-reported toothbrushing behaviours, dietary habits and three objective measures of toothbrushing including plaque scores were collected at baseline, 2 weeks and 3 months post intervention. RESULTS: HABIT intervention delivery was feasible. Although the intended sample size was recruited (Group A=11 and Group B=35) it was more challenging than anticipated. Retention of Group B participants to final data collection was satisfactory (n=26). Total compliance with toothbrushing guidelines at baseline was low (30%), but significantly improved and was maintained 3 months after the intervention (68%). Plaque scores improved post intervention and participants found video recording of toothbrushing acceptable. Dietary habits remained largely unchanged. CONCLUSION: This feasibility study has demonstrated that HABIT is an appropriate oral health intervention. Adaptions to the study design are recommended to maximise recruitment and data collection in a definitive study. These quantitative findings have demonstrated an early signal of impact for improved oral health behaviours for young children at high risk of decay. TRIAL REGISTRATION NUMBER: ISRCTN55332414.

"Strong Teeth"-a study protocol for an early-phase feasibility trial of a complex oral health intervention delivered by dental teams to parents of young children.

BACKGROUND: Dental attendance provides an important opportunity for dental teams to explore with parents the oral health behaviours they undertake for their young children (0-5 years old). For these discussions to be effective, dental professionals need to be skilled in behaviour change conversations. The current evidence suggests that dental teams need further support, training and resources in this area. Therefore, the University of Leeds and Oral-B (Procter & Gamble Company) have worked with the local community and dental professionals to co-develop "Strong Teeth" (an oral health intervention), which is delivered in a general dental practice setting by the whole dental team. The protocol for this early phase study will explore the feasibility and acceptability of the Strong Teeth intervention to parents and the dental team, as well as explore short-term changes in oral health behaviour. METHODS: Forty parents (20 of children aged 0-2 years old, and 20 of children aged 3-5 years old) who are about to attend the dentist for their child's regular dental check-up will be recruited to the study. Parents and children will be recruited from 4 to 8 different dental practices. In the home setting, consent and baseline oral health behaviour data will be collected. The researchers will ask parents questions about their child's oral health behaviours, including toothbrushing and diet. Three different proxy objective measures of toothbrushing will be collected and compared with self-report measures of parental supervised toothbrushing (PSB). DISCUSSION: The parent and child will then attend their dental visit and receive the Strong Teeth intervention, delivered by the dental team. This intervention should take 5-15 min to be delivered, in addition to the routine dental check-up. Furthermore, children aged 0-2 years old will receive an Oral-B manual children's toothbrush, and children aged 3-5 years old will receive an Oral-B electric rechargeable children's toothbrush. At 2 weeks and 2-3 months following the Strong Teeth intervention, further self-report and objective measures will be collected in the parent/child's home. This data will be supplemented with purposively sampled qualitative interviews with parents (approximately 3 months following the intervention) and dental team members (following delivery of the intervention). TRIAL REGISTRATION: ISRCTN Register, (ISRCTN10709150).