Optimized Health-Related Social Needs Screening and Community Linkages

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.

Study Overview

• Status: Completed
• Conditions: Emergencies
• Intervention / Treatment: Other: Oral HRSN screening; Other: Written HRSN screening

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Oral screening	Other: Oral HRSN screening; Verbal screening delivered by an RA
OTHER: Written screening	Other: Written HRSN screening; Patient completes written screen on iPad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Health Related Social Needs Reported	We will record the number of health related social needs reported	Immediately after completing survey

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Margaret Samuels-Kalow, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2019
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): February 20, 2020

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (ACTUAL): February 8, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: social needs
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2019P000128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No