Oral Health Interventions for Older Adults

Overseen By Suchitra Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Dementia, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

929 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on oral health interventions and does not mention medication changes.

What data supports the effectiveness of the treatment Oral Health Intervention, Dental Care Intervention, Oral Health Education for older adults?

Research shows that oral health education and interventions can significantly improve the oral health of older adults, especially in settings like nursing homes. These interventions help maintain better oral hygiene and improve the quality of life for older people. ^{1 2 3 4 5}

Is the Oral Health Intervention generally safe for older adults?

Research shows that adverse events in dental care are rare and mostly preventable, with incidents often related to clinical management, laboratory quality, and documentation errors. While some serious incidents have occurred, they are infrequent, and most result in no or low harm, indicating that oral health interventions are generally safe. ^{6 7 8 9 10}

How is the Oral Health Intervention treatment for older adults different from other treatments?

The Oral Health Intervention for older adults is unique because it focuses on education and community-based approaches to improve oral health, rather than just clinical treatments. This approach aims to empower individuals with knowledge and skills to maintain their oral health in their everyday environments, which can lead to more sustainable improvements compared to traditional clinical settings. ^{1 3 4 11 12}

What is the purpose of this trial?

This study is a Stage III cRCT to test the efficacy of multi-level interventions at the practice- and provider-level to address low dental utilization (attendance) among Medicaid-enrolled older adults 55 years or older attending non-urgent primary care visits (PCV) in MetroHealth practice settings. Twelve practices will be randomized into two arms: A) Intervention arm will receive the multi-level intervention that includes: 1. Practice-level: EHR changes to include: ask, advise, assess, and connect (AAAC) strategies; 2. Provider-level: Medical staff (MA, nurse): Training in the AAAC process and complete AAAC for enrolled older adults; Clinicians (physician/nurse practitioner): CSM-based education (didactic), skills training (video training with standardized patients), and view completed AAAC in EHR to deliver core oral health (OH) facts to older adults, reinforce importance of dental visits, and document in EHR that OH facts were delivered. B) Control arm will receive, at the provider-level only (clinicians), non-theory-based information about retaining a healthy mouth using the ADA Mouth Healthy Series and deliver standard OH care for patients. Older Adults will be followed at 12 months and 24 months to determine if the participant had any dental attendance. The primary objective is to test the efficacy of the practice level EHR strategy to ask \[OH risk assessment\], advise \[going to dentist\], assess \[willingness for referral\], and connect \[eReferral, resources\] together with clinician theory-based education to communicate OH facts versus clinician alone (standard oral health care) in increasing dental attendance in primary care settings. The secondary objectives are to assess oral hygiene behavior, Geriatric Oral Health Quality of life, biometric measures (BP, serum cholesterol, blood glucose, hbA1c) abstracted from EHR data, potential mediators and moderators to investigate pathways that affect the primary and secondary outcomes, and assess implementation strategies: adoption, reach, fidelity, and maintenance of providers and practices that affect older adult primary and secondary outcomes. The hypothesis is that medical staff completing the AAAC strategy and clinicians with improved OH knowledge (chronicity, systemic effects) will deliver consistent oral health messaging to older adults at PCVs that will result in increased preventive and restorative dental utilization compared to those providers delivering standard care.

Research Team

Suchitra Nelson, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for Medicaid-enrolled adults aged 55 or older who visit MetroHealth practices for non-urgent care and have low dental attendance. It aims to improve their oral health by testing new interventions.

Inclusion Criteria

Medical staff (MA, nurse) do not float between practices

Clinicians (Physician, NP) plan not to leave practice within a year

I am 55 years old or older.

