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Social Needs Screenings in ED

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ClinicalTrials.gov Identifier: NCT04630041
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Andrea Wallace, University of Utah

Tracking Information
First Submitted Date  ICMJE November 11, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
Health Utilization Outcome questionnaire [ Time Frame: 60 days ]
The variable will be created by combining primary care utilization (yes/no), ED revisit (yes/no), and hospitalization (yes/no) within 60 days of original ED visit. Scores range from 0 to 3. Higher scores indicate worse health utilization outcomes.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Social Needs Screenings in ED
Official Title  ICMJE Implementation Barriers to Social Needs Screenings in Routine Emergency Care
Brief Summary

This study will determine whether existing Health Information Technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine Emergency Department care; 2) understand whether linking social needs assessment, community based referral, and health outcomes data may facilitate an understanding of population health; and 3) address the needs and wishes of patients and clinicians.

Hypothesis: Results of this study will provide much needed information to already overburdened hospital systems regarding whether systematically incorporating social needs information and referrals into emergency discharge processes allows for a better understanding of factors placing patients at risk for poor outcomes post-discharge, and whether doing so has potential for enhancing discharge support for a larger patient population seen in emergency departments.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Social Determinants of Health
Intervention  ICMJE Behavioral: 211 Referral
Patients with one or more reported social need will be referred to 211 for community based services. 211 will reach out and contact patients for follow-up.
Study Arms  ICMJE Experimental: Social Needs Assessment
Patients in the Emergency Department will complete a social needs assessment screener that may refer them to 211 services
Intervention: Behavioral: 211 Referral
Publications * Wallace AS, Luther BL, Sisler SM, Wong B, Guo JW. Integrating social determinants of health screening and referral during routine emergency department care: evaluation of reach and implementation challenges. Implement Sci Commun. 2021 Oct 7;2(1):114. doi: 10.1186/s43058-021-00212-y.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2020)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • seen in the UHealth University hospital ED
  • ability to use touchpad technology
  • ability to communicate via telephone for 211 follow-up

Exclusion Criteria:

  • Non-English and non-Spanish speaking (English nor Spanish need not be the 1st language)
  • unable to communicate verbally
  • admitted to an inpatient unit or to a skilled nursing facility (vs discharged to a community-based setting where participants are responsible for their own self-care)
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 NCT04630041
Other Study ID Numbers  ICMJE 00125877
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
Current Responsible Party Andrea Wallace, University of Utah
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Andrea Wallace
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date November 2020

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