Clinical trial NCT06755411: Oral Health and Fundamental of Care Program
Official title: Oral Health Promotion and Fundamental of Care: an Evidence-based Practice Educational Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene, Oral Health
Oral Cavity
Nursing Care
Nursing Education
Keywords: oral hygiene
oral health
fundamental of care
nursing care
nursing education
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2025-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study design: the effectiveness of an evidence-based practice educational program to improve the quality of oral care has been evaluated in a before-and-after quasi-experimental study.

The study adhered to The TREND statement guidelines, which provide a 22-item checklist designed to ensure consistent reporting of nonrandomized controlled trials. This statement, which is complementary to the widely recognized CONSORT statement for randomized controlled trials, was utilized to guide the study's methodology (Des Jarlais, Lyles, Crepaz, \& TREND Group, 2004).
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge)
timeFrame: T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: AOU Maggiore della Carità
Study officials:
affiliation: AOU Maggiore della Carità di Novara
name: Chiara Gallione, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Maggiore della Carità di Novara
name: Cristian Vairo, PhD st, MSN, RN
role: STUDY_CHAIR
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