Improving Follow-Up for Discharged Emergency Care Patients

NCT03002311 | Completed Results

• 1 other identifier: 201504079
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

This study's purpose is to test the effects of an electronic health intervention platform developed by Epharmix (also known as CareSignal), which features two-way SMS text messages and phone calls intended to improve clinical outcomes compared to the standard of care. This was a randomized open, blinded end-point (PROBE) trial of adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard of care written instructions to contact listed referral providers. The primary outcome was time to the follow-up appointment.

Conditions

General Medicine; Emergency Medicine; Mobile Health

Keywords

Bioinformatics; Electronic pharmacology; Mobile health; Electronic health; Adherence; Digital health; Health information technology; mHealth; eHealth

Outcome Measures

Primary Outcomes (1)

• Adherence to Follow-up Appointment

  The primary outcome was the effect of the intervention on time to follow-up appointment using an intention-to-treat analysis and plotting the cumulative incidence functions (CIFs). Follow-up adherence was defined as a recorded visit in the EMR to the referral primary or specialty care provider within 120 days after ED discharge to address a similar diagnosis (or complaint) at the index ED visit.

  Up to 120 days

Secondary Outcomes (1)

• Revisits to the ED

  Up to 120 days

Study Arms (2)

Control

NO INTERVENTION

Receiving current standard of care as designated by emergency department (ED) standard operating practice.

Epharmix/CareSignal eHealth Intervention

EXPERIMENTAL

After randomization, participants receive text reminders to have a follow-up visit. The participant can respond to these messages via numerical or binary answers (Y/N).

Device: Epharmix/CareSignal eHealth

Interventions

Epharmix/CareSignal eHealth DEVICE

The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm if they attended.

Epharmix/CareSignal eHealth Intervention

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older,
• accessible short message service (SMS) capable mobile phone or residential landline,
• able to read English or have English-speaking family member to assist with phone communications,
• discharged directly from the Barnes Jewish hospital (St. Louis, MO) emergency department (ED), and
• given a clinical referral to make an outpatient follow-up appointment at time of discharge to a specific clinic or provider

You may not qualify if:

• unable or refused to provide consent,
• could not be contacted by a phone call or SMS,
• non-English speaking,
• were admitted to the hospital, and
• already had a follow-up appointment scheduled before being discharged from the ED

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Epharmix, Inc.: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

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  PMID: 8235736 BACKGROUND

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  PMID: 23390210 BACKGROUND

• Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.

  PMID: 23329469 BACKGROUND

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  PMID: 23596071 BACKGROUND

• Lieberman DZ, Kelly TF, Douglas L, Goodwin FK. A randomized comparison of online and paper mood charts for people with bipolar disorder. J Affect Disord. 2010 Jul;124(1-2):85-9. doi: 10.1016/j.jad.2009.10.019. Epub 2009 Nov 6.

  PMID: 19896202 BACKGROUND

• Sawan M, Salam MT, Le Lan J, Kassab A, Gelinas S, Vannasing P, Lesage F, Lassonde M, Nguyen DK. Wireless recording systems: from noninvasive EEG-NIRS to invasive EEG devices. IEEE Trans Biomed Circuits Syst. 2013 Apr;7(2):186-95. doi: 10.1109/TBCAS.2013.2255595.

  PMID: 23853301 BACKGROUND

• Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

  PMID: 21080835 BACKGROUND

• Bauer KL, Sogade OO, Gage BF, Ruoff B, Lewis L. Improving Follow-up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-schedule: A Randomized Controlled Trial. Acad Emerg Med. 2021 Feb;28(2):197-205. doi: 10.1111/acem.14080. Epub 2020 Aug 5.

  PMID: 32654257 RESULT

• Chen RY, Feltes JR, Tzeng WS, Lu ZY, Pan M, Zhao N, Talkin R, Javaherian K, Glowinski A, Ross W. Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism. JMIR Res Protoc. 2017 Jun 16;6(6):e114. doi: 10.2196/resprot.7245.

  PMID: 28623183 DERIVED

Results Point of Contact

• Title: Brian F. Gage, MD
• Organization: WASHINGTON UNIVERSITY MEDICAL SCHOOL

bgage@wustl.edu

3144548697

Study Officials

• Will R Ross, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SMS text messaging to prompt adherence with follow-up appointment.

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2016
• Primary Completion: September 18, 2017
• Study Completion: March 9, 2018
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)