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Oral Health Intervention in Adult Primary Care

Case Western Reserve University · with National Institute of Dental and Craniofacial Research (NIDCR) · NCT06555029

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
929
US sites recruiting
1
Study start
September 25, 2024
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: EHR Changes; Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training; Standard ADA Oral Health Training

Conditions: Dental Caries; Dry Mouth; Periodontal Diseases; Bleeding Gum

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Practices

  • Use Epic EHR
  • Have older adults covered by Medicaid
  • Located within 60 miles of the CWRU research offices

Provider (medical staff or clinician):

Medical staff (MA, nurse):

  • Do not float between practices
  • Plan not to leave practice within a year
  • Provide a signed and dated consent form

Clinicians (Physician, NP):

  • Have a minimum of 2 patient-care days per week
  • Do not float between practices
  • Plan not to leave practice within a year
  • Provide signed and dated consent form

Older Adult/Patient Participant

  • Enrolled in CareSource Medicaid Plan
  • Female or male aged 55 years or older
  • Attending non-urgent primary care visits (PCV) at enrolled site
  • Provide signed and dated informed consent form
  • Planning to stay in the immediate area for the next year
  • Enrolled in the Adult Wellness Registry

Exclusion Criteria

  • The 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.
  • The presence of any serious mental health disorders such as schizophrenia where the clinician indicates they should not participate.

Recruiting US locations

  • Case Western Reserve University

    Cleveland, OH 44106

    Site contact: Suchitra Nelson · suchitra.nelson@case.edu

Study contacts (from the official record)

  • Suchitra Nelson, PhD · 216-368-3469 · sxn15@case.edu
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Oral Health Intervention in Adult Primary Care (NCT06555029) | Bored Studies