What this study is
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.
What's being tested
- General information provision
Intervention · BEHAVIORAL
Patients will receive information with general oral health and aSDoH resources.
- Geographic information provision
Intervention · BEHAVIORAL
Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
- Navigational assistance
Intervention · BEHAVIORAL
Patients will receive phone-based navigational assistance from the study navigator.
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- Dental Diseases
- Enrolling
- 2,927 people
- Starts
- 2023-08-25
- Est. completion
- 2028-02-22
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Year and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Margaret Samuels-Kalow, MD MSHP · Contact
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2022P003224
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.