MOLAR: Mapping Oral Health and Local Area Resources

Dental Diseases Clinical Trial

Official title:

MOLAR: Mapping Oral Health and Local Area Resources

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688982
• Other study ID #: 2022P003224
• Secondary ID: UH3DE031920
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: February 22, 2028

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Margaret Samuels-Kalow
• Phone: 617-726-8340
• Email: msamuels-kalow[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2049
• Est. completion date: February 22, 2028
• Est. primary completion date: February 22, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to oral health care	binary, completion of a dental appointment or not	Within 12 months of randomization
Secondary	Time to completion of dental appointment at the individual level	continuous, days from randomization to completion of dental appointment	Within 12 months of randomization
Secondary	Repeat visits for oral health problems	binary, any return visit or not	Within 12 months of randomization
Secondary	Rate of linkage to oral health care at the neighborhood level	continuous rate, ranges from 0-100	Within 12 months of randomization
Secondary	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
Secondary	Return visits	Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).	Within 12 months of initial visit