MOLAR: Mapping Oral Health and Local Area Resources

Study Overview
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Brief Summary
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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.

Official Title
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MOLAR: Mapping Oral Health and Local Area Resources

Conditions
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Dental Diseases

Intervention / Treatment
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* Behavioral: General information provision
* Behavioral: Geographic information provision
* Behavioral: Navigational assistance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A--general information<br>Patients in Arm A will receive paper handouts with general oral health and aSDoH resources | Behavioral: General information provision<br>* Patients will receive information with general oral health and aSDoH resources.<br>|
| Other: B--geographic information<br>Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. | Behavioral: Geographic information provision<br>* Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.<br>|
| Other: C--geographic information and navigational assistance<br>Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance. | Behavioral: Geographic information provision<br>* Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.<br>Behavioral: Navigational assistance<br>* Patients will receive phone-based navigational assistance from the study navigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to oral health care | binary, completion of a dental appointment or not | Within 12 months of randomization | 

Secondary Outcome Measures

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