RECRUITING

Oral Health Intervention in Adult Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multi-Level Interventions to Reduce Oral Health Disparities Among Adults in Primary Care Settings

Quick Facts

Study Start:2024-09-25
Study Completion:2028-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Use Epic EHR
  2. * Have older adults covered by Medicaid
  3. * Located within 60 miles of the CWRU research offices
  4. * Do not float between practices
  5. * Plan not to leave practice within a year
  6. * Provide a signed and dated consent form
  7. * Have a minimum of 2 patient-care days per week
  8. * Do not float between practices
  9. * Plan not to leave practice within a year
  10. * Provide signed and dated consent form
  11. * Enrolled in CareSource Medicaid Plan
  12. * Female or male aged 55 years or older
  13. * Attending non-urgent primary care visits (PCV) at enrolled site
  14. * Provide signed and dated informed consent form
  15. * Planning to stay in the immediate area for the next year
  16. * Enrolled in the Adult Wellness Registry
  1. * 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.
  2. * The presence of any serious mental health disorders such as schizophrenia where the clinician indicates they should not participate.

Contacts and Locations

Study Contact

Suchitra Nelson, PhD
CONTACT
216-368-3469
sxn15@case.edu

Principal Investigator

Suchitra Nelson, PhD
PRINCIPAL_INVESTIGATOR
Case Western Reserve University

Study Locations (Sites)

Case Western Reserve University
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

  • Suchitra Nelson, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25
Study Completion Date2028-10-30

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2028-10-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Dental Caries
  • Dry Mouth
  • Periodontal Diseases
  • Bleeding Gum