Oral Hygiene in Assisted Living

Aging Clinical Trial

Official title:

Adapting an Evidence-Based Program That Improves Oral Hygiene and Health for Assisted Living Residents With Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892200
• Other study ID #: 18-2795
• Secondary ID: R01AG061966
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Lynne A Sampson, PhD, MPH
• Phone: 919-966-7543
• Email: LSampson[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1780
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Long-Term Care

Intervention

Behavioral:
• 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 assisted living communities.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plaque Index Score for Long-Term Care (PI-LTC) over time	The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.	Baseline and 8 months
Primary	Change in Gingival Index Score for Long-Term Care (GI-LTC) over time	The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Buccal and lingual surfaces scores also are calculated. Lower scores are better.	Baseline and 8 months
Primary	Change in Denture Plaque Index Score (DPI) over time	The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.	Baseline and 8 months
Secondary	Incidence of pneumonia over time	The total number of diagnosed cases of pneumonia	Collected monthly during eight-month study period
Secondary	Incidence of hospitalizations over time	The total number of hospitalizations	Collected monthly during eight-month study period
Secondary	Staff self-efficacy to provide mouth care	The measure will be administered to all nursing assistants in the intervention sites at baseline and 8 months, and to all nursing assistants in the control sites at 8 months (to avoid a possible Hawthorne effect from pre-administration). In the intervention sites, the 8-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 categories, scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to provide mouth care.	Baseline and 8 months
Secondary	Dental hygienists self-efficacy to train nursing assistants	The measure will be administered to all dental hygienists in the study at baseline and 8 months. The 8-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 categories, scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to train nursing assistants.	Baseline and 8 months
Secondary	Average number of days mouth care was performed	Daily mouth care will be documented on a simple log developed for the MCWB pilot study, on which the nursing assistant will record daily, for each resident, whether mouth care occurred. If mouth care did not occur, a reason is documented.	Collected during the eight month study period
Secondary	Acceptability of the intervention (AIM) Feasibility of Intervention Measure (FIM)	The AIM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is acceptable. The AIM has four items rated on a five-point Likert scale. Higher scores show more acceptability of the intervention.	Baseline and 8 months
Secondary	Intervention Appropriateness Measure (IAM)	The IAM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is appropriate. The IAM has four items rated on a five-point Likert scale. Higher scores show more appropriateness of the intervention.	Baseline and 8 months
Secondary	Feasibility of Intervention Measure (FIM)	The FIM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is feasible. The FIM has four items rated on a five-point Likert scale. Higher scores show more feasibility of the intervention.	Baseline and 8 months
Secondary	Texas Christian University Workshop Evaluation (WEVAL)	The Texas Christian University Workshop Evaluation (WEVAL) 22-item Likert measure assesses utilization (e.g., "you used similar materials in the past with little success"), resources (e.g., "you have enough staff to implement the procedures"), training (e.g., "you would attend follow-up training"), and support (e.g., "your director would support and encourage use"). Lower scores mean less barriers to implementation.	Baseline
Secondary	Texas Christian University Workshop Assessment Follow-up (WAFU)	The Texas Christian University Workshop Assessment Follow-Up (WAFU) is a 14-item Likert measure with subscales related to training satisfaction (e.g., "do you expect to use these materials") and implementation barriers. Eight barriers are provided, related to resources (e.g., "lack of time") and procedures (e.g., "doesn't fit my style"); other barriers are queried. The form will be modified so the wording is consistent with MCWB, and to solicit suggestions as to how to overcome the barriers, as well as what facilitated implementation. Lower scores mean less barriers to implementation.	4 months