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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03834441
Other study ID # 2019P000128
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 7, 2019
Est. completion date February 20, 2020

Study information

Verified date January 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date February 20, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oral HRSN screening
Verbal screening delivered by an RA
Written HRSN screening
Patient completes written screen on iPad.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Health Related Social Needs Reported We will record the number of health related social needs reported Immediately after completing survey
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