MOLAR: Mapping Oral Health and Local Area Resources

NCT05688982 | Recruiting DMC

• 2 other identifiers: 2022P003224UH3DE031920
• Study Type: interventional
• Target: 2,927
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Diseases

Outcome Measures

Primary Outcomes (1)

• Linkage to oral health care

  binary, completion of a dental appointment or not

  Within 12 months of randomization

Secondary Outcomes (5)

• Time to completion of dental appointment at the individual level

  Within 12 months of randomization

• Repeat visits for oral health problems

  Within 12 months of randomization

• Rate of linkage to oral health care at the neighborhood level

  Within 12 months of randomization

• Oral health quality of life

  Within 12 months of randomization

• Return visits

  Within 12 months of initial visit

Study Arms (3)

A--general information

OTHER

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

Behavioral: General information provision

B--geographic information

OTHER

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

Behavioral: Geographic information provision

C--geographic information and navigational assistance

OTHER

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

Behavioral: Geographic information provision; Behavioral: Navigational assistance

Interventions

General information provision BEHAVIORAL

Patients will receive information with general oral health and aSDoH resources.

A--general information

Geographic information provision BEHAVIORAL

Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.

B--geographic information; C--geographic information and navigational assistance

Navigational assistance BEHAVIORAL

Patients will receive phone-based navigational assistance from the study navigator.

C--geographic information and navigational assistance

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stomatognathic Diseases

Central Study Contacts

Margaret Samuels-Kalow

CONTACT

617-726-8340; msamuels-kalow@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): February 22, 2028
• Study Completion (Estimated): February 22, 2028
• Last Updated: April 9, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

US (1)