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Improving Follow-Up for Discharged Emergency Care Patients

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ClinicalTrials.gov Identifier: NCT03002311
Recruitment Status : Completed
First Posted : December 23, 2016
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
Epharmix, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
General Medicine Emergency Medicine Mobile Health Device: Epharmix/CareSignal eHealth Not Applicable

Detailed Description:

Telemedicine is a modern field of clinical medicine that strives to incorporate telecommunication and information technology for diagnosing and managing health care at a distance. Interventions range from telephone reminders to remote physician consultation by streamed by webcam. Simple technology such as telephone and SMS texting are becoming common forms of communication and may improve patient adherence and engagement. Automated telephone appointment reminders have improved adherence with follow-up appointments in some settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.

An electronic intervention platform has been developed by Epharmix (now HealthSignal), uses SMS text messaging for adherence tracking and data collection applications, to supplement clinical care. Specific messages include: proactively asking patients or a designated patient advocate if the patient has experienced a medical event; requesting specific care-related information; and providing health care education. Patients receiving the messages are also provided with key contact information for their designated health care provider to promote patient engagement, as well as prompt and appropriate medical follow-up care. The service will maintain both a dedicated SMS and phone line for recording events or adverse reactions. Events designated as critical prompt a phone call from nursing staff. Overall, this study aims to determine whether an electronic intervention system that sends SMS text messages will improve adherence to follow-up appointments after an ED visit.

Patients age 18 years or older at Barnes Jewish Hospital are included in this study. We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 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 using the Epharmix (now HealthSignal) platform that 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 appointment. The secondary outcome was time to return visit to the ED.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SMS text messaging to prompt adherence with follow-up appointment.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : September 18, 2017
Actual Study Completion Date : March 9, 2018

Arm Intervention/treatment
No Intervention: Control
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
Experimental: Epharmix/CareSignal eHealth Intervention
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
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.




Primary Outcome Measures :
  1. Adherence to Follow-up Appointment [ Time Frame: Up to 120 days ]
    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.


Secondary Outcome Measures :
  1. Revisits to the ED [ Time Frame: Up to 120 days ]
    The secondary outcome was revisits to the ED after discharge.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002311


Locations
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United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Epharmix, Inc.
Investigators
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Principal Investigator: Will R Ross, MD, MPH Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03002311    
Other Study ID Numbers: 201504079
First Posted: December 23, 2016    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Washington University School of Medicine:
Bioinformatics
Electronic pharmacology
Mobile health
Electronic health
Adherence
Digital health
Health information technology
mHealth
eHealth
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes