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NCT06555029 · ClinicalTrials.gov registry record · NA

Oral Health Intervention in Adult Primary Care

A NA study of Dental Caries and Periodontal Diseases, sponsored by Case Western Reserve University.

Recruiting
Registry status
NA
Development phase
929
Enrollment target
1
Study location

NCT06555029 is a NA study of Dental Caries and Periodontal Diseases that is actively recruiting participants, run by Case Western Reserve University. The registered enrollment target is 929 participants, above the 691-participant average among 30 other Dental Caries trials with a reported enrollment target (34% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06555029, a NA study of Dental Caries and Periodontal Diseases, is actively recruiting participants, sponsored by Case Western Reserve University.

RECRUITING
Registry status
NA
Development phase
929 participants
Enrollment target
1
Study location

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 implementatio

Interventions

  • BEHAVIORAL EHR Changes
  • BEHAVIORAL Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training
  • BEHAVIORAL Standard ADA Oral Health Training

Study Locations (1)

Ohio

  • Case Western Reserve University - Cleveland

Trial Details

FieldValue
Enrollment Target 929 participants
Start Date 2024-09-25
Est. Completion 2028-10-30
Phase NA

Sponsor

Case Western Reserve University

141 total trials

What the Registry Record Tells You About NCT06555029

The ClinicalTrials.gov registry entry for NCT06555029 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 929 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 691-participant average among 30 other Dental Caries trials with a reported enrollment target (34% higher). The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Dental Caries appearing as the primary indexed condition, and to 3 interventions - of which EHR Changes is the first listed.

NCT06555029 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT06555029 about?

NCT06555029 is a clinical study titled "Oral Health Intervention in Adult Primary Care". 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. ...

What is the current status of trial NCT06555029?

This trial is currently recruiting. It is a NA study. The enrollment target is 929 participants. The study started on 2024-09-25. Estimated completion is 2028-10-30.

What conditions does trial NCT06555029 study?

This clinical trial studies the following conditions: Dental Caries, Periodontal Diseases, Dry Mouth, Bleeding Gum.

What interventions are being tested in trial NCT06555029?

The interventions under investigation include: EHR Changes (BEHAVIORAL), Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training (BEHAVIORAL), Standard ADA Oral Health Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT06555029?

This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06555029 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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