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临床试验/NCT06536322
NCT06536322进行中(未招募)不适用

Process and Outcome Evaluation of the Optimized Oral Health-related Section of the Belgian Resident Assessment Instrument and Its Training: a Cluster Randomized Controlled Trial

KU Leuven1 个研究点 分布在 1 个国家目标入组 462 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
KU Leuven
入组人数
462
试验地点
1
主要终点
Oral health data measured with interRAI LTCF

研究概览

简要总结

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.

详细描述

BACKGROUND: This research focuses on the oral health-related section within the interRAI Long-Term Care Facilities Assessment Instrument (interRAI LTCF). The interRAI LTCF instrument enables comprehensive, standardized evaluation of the needs, strengths and preferences of care-dependent older persons in nursing homes by their daily caregivers. The oral health-related section of the interRAI LTCF was recently optimized and validated by Krausch-Hofmann et al. (2021). The oral health section for use within the interRAI LTCF instrument (OHS-interRAI) differs from other oral health assessment tools because it is part of a holistic assessment (interRAI LTCF) which considers oral health as part of general health. Therefore it has the potential to integrate oral health care into overall care planning. The use of photographs facilitates detection of oral hygiene and oral health problems. Finally, when oral hygiene is deficient or when referral to a dentist is deemed necessary, the caregiver will be alerted by a Collaborative Action Point (CAP). This is an alert based on an evidence based algorithm that is activated when a problem is detected so caregivers become aware of the problem and can act accordingly. This type of alert is already used for other items in the interRAI LTCF and helps caregivers as well as clinicians to decide as to whether and how to intervene with the person and/or his family.

In Belgium, nursing homes use the the Belgian version of the interRAI LTCF instrument (BelRAI LTCF).

The objective of this research is to evaluate the use of the OHS-interRAI in Belgium at level of the residents and the caregivers. This study will generate longitudinal data on oral health and its associated factors among nursing home residents, using BelRAI LTCF.

RESEARCH QUESTIONS:

  1. Nursing home residents Study 1.1: Perspectives of nursing home residents on oral health and oral health care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Care providers and participants in the intervention group know they are testing a new tool. Care providers and participants in the control group continue care as usual and do not know about the new tool.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residents need to be 65 years or older
  • Residents have permanent residence in a nursing home

排除标准

  • Residents with a palliative health situation, assessed using the interRAI LTCF, are excluded.

结局指标

主要结局

Oral health data measured with interRAI LTCF

时间窗: every six months over a 2-years period

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.

次要结局

  • Oral Health Impact Profile (OHIP-14)(will be assessed within 14 to 80 days following the baseline oral health assessment)
  • Oral Hygiene Index(every six months over a 2-years period)
  • PUFA-index - Pulp, Ulceration, Fistel, Abscess(every six months over a 2-years period)
  • Modified Gingival Index(every six months over a 2-years period)
  • Interview data(interviews will be conducted within 14 to 80 days following the baseline oral health assessment)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joke Duyck

Principal Investigator

KU Leuven

研究点 (1)

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