Oral Health Intervention in Adult Primary Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorCase Western Reserve University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Use Epic EHR

Have older adults covered by Medicaid

Located within 60 miles of the CWRU research offices

Do not float between practices

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

  • 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.

Treatment groups

929 Participants
are divided into 2 treatment groups
Group A: Arm A: EHR Changes, EHR Training, and CSM theory-based Oral Health TrainingExperimental treatment 2 interventions
Group B: Arm B: Control Arm with Standard ADA Oral Health TrainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Data will be abstracted from Medicaid Claims data from baseline PCV #1 to 24 month exit visit (PCV #3)
2

Dental visits

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

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

Secondary outcomes

1

Change in oral hygiene

Frequency of tooth brushing

Time frame
Assessed as change between baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV#3)
2

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.

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

Change in Biometric Measures-Blood Pressure

Systolic and diastolic blood pressure in mmHg

Time frame
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)
4

Change in Biometric Measures-BMI

Weight (lbs) and height (inches) will be converted to kg and meters to calculate BMI in kg/m\^2

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Western Reserve University

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator