Clinical trial NCT03892200: Oral Hygiene in Assisted Living
Official title: Adapting an Evidence-Based Program That Improves Oral Hygiene and Health for Assisted Living Residents With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Long-Term Care
Keywords: Mouth Care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-03-27
Enrollment: 1780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will modify a program that reduces pneumonia among nursing home residents with dementia, so that it is appropriate for assisted living residents with dementia. The program provides daily mouth care to reduce bacteria in the mouth that lead to aspiration pneumonia. The project will develop methods that can be taught to assisted living providers by community dental hygienists, and that are ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.

Detailed description: It could be said that many dementia care and caregiver support interventions are too limited, focusing solely on psychosocial and behavioral concerns. These issues are important, but so too is the physical health of people with dementia -- especially because they are living longer and require more support with health care and activities of daily living. Just imagine the benefit of a physical health care intervention provided daily.

Case in point: tooth brushing, flossing, and gum and denture care. Many people with dementia resist mouth care - almost 90% in nursing homes, in fact. As a result, only 16% have their teeth brushed regularly, putting them at risk for aspiration pneumonia when they inhale bacteria from their teeth, tongue, and gums. In 2013, the research team submitting this proposal developed one of the two existing dementia-focused mouth care programs for nursing homes -- Mouth Care Without a Battle (MCWB) -- which already has become a standard of nursing home care. MCWB changes caregivers' attitudes and behavior, improves oral health, and in a cluster randomized trial, MCWB provided by nursing assistants reduced pneumonia incidence by 32 percent.

The next frontier is to extend MCWB to assisted living (AL), the primary long-term residential care provider for persons with dementia. There are 30,200 AL communities across the country; 90% of their 835,200 residents have cognitive impairment and 42% have moderate or severe dementia (and on average, five untreated oral health conditions), meaning MCWB has the potential to improve the health and quality of life of more than 350,000 AL residents with dementia annually.

There is a unique and timely opportunity to transform MCWB so it is optimally suitable for AL, given the North Carolina Department of Health and Human Services (DHHS) Special Care Dentistry Program offer of partnership. Consequently, the investigators propose this nested cohort cluster randomized trial that will apply the NIH Stage Model and principles of the Science of Behavior Change (SOBC) to lay the groundwork for a pragmatic trial and real-world implementation of MCWB for AL residents with dementia and their caregivers.

The aims of the proposed project are to refine MCWB (NIH Stage I/Aim 1), and examine research efficacy (NIH Stage II/Aim 2) and real-world efficacy (NIH Stage III/Aim 3), focusing on structural, social, and interpersonal mechanisms as the SOBC target. Aims 2 and 3 will use separate samples of 24 AL communities across the state's ten regions. Within each region, one-half of AL communities will be randomized to treatment (MCWB) and one-half to control, and the oral hygiene of 360 residents with dementia will be assessed through eight months. In Aim 2, a research dental hygienist will train AL staff on MCWB and provide ongoing support; in Aim 3, this responsibility will be transferred to community public health dental hygienists working with the DHHS.

Aim 1. Refine MCWB for implementation in assisted living (AL) communities.

1. Identify stakeholder perspectives. Interview (1) the administrator, health care supervisor, and a personal care aide (PCA) from 20 AL communities across North Carolina who have already been trained in MCWB by community-based public health dental hygienists from the DHHS Special Care Dentistry Program, and (2) the dental hygienists who provided that training, to learn attitudes regarding MCWB as developed for nursing homes, the extent to which care has changed, and recommended modifications to MCWB for AL.
2. Create a one-hour MCWB training video (web and digital versatile disc format) targeted to AL. Modifications include videorecording AL staff providing mouth care to residents with dementia, and interviews with residents and families; AL administrators, supervisors and PCAs; and dental hygienists.

Aim 2. Evaluate research efficacy of the MCWB program, with training and support provided by an experienced research dental hygienist.

1. Evaluate MCWB in terms of (1) the reach of the intervention; (2) effects on mediators/targets of change at the organizational and individual level; (3) outcomes (oral hygiene, pneumonia, hospitalizations); (4) associations between change at the organizational and individual level and outcomes, and also associations with characteristics of the AL community and staff; and (5) attitudes, barriers, and facilitators.
2. Develop a coaching manual for community hygienists to provide training and support to AL staff, reflecting lessons-learned from analyses.

Aim 3. Evaluate real-world efficacy of the MCWB program, transferring responsibility for training and support to community public health dental hygienists, thereby testing efficacy of a nationally generalizable model.

1. Assess dental hygienists' (N=24) self-efficacy to provide training and support at baseline, 4, and 8 months.
2. Evaluate MCWB as per Aim 2a, including examining associations with characteristics of the hygienists.
3. Compare implementation and effectiveness outcomes between research and real-world efficacy.
4. Refine the coaching manual for community dental hygienists to provide training and coaching, reflecting lessons-learned from analyses.

By the conclusion of this project, MCWB will be ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.

Eligibility criteria: Assisted living staff

Inclusion Criteria:

* Are 18 years of age or older
* Able to read and speak English fluently

Exclusion Criteria:

* Do not provide direct care to residents in participating assisted living community

Family members

Inclusion Criteria:

* Are 18 years of age or older
* Able to read and speak English fluently

Exclusion Criteria:

* Family member (resident) did not receive mouth care from AL staff

Public health dental hygienists

Inclusion Criteria:

* Are 18 years of age or older
* Able to read and speak English fluently

Exclusion Criteria:

* Not employed by the NC DHHS Oral Health Section (Criteria to be a public health dental hygienist include five years practice experience and CPR and emergency medical training.)

Residents

Inclusion Criteria:

* Are 18 years of age or older
* Have teeth or have and use a denture
* Have a diagnosis of dementia

Exclusion Criteria:

* Requires antibiotic prophylaxis prior to oral hygiene examination
* Currently on hospice or tube-feeding
* Expected to die or be discharged in the next six months

Primary outcomes:
measure: Change in Plaque Index Score for Long-Term Care (PI-LTC) over time
timeFrame: Baseline and 8 months
measure: Change in Gingival Index Score for Long-Term Care (GI-LTC) over time
timeFrame: Baseline and 8 months
measure: Change in Denture Plaque Index Score (DPI) over time
timeFrame: Baseline and 8 months
Secondary outcomes:
measure: Incidence of pneumonia over time
timeFrame: Collected monthly during eight-month study period
measure: Incidence of hospitalizations over time
timeFrame: Collected monthly during eight-month study period
measure: Staff self-efficacy to provide mouth care
timeFrame: Baseline and 8 months
measure: Dental hygienists self-efficacy to train nursing assistants
timeFrame: Baseline and 8 months
measure: Average number of days mouth care was performed
timeFrame: Collected during the eight month study period
measure: Acceptability of the intervention (AIM) Feasibility of Intervention Measure (FIM)
timeFrame: Baseline and 8 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Baseline and 8 months
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Baseline and 8 months
measure: Texas Christian University Workshop Evaluation (WEVAL)
timeFrame: Baseline
measure: Texas Christian University Workshop Assessment Follow-up (WAFU)
timeFrame: 4 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
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.