MOLAR: Mapping Oral Health and Local Area Resources

Not Applicable

Recruiting

• Conditions: Dental Diseases
• Interventions: Behavioral: General information provision; Behavioral: Geographic information provision; Behavioral: Navigational assistance

• Registration Number: NCT05688982
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (aSDoH) on oral health linkage to care for emergency department patients. Researchers will compare three groups: Patients in Arm A will receive paper handouts with general oral health and aSDoH resources. Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Study Start: 2023-08-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2028-02-22
• Study Completion: 2028-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2049

Inclusion Criteria

• To be eligible to participate in this study, an individual must meet all of the following criteria:

  • No evidence of lack of capacity to provide verbal informed consent (as documented in the chart).
  • Willing to comply with all study procedures and be available by phone for the duration of the study (as reported by the patient)
  • Unmet oral health needs as ascertained by the Hope Home (adult) or Gazzaz (pediatric) questions
  • Adult (age ≥18 years old) ED patient or pediatric ED patient (>1 year of age) presenting with parent or legal guardian. Parent will be the primary study participant but if age > 7 years, the child will provide assent for medical record review.
  • Ability to communicate in English or Spanish (as reported by the patient)
  • Emergency severity index (ESI) 2-5 (as documented in the electronic medical record)
  • Residence within catchment area of 3-hospital region (defined by MGB home hospital catchment area) at initial enrollment (as reported by the patient)
  • Working phone number

Exclusion Criteria

• Patients on involuntary holds (per electronic medical record review)
• Presenting from carceral facilities (per electronic medical record review)
• Presenting for acute mental health care under evaluation for Section 12 (per electronic medical record review)
• Patients presenting for assistance with intimate partner violence (IPV) or care following sexual assault

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A--general information	General information provision	Patients in Arm A will receive paper handouts with general oral health and aSDoH resources
C--geographic information and navigational assistance	Navigational assistance	Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.
C--geographic information and navigational assistance	Geographic information provision	Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.
B--geographic information	Geographic information provision	Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.

Primary Outcome Measures

Name	Time	Method
Linkage to oral health care	Within 12 months of randomization	binary, completion of a dental appointment or not

Secondary Outcome Measures

Name	Time	Method
Rate of linkage to oral health care at the neighborhood level	Within 12 months of randomization	continuous rate, ranges from 0-100
Repeat visits for oral health problems	Within 12 months of randomization	binary, any return visit or not
Time to completion of dental appointment at the individual level	Within 12 months of randomization	continuous, days from randomization to completion of dental appointment
Oral health quality of life	Within 12 months of randomization	Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)
Return visits	Within 12 months of initial visit	Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States