Clinical trial NCT05688982: MOLAR: Mapping Oral Health and Local Area Resources
Official title: MOLAR: Mapping Oral Health and Local Area Resources
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Diseases
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2023-01-18
Enrollment: 2049
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Linkage to oral health care
timeFrame: Within 12 months of randomization
Secondary outcomes:
measure: Time to completion of dental appointment at the individual level
timeFrame: Within 12 months of randomization
measure: Repeat visits for oral health problems
timeFrame: Within 12 months of randomization
measure: Rate of linkage to oral health care at the neighborhood level
timeFrame: Within 12 months of randomization
measure: Oral health quality of life
timeFrame: Within 12 months of randomization
measure: Return visits
timeFrame: Within 12 months of initial visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: