Oral Health Intervention in Adult Primary Care

NCT06555029 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 929

Last updated 2025-10-15

No results posted yet for this study

Summary

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

  • Dental Caries
  • Dry Mouth
  • Periodontal Diseases
  • Bleeding Gum

Interventions

BEHAVIORAL

EHR Changes

Practice-Level: Changes to the Epic EHR system will include the AAAC process to ask 5 oral health questions, advise for dental attendance, assess the type of referral, and connect with referral and resources

BEHAVIORAL

Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training

Provider-Level: Medical staff to complete EHR training and then deliver the ask, advise, assess, connect (AAAC) strategies to screen, refer, and provide resources for oral health. Clinician will receive Common-Sense Model of Self- Regulation (CSM) and Social Cognitive Theory based education and skills training for the physician/nurse practitioner to communicate core OH facts to the patient and provide reinforcement of the importance of dental visits to overall health. Clinicians will also document the encounter in EHR.

BEHAVIORAL

Standard ADA Oral Health Training

Provider-Level: Clinician only: Clinicians will receive standard American Dental Association (ADA) based oral health hygiene training (brushing, flossing, fluoridated water, cleaning dentures) and asked to follow their current oral health care with their patients. The usual care currently is to address oral health issues if the patient complains or has a question. The clinicians will not have skills training nor visual resources for the patient encounter.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH
  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Suchitra Nelson, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2028-10-30
Completion
2028-10-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06555029 on ClinicalTrials.gov