Optimized Health-Related Social Needs Screening and Community Linkages
Primary Purpose
Emergencies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral HRSN screening
Written HRSN screening
Sponsored by

About this trial
This is an interventional health services research trial for Emergencies focused on measuring social needs
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
- triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
- English- or Spanish-speaking, and
- capable of informed consent.
Exclusion Criteria:
- patients unwilling to have the interview audio-recorded,
- medically unstable patients, and
- Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Oral screening
Written screening
Arm Description
Outcomes
Primary Outcome Measures
Self-reported Satisfaction With the Screening Process
Satisfaction with screening as measured by:
Please tell us how satisfied you were with the questionnaire you just took:
Extremely Quite a bit Somewhat A little bit Not at all
Secondary Outcome Measures
Number of Health Related Social Needs Reported
We will record the number of health related social needs reported
Full Information
NCT ID
NCT03834441
First Posted
February 5, 2019
Last Updated
January 23, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03834441
Brief Title
Optimized Health-Related Social Needs Screening and Community Linkages
Official Title
Optimized Health-Related Social Needs Screening and Community Linkages
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED.
Detailed Description
Bilingual research assistants (RA) will screen patients for eligibility based on the predetermined criteria and approach eligible patients with a brief description of the study and opportunity for participation. Interested participants will complete a verbal consent process to reduce the barriers to participation, a brief demographic questionnaire, and an assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN screener randomized to an oral v. iPad screening strategy.
After completion of the screening tool, participants will complete a secondary questionnaire asking about satisfaction with the process, the presence of additional HRSN not recorded by the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all participants will be provided with standardized, bilingual list of community resources to address each of the screening domains.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
social needs
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral screening
Arm Type
Other
Arm Title
Written screening
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Oral HRSN screening
Intervention Description
Verbal screening delivered by an RA
Intervention Type
Other
Intervention Name(s)
Written HRSN screening
Intervention Description
Patient completes written screen on iPad.
Primary Outcome Measure Information:
Title
Self-reported Satisfaction With the Screening Process
Description
Satisfaction with screening as measured by:
Please tell us how satisfied you were with the questionnaire you just took:
Extremely Quite a bit Somewhat A little bit Not at all
Time Frame
Immediately after completing survey
Secondary Outcome Measure Information:
Title
Number of Health Related Social Needs Reported
Description
We will record the number of health related social needs reported
Time Frame
Immediately after completing survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
English- or Spanish-speaking, and
capable of informed consent.
Exclusion Criteria:
patients unwilling to have the interview audio-recorded,
medically unstable patients, and
Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Samuels-Kalow
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Learn more about this trial
Optimized Health-Related Social Needs Screening and Community Linkages
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