AgingNCT03817450
Daily Mouth Care to Prevent Pneumonia in Nursing Homes
A study testing Daily Mouth Care in people with Aging and Nursing Home, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aging, Nursing Home, Pneumonia
- What is being tested?
- Daily Mouth Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,416 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach
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.
Read the 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.
- 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.
- 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
- Being tested
- Daily Mouth Care
- Keywords
- Mouth Care
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Mouth CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumonia over time
The total number of diagnosed cases of pneumonia
Measured: Collected every four months during the 2 year study
Secondary outcomes (5)
Incidence of hospitalizations over time
The total number of hospitalizations
Measured: Collected every four months during the 2 year study
Mortality
The total number of deaths that occur in the nursing home
Measured: Collected every four months during the 2 year study
Staff self-efficacy to provide mouth care
The measure will be administered to all CNAs (age 21 and older) in the intervention sites at baseline and 24 months, and to all CNAs (age 21 and older) in the control sites at 24 months (to avoid a possible Hawthorne effect from pre-administration). In the intervention sites, the 24-month measure will include a retrospective pre-test that asks respondents to reflect on their initial self-efficacy after having learned what they might not have known that they did not know previously. The self-efficacy measure has 35 items (Cronbach's alpha α=0.74-0.92), scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to provide mouth care.
Measured: Baseline and 24 months
Frequency of mouth care
Daily mouth care will be documented on a simple log developed for the MCWB pilot study, on which the certified nursing assistant will record daily, for each resident, whether mouth care occurred. If mouth care did not occur, a reason is documented.
Measured: Collected during the entire 2 year study
Number of times mouth care products were used
Use of mouth care products will be will be documented whenever a certified nursing assistant indicates on the mouth care log that mouth care was provided.
Measured: Collected during the entire 2 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startJan 2013
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheryl Zimmerman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817450
- Sponsor's protocol ID
- 13-2072
- Other IDs
- 4R01HS022298-03
- Status last verified
- Nov 2019
- First submitted
- 23 Jan 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36383760Zimmerman 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.
PubMed 32558913
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach
- ClinicalTrials.gov ID
- NCT03817450
- Acronym / sponsor ID
- 13-2072
- Conditions
- Aging, Nursing Home, Pneumonia
- Keywords
- Mouth Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Mouth Care | Experimental | Behavioral: Daily Mouth CareThe 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Mouth CareNursing 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. | Behavioural | Daily Mouth Care |
Primary outcome
Incidence of pneumonia over time
Time frame: Collected every four months during the 2 year study
The total number of diagnosed cases of pneumonia
5 secondary outcomes
Incidence of hospitalizations over time
Time frame: Collected every four months during the 2 year study
Mortality
Time frame: Collected every four months during the 2 year study
Staff self-efficacy to provide mouth care
Time frame: Baseline and 24 months
Frequency of mouth care
Time frame: Collected during the entire 2 year study
Number of times mouth care products were used
Time frame: Collected during the entire 2 year study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 36383760Cao 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.
- Derived from this study: PubMed 32558913Zimmerman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Zimmerman, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Daily Mouth Care in people with Aging and Nursing Home, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia over time (time frame: Collected every four months during the 2 year study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817450, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.