Oral Health and Fundamental of Care Program

Not Applicable

Completed

• Conditions: Oral Hygiene, Oral Health; Oral Cavity; Nursing Care; Nursing Education

• Registration Number: NCT06755411
• Lead Sponsor: Alberto Dal Molin

Brief Summary

Introduction:

Oral health significantly impacts daily life, affecting communication, nutrition, emotional expression, self-esteem, and overall quality of life. Poor oral health is associated with conditions ranging from caries and periodontal disease to systemic issues such as diabetes, cardiovascular disorders, and increased mortality.

Background and Rationale:

Oral frailty, a concept originating in Japan in 2013, highlights the deterioration of oral function due to aging, potentially leading to malnutrition and systemic health impacts. The 2017 Global Burden of Disease Study emphasized oral health as an ongoing global challenge, identifying caries, severe periodontitis, and edentulism as prevalent issues. Preventable oral diseases contribute significantly to health disparities and systemic illnesses.

Aims:

Primary: To evaluate the impact of an educational intervention to implement evidence-based guidelines for oral health care in adult inpatients.

Secondary: To assess the concordance between different assessment tools and the improvement in knowledge of healthcare workers following training.

Methods:

Study Design: A before-and-after interventional study comparing pre- and post-educational intervention implementation cohorts.

Setting: Medical Department, Maggiore della Carità Hospital, Novara, Italy. Eligibility: Adults aged ≥18 years admitted for inpatient care who consent to participate.

Outcomes: Improvements in oral health outcomes as assessed by the OHAT tool and secondary metrics such as knowledge improvement in healthcare staff.

Intervention:

Training Sessions: Healthcare workers receive education on oral health guidelines, including practical and simulation-based activities.

Implementation: Adoption of evidence-based practices for oral health care.

Evaluation Phases:

Phase 1 (Baseline): Assessment of oral health in patients using OHAT and a structured evaluation protocol.

Phase 2 (Intervention): Educational sessions for healthcare workers. Phase 3 (Post-Implementation): Follow-up assessments using the same tools and methods as Phase 1.

Data Analysis:

Statistical methods include descriptive analysis, repeated measures models, and pre-post intervention comparisons. A significance level of 0.05 will be applied.

Sample Size:

A minimum of 48 participants (24 per cohort) is required, based on a hypothesised effect size of 0.5 with 80% power and a significance level of 0.05.

Ethical Considerations:

The protocol will be submitted for ethical approval. Data will be anonymised and handled per EU Regulation 2016/679 (GDPR).

Dissemination of Results:

Findings will be published in peer-reviewed journals and presented at conferences, maintaining participant confidentiality.

Detailed Description

Background Oral health care encompasses all practices of education, motivation, prevention, assessment, and care delivery aimed at preventing and/or eliminating soft and hard tissue pathologies within the oral cavity or slowing their progression.

The literature highlights that oral hygiene needs are often not addressed at the same level as other health needs, and certain populations are at a higher risk of poor oral health compared to others.

Providing effective oral hygiene is essential to ensuring both local and systemic well-being. Oral health education aims to enhance knowledge and skills while promoting good practices to reduce morbidity associated with the oral cavity. Conversely, a lack of education and training strategies, as well as failure to implement preventive measures, inevitably leads to a progressive increase in oral health issues.

In the context of person-centered care, the standards derived from the delivery of fundamental care represent the baseline below which care quality should not fall. These standards are supported by robust evidence and defined through Clinical Practice Guidelines (CPGs).

Based on these considerations, a before-and-after study was designed to evaluate the effectiveness of an evidence-based guideline implementation program for oral health care and management, targeting nursing staff and healthcare assistants in the Internal Medicine Ward of the AOU Maggiore della Carità, Novara.

Global and Local Context The Global Burden of Disease Study 2017 provided a global perspective on the prevalence, incidence, and disability-adjusted life expectancy associated with oral health conditions, stratified by age, gender, and country from 1990 to 2017. The results demonstrate that oral health conditions and their management remain a significant global challenge.

Worldwide, oral health pathologies affect 3.5 billion individuals, including:

2.4 billion with untreated caries in permanent teeth (35% of the global population).

