Oral Health Intervention in Adult Primary Care
NCT Number: NCT06555029
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries|Dry Mouth|Periodontal Diseases|Bleeding Gum
Interventions: BEHAVIORAL: EHR Changes|BEHAVIORAL: Medical Staff EHR Training, Clinician CSM theory-based didactic education and skills training|BEHAVIORAL: Standard ADA Oral Health Training
Sponsor: Case Western Reserve University
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 929
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-09-16
Completion Date: 2028-10-30
Locations: Case Western Reserve University, Cleveland, Ohio, 44106, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Change in oral hygiene, Frequency of tooth brushing, 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, Total numeric score on Geriatric Oral Health Quality of Life 12-item questionnaire. Scale is a Likert-scale. Total scores range from 12 as the lowest to 60 being the highest score. Higher scores indicate a higher 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, Systolic and diastolic blood pressure in mmHg, 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, Weight (lbs) and height (inches) will be converted to kg and meters to calculate BMI in kg/m\^2, 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, Blood glucose in mg/dl, 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 -serum cholesterol, Serum cholesterol in mg/dl, 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 -Hemoglobin A1C, HbA1c as a percent (%), 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)