NCT03834441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 9, 2023

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

February 5, 2019

Results QC Date

January 27, 2022

Last Update Submit

January 23, 2023

Conditions

Keywords

social needs

Outcome Measures

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

    Immediately after completing survey

Secondary Outcomes (1)

  • Number of Health Related Social Needs Reported

    Immediately after completing survey

Study Arms (2)

Oral screening

OTHER
Other: Oral HRSN screening

Written screening

OTHER
Other: Written HRSN screening

Interventions

Verbal screening delivered by an RA

Oral screening

Patient completes written screen on iPad.

Written screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Margaret Samuels-Kalow
Organization
MGH

Study Officials

  • Margaret Samuels-Kalow

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 8, 2019

Study Start

May 7, 2019

Primary Completion

September 1, 2019

Study Completion

February 20, 2020

Last Updated

February 9, 2023

Results First Posted

February 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD.

Locations