MOLAR: Mapping Oral Health and Local Area Resources

Overview

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.

Interventions

• Behavioral General information provision
  Patients will receive information with general oral health and aSDoH resources.
• Behavioral Geographic information provision
  Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
• Behavioral Navigational assistance
  Patients will receive phone-based navigational assistance from the study navigator.

Primary outcome measures

• Linkage to oral health care [Time frame: Within 12 months of randomization]

Secondary outcome measures (5)

• Time to completion of dental appointment at the individual level [Time frame: Within 12 months of randomization]
• Repeat visits for oral health problems [Time frame: Within 12 months of randomization]
• Rate of linkage to oral health care at the neighborhood level [Time frame: Within 12 months of randomization]
• Oral health quality of life [Time frame: Within 12 months of randomization]
• Return visits [Time frame: Within 12 months of initial visit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Publications

• Simon L, Marsh R, Sanchez LD, Camargo C, Donoff B, Cardenas V, Manning W, Loo S, Cash RE, Samuels-Kalow ME. Mapping Oral health and Local Area Resources (MOLAR): protocol for a randomised controlled trial connecting emergency department patients with social and dental resources. BMJ Open. 2023 Dec 10;13(12):e078157. doi: 10.1136/bmjopen-2023-078157. PMID 38072485

Identifiers

NCT: NCT05688982 · 2022P003224 · UH3DE031920

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