796 million with severe periodontitis. 532 million with untreated caries in primary teeth. 267 million with total edentulism. 139 million with other pathological conditions.

Oral cancer is among the top three cancers in the Pacific region of Asia. Most oral health conditions are preventable, can be intercepted early, and treated effectively. Notably, there is a well-established correlation between proper oral care and systemic conditions such as cardiovascular disorders, hypertension, stroke, diabetes, dementia, respiratory diseases, and increased mortality.

Assessment Tools for Oral Health Various tools are available to assess oral health status or estimate risks. The Registered Nurses' Association of Ontario (RNAO) recommends standardized approaches or validated tools for comprehensive assessment of oral and peri-oral structures, including evaluation of breath, hygiene, and pain.

The Oral Health Assessment Tool (OHAT), tested in various settings for adults, is practical, reliable, and quick for use by non-specialized healthcare staff. A validated Italian version is also available.

Study Objective This before-and-after study aims to assess the impact of implementing evidence-based guidelines for oral health care among adult patients admitted to a medical ward, focusing on changes in oral health-related outcomes.

Secondary Objectives:

Estimate concordance between adopted assessment tools. Evaluate changes in healthcare staff's knowledge of guidelines and best practices for oral health care.

Methodology Data collection will follow specific time points: upon admission, every five days, and at discharge. Assessments will include the OHAT scale and a protocol tailored for specialized oral health evaluations.

Primary Outcome: oral health improvement assessed using OHAT. Secondary Outcomes: Concordance between OHAT and standard protocol tailored for specialized oral health evaluations.

Knowledge improvement among staff pre- and post-training.

Intervention Phases

1. Baseline Evaluation (T0): Oral health assessment using OHAT and per standard protocol upon admission, intermediate days, and discharge.

2. Training Program: Implementation of RNAO guidelines in two stages:

Healthcare Staff Education Clinical workflow restructuring.

3. Post-Implementation Evaluation (T1): Reassessment using the same tools.

Sample Size and Statistical Analysis A minimum of 24 patients per group is required to detect an effect size of 0.5 with 80% power at a 0.05 significance level. Statistical analysis will compare changes in OHAT scores between groups using repeated measures models, chi-square tests, or non-parametric equivalents as appropriate.

Ethical Considerations The protocol will be submitted to the Institutional Ethics Committee for approval. Participants will provide informed consent, and data will be handled anonymously in compliance with GDPR regulations. Any protocol amendments will be reported promptly.

Conclusion This study seeks to provide evidence for the effectiveness of training programs and guideline implementation in improving oral health care practices, ultimately benefiting patient outcomes both locally and systemically.

Study Timeline

• Study Start: 2023-05-16
• Primary Completion: 2023-12-11
• Study Completion: 2024-07-09
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Status Verified: 2025-01
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who met the requirements for the study should have been at least 18 years old, be admitted on a regular schedule, and be able to understand and give informed consent for the study. Patients assigned, even temporarily, to other inpatient wards were not eligible
• Only patients admitted to Internal General Medicine Ward at Maggiore della Carità Hospital, Novara, a 640-bed university hospital in northern Italy.

Exclusion Criteria

• Patients unable to understand and consent, with critical conditions preventing oral cavity assessment (e.g., presence of non-removable non-invasive ventilatory support devices, transient disorientation, unwillingness to participate) were excluded. Patients had the right to withdraw their participation agreement at any point during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge)	T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)	The Oral Health Assessment Tool (OHAT) uses a Likert scale ranging from 0 (very healthy) to 2 (very unhealthy) for each item, with a total of 8 items assessed. The maximum score is 16, and higher scores indicate worse oral health conditions.; The OHAT average score differences in the pre-post-intervention phases, assessing if the educational intervention produces an effect of reducing the progression of oral cavity deterioration. Regarding the analysis of mouth conditions, any changes between admission and discharge were assessed with the OHAT tool. Because the data are correlated (evaluated at separate times) and classified into three groups (good, sufficient, and inadequate) Bhapkar's test was applied. The same assessment was done assuming that just the difference between T5 and T100 is reported, excluding the first evaluation upon admission, because it is influenced by oral hygiene practices carried out at home or in other setting.

Trial Locations

Locations (1)

AOU Maggiore della Carità; 🇮🇹 Novara, Italy