Evaluation of the Use of a Novel Oral Health Screening Instrument by Caregivers in Nursing Homes
NCT Number: NCT06536322
Acronym: OHS-interRAI
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Health|Old Age; Dementia|Long-Term Care|Nursing Homes|Geriatric Assessment|Mouth Diseases
Interventions: OTHER: OHS-interRAI
Sponsor: KU Leuven
Collaborators: Research Foundation Flanders
Sex: ALL
Age: OLDER_ADULT
Enrollment: 462
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-01-03
Completion Date: 2025-02-28
Locations: KU Leuven, Leuven, Belgium

Summary:
BACKGROUND: Oral health of nursing home residents is often poor. Oral health is related to general health, quality of life and well-being. Health care providers in nursing homes can be seen as important intermediaries to improve oral health as they are responsible for the residents' daily care and as they could regularly check resident's oral health.

The goal of this interventional study is to evaluate the use of a new oral health screening tool for older adults in nursing homes (OHS-interRAI) in an everyday context. This tool is included in the Belgian version of the International Resident Assessment Instrument for long-term care facilities and will be used by healthcare providers without a dental background. The evaluation will be done at different levels using mixed methods.

The main questions this study aims to answer at level of the residents are:

* What is the effect of regular oral health assessment on oral health of the residents?
* How do residents perceive oral health and experience the regular oral health assessments?

At level of the health care providers the main questions are:

* How do they experience the use of the OHS-interRAI for oral health assessments?
* To what extent are the assessments by health care providers comparable to assessments performed by oral health professionals?

METHODS: This research will compare the outcomes of nursing homes using the OHS-interRAI with outcomes of nursing homes using the oral health screening tool which is currently used in Belgian nursing homes. Nursing homes will be assigned randomly to the different groups. Both healthcare providers and residents assign for participation. Healthcare providers will follow a training on how to perform the screening with the OHS-interRAI and to monitor residents' oral health. Residents agree to regular oral health assessments by their healthcare providers every six months over a 2-years period.

Primary Outcome Measures: Oral health data measured with interRAI LTCF, The oral health related data measured with interRAI LTCF consists of 6 items which are scored dichotomously. The optimized oral health-related section (OHS-interRAI) consists of 9 items and result in categorized data: 1= good condition, 2= bad condition, 3= not judgable, 4= not applicable. As only scores 1 and 2 distinguish between good and bad condition, the items can be seen as dichotomous variables.

Oral health data is collected by healthcare providers and dentists., every six months over a 2-years period
Secondary Outcome Measures: Oral Hygiene Index, The Oral Hygiene Index (OHI) (Greene \& Vermillion, 1960) assesses oral hygiene through two components: the Debris Index (DI) and the Calculus Index (CI), which measure the amount of plaque and calculus on the tooth surfaces, respectively. Both DI and CI are evaluated on the buccal and lingual/palatal surfaces of teeth per sextant. Scoring for DI and CI is as follows: 0 (no debris/calculus), 1 (covering up to 1/3 of the surface), 2 (covering 1/3 to 2/3 or small subgingival areas), and 3 (covering more than 2/3 or a wide band of subgingival calculus in the cervical area). The DI and CI range from 0 to 6, with the OHI being the sum of both, ranging from 0 to 12. Interpretation: 0-2 (acceptable), 2.1-5.9 (moderate), 6-12 (poor) (Mühlemann, 1976)., every six months over a 2-years period|Modified Gingival Index, The Modified Gingival Index (MGI) (Lobene et al., 1986), based on the Gingival Index (GI) by Loë and Silness (1963), is a non-invasive method for research to monitor changes in gingival health. It assesses the buccal and lingual/palatal gingival margin of the tooth with worst gingival health per quadrant. MGI scoring per gingival unit: 0 (normal), 1 (mild inflammation in part of the gingival unit), 2 (mild inflammation of the entire gingival unit), 3 (moderate inflammation), and 4 (severe inflammation). Interpretation: 0.1-1.0 (mild inflammation of any portion of the gingiva), 1.1-2.0 (mild inflammation of the entire gingiva), 2.1-3.0 (moderate inflammation), and 3.1-4.0 (severe inflammation) (Sedky, 2018)., every six months over a 2-years period|PUFA-index - Pulp, Ulceration, Fistel, Abscess, The PUFA index will be used to assess the presence of oral conditions resulting from untreated caries (Monse et al., 2010). The PUFA was visually assessed with the use of a dental mirror. This index ranges from 0-32 and is scored as follows: P= Pulpal involvement is recorded when the opening of the pulp chamber is visible or when the coronal tooth structures have been destroyed by the carious process and only roots or root fragments are left; U= Ulceration due to trauma from sharp pieces of tooth when sharp edges of a dislocated tooth with pulpal involvement or root fragments have caused traumatic ulceration of the surrounding soft tissues; F= Fistula is scored when a pus releasing sinus tract related to a tooth with pulpal involvement is present; A= Abscess is scored when a pus containing swelling related to a tooth with pulpal involvement is present., every six months over a 2-years period|Interview data, Data from in-depth interviews consist of older people's experience with their own oral health, the oral care performed, the importance of oral care, as well as the importance of the regular oral health assessment and the actions taken afterwards., interviews will be conducted within 14 to 80 days following the baseline oral health assessment|Oral Health Impact Profile (OHIP-14), The OHIP-14 is an Oral Health-Related Quality of Life 14-items instrument which is an internationally validated instrument that measures the degree of self-rated oral health and satisfaction with the oral health status.

The OHIP-14 will be used to assess the older people's oral health-related quality of life., will be assessed within 14 to 80 days following the baseline oral health assessment
Other Outcome Measures: Qualitative data on the use of the OHS-interRAI for oral health assessments, The use of the OHS-interRAI will be evaluated qualitatively by means of focus group discussions with healthcare providers and observations., 3 months after intervention and one year after intervention