Exclusion Criteria

Presence of any serious mental health disorders such as schizophrenia where the clinician indicates they should not participate

Presence of any serious medical health condition (such as dementia or other cognitive disorder not allowing them to participate) where the clinician indicates they should not participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Medical staff and clinicians receive training on EHR changes and oral health communication strategies

4-6 weeks

1-2 visits (in-person)

Intervention

Implementation of multi-level interventions including EHR changes and oral health communication during primary care visits

24 months

3 primary care visits (in-person)

Follow-up

Participants are monitored for dental attendance and changes in oral health quality of life and biometric measures

24 months

Follow-up assessments at each primary care visit

Treatment Details

Interventions

• Oral Health Intervention

Trial Overview The study tests a multi-level intervention against standard care. One group's EHR will prompt staff to discuss oral health (OH) risks, while clinicians receive special training on OH facts. The other group gets basic OH info without the EHR prompts.

Participant Groups

Group I: Arm A: EHR Changes, EHR Training, and CSM theory-based Oral Health Training Experimental Treatment 2 Interventions

AAAC EHR Changes, Medical staff EHR Training, Clinician CSM theory based education and skills training

Group II: Arm B: Control Arm with Standard ADA Oral Health Training Active Control 1 Intervention

ADA-based education for clinicians only

Oral Health Intervention is already approved in United States for the following indications:

Approved in United States as Oral Health Intervention for:

• Improving dental utilization among Medicaid-enrolled older adults

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Findings from Research

A scoping review of 81 studies on oral health interventions for people over 65 found that most interventions (64 out of 81) showed statistically significant benefits, indicating that various approaches can effectively improve oral health in older adults.

The majority of research focuses on primary prevention at the patient/carer level, highlighting a need for more studies targeting secondary prevention at the dentist level, using standardized outcome measures to enhance comparability and robustness of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve oral health of older people: A scoping review. Gomez-Rossi, J., Hertrampf, K., Abraham, J., et al.[2021]

A new oral healthcare educational program involving weekly guidance from dental hygienists led to significant improvements in dental plaque levels among nursing home residents over a 3-month period, indicating enhanced oral health.

The intervention also increased nursing staff awareness of their limitations in oral health care and highlighted the importance of regular contact with dental services, suggesting that hands-on training may be more effective than traditional education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical and hands-on guidance from dental hygienists promotes good oral health in elderly people living in nursing homes, a pilot study. Seleskog, B., Lindqvist, L., Wårdh, I., et al.[2019]

The scoping review identified various interventions aimed at improving the oral health of older adults, highlighting the need for tailored approaches to address their specific dental care challenges.

The review emphasizes the importance of integrating oral health strategies into broader healthcare practices for older individuals to enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Settings-based Interventions at Primary, Secondary and Tertiary Prevention Levels May Significantly Improve the Oral Health of Older People. Hegde, S.[2021]

Educational interventions aimed at improving oral health among older adults have been shown to be effective, as evidenced by a review of 23 studies, including 17 randomized controlled trials.

The review highlights the need for higher quality studies to further assess the effectiveness of these interventions, as many of the included studies were of moderate quality and varied in their approaches, with lectures being the most common method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health education interventions on oral health promotion among older people: a systematic review. Bashirian, S., Khoshravesh, S., Ayubi, E., et al.[2023]

A systematic review of 20 studies found that effective implementation strategies for improving oral health care in older adults in long-term care facilities often focus on enhancing knowledge, self-efficacy, and facilitating behavior change, primarily delivered by dental professionals and executed by nursing staff.

While strategies that increase knowledge and self-efficacy were successful, the overall quality and variability of the studies make it difficult to recommend specific strategies universally; care professionals should customize their approaches based on the specific needs and barriers of their target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral health care in older people in long term care facilities: a systematic review of implementation strategies. Weening-Verbree, L., Huisman-de Waal, G., van Dusseldorp, L., et al.[2022]

Approximately 3.4% of older adults visiting the dentist are prescribed drugs that could lead to serious drug interactions, highlighting a significant safety concern for dental practitioners.

