NCT04058301

Brief Summary

The goal of this study is to pilot test a novel tool for health related social needs screening and linkage to community resources in the ED by randomizing participants to standard handout v. handout + text message with resource information.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 17, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

May 17, 2019

Last Update Submit

January 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satisfaction: Likert scale

    Participants will be asked about their satisfaction with the program measured on a Likart scale. Options will include "Extremely or Quite a bit; Somewhat; A little bit or Not at all"

    3-5 days

Secondary Outcomes (2)

  • Resource use

    3-5 days

  • Health status

    3-5 days

Other Outcomes (1)

  • ED utilization

    30 days

Study Arms (2)

Handout

NO INTERVENTION

Participants receive a generic handout about resources in Boston

Text message

EXPERIMENTAL

Participants receive a generic handout about resources in Boston and a text message with a geographically proximate resource

Other: Text message information

Interventions

Geographically proximate resources delivered by text message

Text message

Eligibility Criteria

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

You may qualify if:

  • ZIP codes included in our database of community resources ("catchment area")
  • \>=18 years old
  • plan for discharge home
  • speak either English or Spanish
  • live within the catchment area for the study
  • have a cellphone with text messaging capabilities
  • ability to respond to text messages from the study team.

You may not qualify if:

  • Patients who are intoxicated
  • on a Section 12
  • lack capacity to consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

August 15, 2019

Study Start

December 9, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations