Recruiting

Oral Health Intervention

Sponsor:

Case Western Reserve University

Code:

NCT06555029

Conditions

Dental Caries

Dry Mouth

Periodontal Diseases

Bleeding Gum

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

EHR Changes

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

Standard ADA Oral Health Training

Study Details

Brief 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

Study ID

NCT06555029

Start date

Sep 25, 2024

Status verified date

Oct, 2025

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

929 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm A: EHR Changes, EHR Training, and CSM theory-based Oral Health Training

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

active comparator: Arm B: Control Arm with Standard ADA Oral Health Training

ADA-based education for clinicians only

Interventions

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

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.

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.

Primary outcome measure

  • Dental Attendance [ Time Frame: Data will be abstracted from Medicaid Claims data from baseline PCV #1 to 24 month exit visit (PCV #3) ]
  • Dental visits [ Time Frame: Data will be abstracted from dental EHR from baseline PCV#1 to 24 month exit visit (PCV #3) ]

Central Contacts and Locations

Central contacts

Suchitra Nelson, PhD

216-368-3469sxn15@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Suchitra Nelson

suchitra.nelson@case.edu

David Kaelber

dkaelber@metrohealth.org

Principal Investigator:

Suchitra Nelson, PhD

More Information

Sponsor

Case Western Reserve University

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • Oral Health
  • Primary Care
  • Older Adults
  • Common Sense Model of Self-Regulation
  • EHR Modifications (Oral Health Questions and Referral)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2025-10-15.