MOLAR: Mapping Oral Health and Local Area Resources

Mass General Brigham

Status: Enrolling

Conditions: Dental Diseases

Treatments: Behavioral: Navigational assistance; Behavioral: General information provision; Behavioral: Geographic information provision

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05688982

UH3DE031920 (U.S. NIH Grant/Contract)

2022P003224

Details and patient eligibility

About

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.

Enrollment: 2,049 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,049 participants in 3 patient groups

A--general information

Other group

Description:

Patients in Arm A will receive paper handouts with general oral health and aSDoH resources

Treatment:

Behavioral: General information provision

B--geographic information

Other group

Description:

Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.

Treatment:

Behavioral: Geographic information provision

C--geographic information and navigational assistance

Other group

Description:

Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

Treatment:

Behavioral: Geographic information provision

Behavioral: Navigational assistance