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MOLAR: Mapping Oral Health and Local Area Resources

Primary Purpose

Dental Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General information provision
Geographic information provision
Navigational assistance
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dental Diseases

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

A--general information

B--geographic information

C--geographic information and navigational assistance

Arm Description

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.

Outcomes

Primary Outcome Measures

Linkage to oral health care
binary, completion of a dental appointment or not

Secondary Outcome Measures

Time to completion of dental appointment at the individual level
continuous, days from randomization to completion of dental appointment
Repeat visits for oral health problems
binary, any return visit or not
Rate of linkage to oral health care at the neighborhood level
continuous rate, ranges from 0-100
Oral health quality of life
Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)
Return visits
Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).

Full Information

First Posted
January 9, 2023
Last Updated
October 2, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05688982
Brief Title
MOLAR: Mapping Oral Health and Local Area Resources
Official Title
MOLAR: Mapping Oral Health and Local Area Resources
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
October 15, 2026 (Anticipated)
Study Completion Date
April 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2049 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A--general information
Arm Type
Other
Arm Description
Patients in Arm A will receive paper handouts with general oral health and aSDoH resources
Arm Title
B--geographic information
Arm Type
Other
Arm Description
Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.
Arm Title
C--geographic information and navigational assistance
Arm Type
Other
Arm Description
Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.
Intervention Type
Behavioral
Intervention Name(s)
General information provision
Intervention Description
Patients will receive information with general oral health and aSDoH resources.
Intervention Type
Behavioral
Intervention Name(s)
Geographic information provision
Intervention Description
Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
Intervention Type
Behavioral
Intervention Name(s)
Navigational assistance
Intervention Description
Patients will receive phone-based navigational assistance from the study navigator.
Primary Outcome Measure Information:
Title
Linkage to oral health care
Description
binary, completion of a dental appointment or not
Time Frame
Within 12 months of randomization
Secondary Outcome Measure Information:
Title
Time to completion of dental appointment at the individual level
Description
continuous, days from randomization to completion of dental appointment
Time Frame
Within 12 months of randomization
Title
Repeat visits for oral health problems
Description
binary, any return visit or not
Time Frame
Within 12 months of randomization
Title
Rate of linkage to oral health care at the neighborhood level
Description
continuous rate, ranges from 0-100
Time Frame
Within 12 months of randomization
Title
Oral health quality of life
Description
Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)
Time Frame
Within 12 months of randomization
Title
Return visits
Description
Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).
Time Frame
Within 12 months of initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Samuels-Kalow
Phone
617-726-8340
Email
msamuels-kalow@partners.org
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Samuels-Kalow, MD MSHP

12. IPD Sharing Statement

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MOLAR: Mapping Oral Health and Local Area Resources

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