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Improving Follow-Up for Discharged Emergency Care Patients

Primary Purpose

General Medicine, Emergency Medicine, Mobile Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epharmix/CareSignal eHealth
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Medicine focused on measuring Bioinformatics, Electronic pharmacology, Mobile health, Electronic health, Adherence, Digital health, Health information technology, mHealth, eHealth

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Epharmix/CareSignal eHealth Intervention

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Revisits to the ED
The secondary outcome was revisits to the ED after discharge.

Full Information

First Posted
November 23, 2016
Last Updated
November 2, 2020
Sponsor
Washington University School of Medicine
Collaborators
Epharmix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03002311
Brief Title
Improving Follow-Up for Discharged Emergency Care Patients
Official Title
Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 18, 2017 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Epharmix, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Medicine, Emergency Medicine, Mobile Health
Keywords
Bioinformatics, Electronic pharmacology, Mobile health, Electronic health, Adherence, Digital health, Health information technology, mHealth, eHealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
SMS text messaging to prompt adherence with follow-up appointment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
Arm Title
Epharmix/CareSignal eHealth Intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Epharmix/CareSignal eHealth
Intervention Description
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 Measure Information:
Title
Adherence to Follow-up Appointment
Description
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.
Time Frame
Up to 120 days
Secondary Outcome Measure Information:
Title
Revisits to the ED
Description
The secondary outcome was revisits to the ED after discharge.
Time Frame
Up to 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will R Ross, MD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Improving Follow-Up for Discharged Emergency Care Patients

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