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CompletedNCT03834441Updated Feb 9, 2023Results posted

Optimized Health-Related Social Needs Screening and Community Linkages

An interventional study of Oral HRSN screening and Written HRSN screening in Emergencies, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Emergencies

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Keywords

  • social needs
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 236 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
  2. triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
  3. English- or Spanish-speaking, and
  4. capable of informed consent.

Exclusion criteria

Exclusion Criteria:

  1. patients unwilling to have the interview audio-recorded,
  2. medically unstable patients, and
  3. Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (actual)

Study arms

  • Other
    Oral screening

    Other: Oral HRSN screening

  • Other
    Written screening

    Other: Written HRSN screening

Interventions

  • OtherOral HRSN screening

    Verbal screening delivered by an RA

  • OtherWritten HRSN screening

    Patient completes written screen on iPad.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Immediately after completing survey

Secondary outcomes

  1. Number of Health Related Social Needs Reported

    We will record the number of health related social needs reported

    Time frame: Immediately after completing survey

07

Results

Posted Feb 9, 2023

Participant flow

Allocation
Participant flow — Allocation
MilestoneOral ScreeningWritten Screening
Started115121
Completed112116
Not completed35
Analysis
Participant flow — Analysis
MilestoneOral ScreeningWritten Screening
Started112116
Completed105109
Not completed77

Outcome measures

PrimarySelf-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

Time frame:
Immediately after completing survey
Reported as:
Count of participants · Participants
Self-reported Satisfaction With the Screening Process
ParticipantsOral ScreeningWritten Screening
Extremely/quite a bit9497
Somewhat/a little/ not at all1215
Missing99
SecondaryNumber of Health Related Social Needs Reported

We will record the number of health related social needs reported

Time frame:
Immediately after completing survey
Reported as:
Count of participants · Participants
Number of Health Related Social Needs Reported
ParticipantsOral ScreeningWritten Screening
None7093
At least one4528

Adverse events

Collected over Through study completion (no more than 1 day).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Screening0/115 (0%)0/115 (0%)0/115 (0%)
Written Screening0/121 (0%)0/121 (0%)0/121 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral ScreeningWritten ScreeningTotal
Mean41 ± 1539 ± 1540 ± 15
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Oral ScreeningWritten ScreeningTotal
Male425597
Female7264136
Other011
Missing112
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Oral ScreeningWritten ScreeningTotal
Hispanic252853
White NH6572137
Black NH9514
Other NH141630
Missing/declined202
Health literacy
Health literacy(participants)Oral ScreeningWritten ScreeningTotal
Adequate6972141
Limited424688
Missing437
08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

References and documents

Study documents

  • Study protocol · Feb 14, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to share IPD.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03834441
Lead sponsor
Massachusetts General Hospital
Responsible party
Margaret Samuels-Kalow (Assistant Professor, Massachusetts General Hospital) — Principal investigator
First posted
Feb 8, 2019
Start date
May 7, 2019
Primary completion
Sep 1, 2019
Completion
Feb 20, 2020
Results posted
Feb 9, 2023
Last update
Feb 9, 2023

Study contacts

Margaret Samuels-Kalow
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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