MOLAR: Mapping Oral Health and Local Area Resources
ConditionDental Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
General information provision
BehavioralPatients will receive information with general oral health and aSDoH resources.
Geographic information provision
BehavioralPatients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
Navigational assistance
BehavioralPatients will receive phone-based navigational assistance from the study navigator.
Treatment groups
2,927 Participants
are divided into 3 treatment groupsGroup A: A--general informationOther 1 intervention
Group B: B--geographic informationOther 1 intervention
Group C: C--geographic information and navigational assistanceOther 2 interventions
Trial outcomes
Primary outcomes
1
Linkage to oral health care
binary, completion of a dental appointment or not
Time frame
Within 12 months of randomizationSecondary outcomes
1
Time to completion of dental appointment at the individual level
continuous, days from randomization to completion of dental appointment
Time frame
Within 12 months of randomization2
Repeat visits for oral health problems
binary, any return visit or not
Time frame
Within 12 months of randomization3
Rate of linkage to oral health care at the neighborhood level
continuous rate, ranges from 0-100
Time frame
Within 12 months of randomization4
Oral health quality of life
Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)
Time frame
Within 12 months of randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov