Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05688982

Conditions

Dental Diseases

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

General information provision

Geographic information provision

Navigational assistance

Study Details

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

Study ID

NCT05688982

Start date

Aug 25, 2023

Status verified date

Aug, 2026

Completion date

Feb 22, 2028

Anticipated

Primary completion date

Feb 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2927 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: A--general information

Patients in Arm A will receive paper handouts 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.

other: C--geographic information and navigational assistance

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

Interventions

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.

Primary outcome measure

  • Linkage to oral health care [ Time Frame: Within 12 months of randomization ]

Central Contacts and Locations

Central contacts

Margaret Samuels-Kalow

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-13.