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临床试验/NCT03817450
NCT03817450已完成不适用

Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach

University of North Carolina, Chapel Hill0 个研究点目标入组 1,416 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,416
主要终点
Incidence of pneumonia over time

研究概览

简要总结

This project will determine whether an evidence-based, tested, pragmatic, system-level, comprehensive mouth care program provided to nursing home residents can reduce the incidence of pneumonia. It also will examine matters related to implementation, sustainability, and cost. If effective, the investigators expect this program to be widely adopted and sustained, to result in fewer episodes of pneumonia, and to reduce health-care costs.

详细描述

Each year, almost two million episodes of pneumonia are suffered by nursing home (NH) residents across the United States, resulting in more deaths than from any other infection. Further, NH residents acquire pneumonia at a rate 6-10 times higher than older adults in the community, indicating that characteristics of these individuals and/or the NH settings put them at increased pneumonia risk.

Pneumonia is an inflammatory condition usually initiated by the introduction of bacteria into the lung, such as through aspiration. In aspiration, contents from the mouth, throat, or stomach that are colonized with pathogenic bacteria are inhaled into the lungs. Poor oral hygiene is therefore a critical risk factor for pneumonia because it increases the volume and infectious nature of secretions from the mouth and throat.

Considering the high rate of pneumonia in NHs and its relationship to oral hygiene, it should come as no surprise that mouth care provided in NHs is poor. Almost 90% of residents require help with tooth brushing, yet only 16% have their teeth brushed regularly. Reasons for insufficient care include time, other priorities, existing procedures, perceptions that oral health is not vital to overall health, and fear of resistant residents.

Evidence is emerging that improved oral care can prevent pneumonia. However, no studies have developed and tested a program designed specifically for widespread adoption and sustainability. Our research team developed the Mouth Care Without a Battle (MCWB) program, and in pilot-testing, MCWB significantly improved tooth brushing and flossing, reduced dental plaque and gingivitis (which harbor the bacteria that can cause pneumonia), and increased staff knowledge and attitudes related to mouth care.

If MCWB is effective in reducing pneumonia and related hospitalizations and mortality, it would constitute a major advance in disease prevention. Therefore, the aims of this evidence-based, tested, matched-pairs cluster randomized trial are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Residents who are at least 21 years of age and who reside in a participating nursing home
  • Residents who have natural teeth and/or dentures and do not require prophylactic antibiotics prior to a dental examination
  • Staff members who are at least 21 years of age and who work in a participating nursing home and speak English

排除标准

  • Residents with no natural teeth or dentures
  • Residents who require prophylactic antibiotics prior to a dental examination
  • Non-English speaking staff members
  • Staff members who do not provide direct care to residents

结局指标

主要结局

Incidence of pneumonia over time

时间窗: Collected every four months during the 2 year study

The total number of diagnosed cases of pneumonia

次要结局

  • Frequency of mouth care(Collected during the entire 2 year study)
  • Number of times mouth care products were used(Collected during the entire 2 year study)
  • Incidence of hospitalizations over time(Collected every four months during the 2 year study)
  • Mortality(Collected every four months during the 2 year study)
  • Staff self-efficacy to provide mouth care(Baseline and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

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