Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
Healthy Volunteers
NCT06555029

Oral Health Intervention in Adult Primary Care

Led by Case Western Reserve University · Updated on 2025-10-15

929

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

C

Case Western Reserve University

Lead Sponsor

N

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oral Health Intervention in Adult Primary Care

Who Can Participate

Age: 55Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Practices must use Epic EHR
  • Practices must have older adults covered by Medicaid
  • Practices must be located within 60 miles of the CWRU research offices
  • Medical staff (MA, nurse) must not float between practices
  • Medical staff must plan to stay at the practice for at least one year
  • Medical staff must provide signed and dated consent
  • Clinicians (Physician, Nurse Practitioner) must have at least 2 patient-care days per week
  • Clinicians must not float between practices
  • Clinicians must plan to stay at the practice for at least one year
  • Clinicians must provide signed and dated consent
  • Older adults must be enrolled in CareSource Medicaid Plan
  • Older adults must be aged 55 years or older
  • Older adults must attend non-urgent primary care visits at an enrolled site
  • Older adults must provide signed and dated informed consent
  • Older adults must plan to stay in the immediate area for the next year
  • Older adults must be enrolled in the Adult Wellness Registry
Not Eligible

You will not qualify if you...

  • Presence of any serious medical condition such as dementia or other cognitive disorder preventing participation, as indicated by clinician
  • Presence of serious mental health disorders such as schizophrenia preventing participation, as indicated by clinician

AI-Screening

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Trial Site Locations

Total: 1 location

1

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

S

Suchitra Nelson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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