NCT03817450

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

4.3 years

First QC Date

January 23, 2019

Last Update Submit

November 11, 2019

Conditions

AgingNursing HomePneumonia

Keywords

Mouth Care

Outcome Measures

Primary Outcomes (1)

  • Incidence of pneumonia over time

    The total number of diagnosed cases of pneumonia

    Collected every four months during the 2 year study

Secondary Outcomes (5)

  • 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

  • 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

Other Outcomes (5)

  • Intervention costs

    Collected during the entire 2 year study

  • Staff Turnover

    Collected during the entire 2 year study

  • Change in Plaque Index Score for Long-Term Care (PI-LTC) over time

    Baseline and 24 months

  • +2 more other outcomes

Study Arms (2)

Daily Mouth Care

EXPERIMENTAL

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.

Behavioral: Daily Mouth Care

Standard Mouth Care

NO INTERVENTION

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.

Interventions

Daily Mouth CareBEHAVIORAL

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.

Daily Mouth Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 36383760DERIVED

  • 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.

    PMID: 32558913DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sheryl Zimmerman, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 25, 2019

Study Start

January 1, 2013

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share