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Text-Enabled Ascertainment and Community Linkage for Health (TEACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058301
Recruitment Status : Suspended (COVID-19)
First Posted : August 15, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Margaret Samuels-Kalow, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE August 15, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE December 9, 2019
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
Satisfaction: Likert scale [ Time Frame: 3-5 days ]
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"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Resource use [ Time Frame: 3-5 days ]
    Participants will be asked about actual and planned resource use
  • Health status [ Time Frame: 3-5 days ]
    Participants will be asked about health status. In general, how would you rate your health? Excellent, Very good, Good or Fair,Poor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 14, 2019)
ED utilization [ Time Frame: 30 days ]
Chart review of ED visits and potentially preventable utilization
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Text-Enabled Ascertainment and Community Linkage for Health
Official Title  ICMJE Text-Enabled Ascertainment and Community Linkage for Health
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Emergency Medicine
Intervention  ICMJE Other: Text message information
Geographically proximate resources delivered by text message
Study Arms  ICMJE
  • No Intervention: Handout
    Participants receive a generic handout about resources in Boston
  • Experimental: Text message
    Participants receive a generic handout about resources in Boston and a text message with a geographically proximate resource
    Intervention: Other: Text message information
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 14, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 51 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.

Exclusion Criteria:

  • Patients who are intoxicated
  • on a Section 12
  • lack capacity to consent will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04058301
Other Study ID Numbers  ICMJE 2019P001579
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Margaret Samuels-Kalow, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP