MOLAR: Mapping Oral Health and Local Area Resources

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05688982
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 2,049
• Arms: 3
• Anticipated Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Diseases	Behavioral: General information provision; Behavioral: Geographic information provision; Behavioral: Navigational assistance	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2049 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: MOLAR: Mapping Oral Health and Local Area Resources
• Anticipated Study Start Date: Apr 15, 2023
• Anticipated Primary Completion Date: Oct 15, 2026
• Anticipated Study Completion Date: Apr 15, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Linkage to oral health care [Within 12 months of randomization]

   binary, completion of a dental appointment or not

Secondary Outcome Measures

1. Time to completion of dental appointment at the individual level [Within 12 months of randomization]

   continuous, days from randomization to completion of dental appointment

2. Repeat visits for oral health problems [Within 12 months of randomization]

   binary, any return visit or not

3. Rate of linkage to oral health care at the neighborhood level [Within 12 months of randomization]

   continuous rate, ranges from 0-100

4. Oral health quality of life [Within 12 months of randomization]

   Total score on OHIP-14 (continuous, ranges from 0-56).

5. Return visits [Within 12 months of initial visit]

   Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Margaret Samuels-Kalow, Associate Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05688982
• Other Study ID Numbers: UH3/UG3DE031920
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomatognathic Diseases

Study Results

No Results Posted as of Jan 18, 2023