Daily Mouth Care to Prevent Pneumonia in Nursing Homes

NCT ID: NCT03817450

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Aging; Nursing Home; Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Daily Mouth Care

The intervention consists of training in Mouth Care Without a Battle (MCWB) techniques and support in established quality improvement techniques. MCWB is a system-level, evidence based, tested approach to person-centered daily mouth care, which includes tooth-brushing, flossing, care of the gums, and denture care. MCWB provides training to all certified nursing assistants (CNAs) and nursing supervisors, and also supports the designation and specialized training of a CNA to serve as a dedicated, full-time Oral Care Aide (OCA) to provide mouth care to the residents who are at greatest risk for pneumonia and require specialized support to achieve good oral hygiene.

Group Type: EXPERIMENTAL

Daily Mouth Care

Intervention Type: BEHAVIORAL

Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention nursing homes.

Standard Mouth Care

Nursing homes will continue to provide standard mouth care to all residents. Nursing home staff will not receive training or supplies in the control condition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Daily Mouth Care

Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention nursing homes.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheryl Zimmerman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

References

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.

Reference Type: DERIVED

PMID: 36383760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32558913 (View on PubMed)

Other Identifiers

4R01HS022298-03

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

13-2072

Identifier Type: -

Identifier Source: org_study_id