Clinical trial NCT03817450: Daily Mouth Care to Prevent Pneumonia in Nursing Homes
Official title: Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Nursing Home
Pneumonia
Keywords: Mouth Care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 1416
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1a. Compare the incidence of pneumonia in seven mouth care NHs to the incidence of pneumonia in seven control NHs for two years.

Secondarily:

1b. Compare the case-adjusted incidence of pneumonia in mouth care NHs to the case-adjusted incidence in control NHs, and evaluate whether the intervention effects for pneumonia incidence are modified by resident-level risk factors for pneumonia.

1c. Examine the relationship between the overall incidence of pneumonia and change in average oral health status, as measured by the plaque and gingival indices of cross-sectional random samples of 60 residents per NH at baseline and at the end of the study.

2. Examine the implementation and sustainability of the mouth care program, including: (a) staff self-efficacy to provide mouth care; (b) frequency of mouth care and related supervision; (c) use of mouth care products; (d) barriers and facilitators to implementation; and (e) cost of the mouth care program.

3. In regard to secondary outcomes of hospitalization and mortality: 3a. Compare differences in hospitalization and mortality rates (pneumonia and all cause) from baseline through two years for mouth care and control NHs.

3b. Assess the likelihood that the intervention is cost-saving, and estimate the cost per hospitalization avoided attributable to the mouth care program.

These aims will be addressed in a two year matched pairs cluster randomized trial will be conducted in seven pairs of NHs; one half of each pair will be randomly assisted to receive the intervention (MCWB), and the other half will be assigned to the control condition.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of pneumonia over time
timeFrame: Collected every four months during the 2 year study
Secondary outcomes:
measure: Incidence of hospitalizations over time
timeFrame: Collected every four months during the 2 year study
measure: Mortality
timeFrame: Collected every four months during the 2 year study
measure: Staff self-efficacy to provide mouth care
timeFrame: Baseline and 24 months
measure: Frequency of mouth care
timeFrame: Collected during the entire 2 year study
measure: Number of times mouth care products were used
timeFrame: Collected during the entire 2 year study
Other outcomes:
measure: Intervention costs
timeFrame: Collected during the entire 2 year study
measure: Staff Turnover
timeFrame: Collected during the entire 2 year study
measure: Change in Plaque Index Score for Long-Term Care (PI-LTC) over time
timeFrame: Baseline and 24 months
measure: Change in Gingival Index Score for Long-Term Care (GI-LTC) over time
timeFrame: Baseline and 24 months
measure: Change in Denture Plaque Index Score (DPI) over time
timeFrame: Baseline and 24 months
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sheryl Zimmerman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Liu C, Lin J, Ng L, Needleman I, Walsh T, Li C. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev. 2022 Nov 16;11(11):CD012416. doi: 10.1002/14651858.CD012416.pub3.
citation: Zimmerman S, Sloane PD, Ward K, Wretman CJ, Stearns SC, Poole P, Preisser JS. Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial. JAMA Netw Open. 2020 Jun 1;3(6):e204321. doi: 10.1001/jamanetworkopen.2020.4321.