Oral Health Intervention in Adult Primary Care

NCT06555029 | Recruiting

• 2 other identifiers: STUDY000006024UH3DE030856-03
• Study Type: interventional
• Target: 929
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Dental Attendance

  Receipt of dental care as number of visits through Medicaid Claims data (Current Dental Terminology (CDT) codes for preventive or restorative procedures in the past 12 months).

  Data will be abstracted from Medicaid Claims data from baseline PCV #1 to 24 month exit visit (PCV #3)

• Dental visits

  Receipt of preventive and restorative dental care as number of visits through dental EHR data

  Data will be abstracted from dental EHR from baseline PCV#1 to 24 month exit visit (PCV #3)

Secondary Outcomes (7)

• Change in oral hygiene

  Assessed as change between baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV#3)

• Change in Oral Health Quality of Life

  Assessed as change between baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV#3)

• Change in Biometric Measures-Blood Pressure

  Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3)

• Change in Biometric Measures-BMI

  Data will be abstracted from Epic EHR to assess BMI changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3)

• Change in Biometric Measures -blood glucose

  Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3)

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: EHR Changes; Behavioral: Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training

Arm B: Control Arm with Standard ADA Oral Health Training

ACTIVE COMPARATOR

ADA-based education for clinicians only

Behavioral: Standard ADA Oral Health Training

Interventions

EHR Changes BEHAVIORAL

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

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

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

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.

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

Standard ADA Oral Health Training BEHAVIORAL

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.

Arm B: Control Arm with Standard ADA Oral Health Training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries; Xerostomia; Periodontal Diseases; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Mouth Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suchitra Nelson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchitra Nelson, PhD

CONTACT

216-368-3469; sxn15@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean and Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 15, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)