NCT06555029 Oral Health Intervention in Adult Primary Care
| NCT ID | NCT06555029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 929 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 929 participants in total. It began in 2024-09-25 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Suchitra Nelson, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT06555029 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06555029 currently recruiting?
Yes, NCT06555029 is actively recruiting participants. Contact the research team at sxn15@case.edu for enrollment information.
Where is the NCT06555029 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06555029 clinical trial?
NCT06555029 is sponsored by Case Western Reserve University. The principal investigator is Suchitra Nelson, PhD at Case Western Reserve University. The trial plans to enroll 929 participants.