Improving Follow-Up for Discharged Emergency Care Patients

NCT ID: NCT03002311

Last Updated: 2020-11-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-03-09

Brief Summary

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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

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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.

Conditions

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General Medicine Emergency Medicine Mobile Health

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SMS text messaging to prompt adherence with follow-up appointment.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Epharmix/CareSignal eHealth

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epharmix, Inc.

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Will R Ross, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

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Reference Type DERIVED
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Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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201504079

Identifier Type: -

Identifier Source: org_study_id