MOLAR: Mapping Oral Health and Local Area Resources

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Diseases
• Intervention / Treatment: Behavioral: General information provision; Behavioral: Geographic information provision; Behavioral: Navigational assistance

• Study Type: Interventional
• Enrollment (Estimated): 2049
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret Samuels-Kalow; Phone Number: 617-726-8340; Email: msamuels-kalow@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Margaret Samuels-Kalow, MD MSHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A--general information; Patients in Arm A will receive paper handouts with general oral health and aSDoH resources	Behavioral: General information provision; Patients will receive information with general oral health and aSDoH resources.
Other: B--geographic information; Patients in Arm B will receive paper handouts with geographically-proximate 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.
Other: C--geographic information and navigational assistance; Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.	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.

What is the study measuring?

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
Return visits	Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).	Within 12 months of initial visit
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): February 22, 2028
• Study Completion (Estimated): February 22, 2028

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: 2022P003224; UH3DE031920 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Due to the sensitive nature of the database (including information about potential stigmatizing factors including social risk and need), access to scientific data will be controlled and provided under a restricted data contract to users who demonstrate a valid research need and meet conditions of use. Scientific Data derived from humans will be protected through de-identification, removal of information that may be used to infer the identity of individuals and shared under controlled-access conditions as required by institutional policy.
• IPD Sharing Time Frame: Data will be made available as soon as possible or at the time of associated publication, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No