Commonly prescribed drugs in dentistry that pose serious interaction risks include benzodiazepines, macrolide antibiotics, and nonsteroidal anti-inflammatory analgesics, emphasizing the need for careful management of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious drug-drug interactions among community-dwelling older adult dental patients. Skaar, DD., O'Connor, H.[2022]

Out of 16,060 patients treated at the School of Dentistry, only 0.26% (43 patients) reported adverse events, highlighting that such incidents are relatively rare but still significant.

A striking 97.7% of these adverse events were deemed preventable, with the majority occurring during clinical treatments by postgraduate students, indicating a need for improved training and safety protocols in dental education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia. Huertas, MF., Gonzalez, J., Camacho, S., et al.[2018]

In a review of 1000 patient records from 20 dental practices over 60 months, only 46 adverse events (AEs) were identified, indicating a low incidence of safety incidents in primary oral healthcare.

Of the AEs, 18 were deemed preventable, primarily related to treatment and diagnostics, suggesting that while primary oral care is generally safe, there is room for improvement in record keeping and incident prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in dental care: A challenging quality issue? An exploratory cohort study. Mettes, T., Bruers, J., van der Sanden, W., et al.[2013]

Over a six-year period, 287 adverse incidents were reported at a dental teaching hospital, representing only 0.039% of outpatient or day surgery appointments, indicating that while incidents do occur, they are relatively rare.

The majority of incidents (72%) happened during treatment or cleanup, with the most common issues arising from local anesthetic administration and dental handpiece burs, highlighting specific areas where safety protocols can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse incidents resulting in exposure to body fluids at a UK dental teaching hospital over a 6-year period. Hughes, A., Davies, L., Hale, R., et al.[2021]

Between 2005 and 2014, there were 32,263 reported patient safety events in dentistry in England, with 43 classified as never events, primarily involving wrong site extractions, which often resulted in no harm or low harm.

Serious harm and death risks were notably higher in older patients (over 67 years) with medical complexities, particularly in acute trust wards and during oral surgery, highlighting the need for improved reporting and training to enhance patient safety in dental practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of never and serious events related to dentistry 2005-2014. Renton, T., Sabbah, W.[2018]

As the elderly population retains more natural teeth and may use implants, maintaining oral health becomes increasingly important, necessitating more demanding oral self-care routines.

Effective strategies for preventing oral disease in the elderly include promoting overall health, educating through dental hygienists, using fluoride toothpaste, and providing regular professional support, especially for those who are less well or confused.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of oral hygiene programmes for elderly people--a review. de Baat, C., Kalk, W., Schuil, GR.[2019]

A 5-year community-based trial is being conducted to improve oral health among low-income older adults through a dual intervention approach that includes face-to-face counseling and resident-run oral health campaigns, involving 360 participants living in subsidized housing.

The study aims to assess the effectiveness of these interventions on oral health outcomes, such as plaque score and gingival index, and is designed to explore the sustainability of the interventions, potentially allowing for broader implementation in similar communities if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health). Schensul, J., Reisine, S., Grady, J., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Interventions to improve oral health of older people: A scoping review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Theoretical and hands-on guidance from dental hygienists promotes good oral health in elderly people living in nursing homes, a pilot study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Settings-based Interventions at Primary, Secondary and Tertiary Prevention Levels May Significantly Improve the Oral Health of Older People. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The impact of health education interventions on oral health promotion among older people: a systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Oral health care in older people in long term care facilities: a systematic review of implementation strategies. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Potentially serious drug-drug interactions among community-dwelling older adult dental patients. [2022]

7. Argentina pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Patient safety in dental care: A challenging quality issue? An exploratory cohort study. [2013]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse incidents resulting in exposure to body fluids at a UK dental teaching hospital over a 6-year period. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Review of never and serious events related to dentistry 2005-2014. [2018]

11. England pubmed.ncbi.nlm.nih.gov

The effectiveness of oral hygiene programmes for elderly people--a review. [2019]

12. Canada pubmed.ncbi.nlm.nih.gov

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health). [2020]