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Improving Follow-Up for Discharged Emergency Care Patients

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03002311
Collaborator
Epharmix, Inc. (Industry)
327
Enrollment
1
Location
2
Arms
26.2
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Epharmix/CareSignal eHealth
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
327 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
SMS text messaging to prompt adherence with follow-up appointment.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 :
Jan 1, 2016
Actual Primary Completion Date :
Sep 18, 2017
Actual Study Completion Date :
Mar 9, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adherence to Follow-up Appointment [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 [Up to 120 days]

    The secondary outcome was revisits to the ED after discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barnes Jewish Hospital Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • Epharmix, Inc.

Investigators

  • Principal Investigator: Will R Ross, MD, MPH, Washington University School of Medicine

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03002311
Other Study ID Numbers:
  • 201504079
First Posted:
Dec 23, 2016
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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:
Emergencies

Study Results

Participant Flow

Recruitment Details The enrollment period for the study took place between January 1, 2016 and June 30, 2017.
Pre-assignment Detail Of 933 patients screened, 35% were enrolled. Of those screened, 4.5% of patients were excluded because they did not have a phone and 2.0% were excluded because they were non-English speaking. The largest groups excluded were those who did not want to participate (n=300) and those who were given a specific referral (n=107).
Arm/Group Title Control Epharmix/CareSignal eHealth Intervention
Arm/Group Description Receiving current standard of care as designated by emergency department (ED) standard operating practice. 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 attendance.
Period Title: Overall Study
STARTED 147 180
COMPLETED 128 150
NOT COMPLETED 19 30

Baseline Characteristics

Arm/Group Title Control Epharmix/CareSignal eHealth Intervention Total
Arm/Group Description Receiving current standard of care as designated by emergency department (ED) standard operating practice. 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 attendance. Total of all reporting groups
Overall Participants 128 150 278
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
36.5
38.4
37.5
Sex: Female, Male (Count of Participants)
Female
82
64.1%
98
65.3%
180
64.7%
Male
46
35.9%
52
34.7%
98
35.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
3
2.3%
5
3.3%
8
2.9%
Not Hispanic or Latino
124
96.9%
143
95.3%
267
96%
Unknown or Not Reported
1
0.8%
2
1.3%
3
1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
87
68%
100
66.7%
187
67.3%
White
30
23.4%
40
26.7%
70
25.2%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
11
8.6%
10
6.7%
21
7.6%
Region of Enrollment (participants) [Number]
United States
128
100%
150
100%
278
100%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Modified intent-to treat-analysis: Participants were excluded if they were admitted to the hospital after consenting, if their doctor called to schedule the follow-up appointment, or if they were lost to follow up.
Arm/Group Title Control Epharmix/CareSignal eHealth Intervention
Arm/Group Description Receiving current standard of care as designated by emergency department (ED) standard operating practice. 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 attendance.
Measure Participants 128 150
Count of Participants [Participants]
30
23.4%
74
49.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Epharmix/CareSignal eHealth Intervention
Comments
Type of Statistical Test Superiority
Comments We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Gray's test
Comments We compared the cumulative incidence function.
2. Secondary Outcome
Title Revisits to the ED
Description The secondary outcome was revisits to the ED after discharge.
Time Frame Up to 120 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Epharmix/CareSignal eHealth Intervention
Arm/Group Description Receiving current standard of care as designated by emergency department (ED) standard operating practice. 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 attendance.
Measure Participants 128 150
Count of Participants [Participants]
50
39.1%
60
40%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Epharmix/CareSignal eHealth Intervention
Comments
Type of Statistical Test Superiority
Comments This was a secondary analysis so no power analysis was done.
Statistical Test of Hypothesis p-Value 0.8
Comments We used a two-sided alpha of 0.05 to determine significance.
Method Gray's test
Comments We compared the cumulative incidence functions.

Adverse Events

Time Frame 120 days
Adverse Event Reporting Description SAEs consisted of deaths (none observed) or unplanned hospital admissions (see table).
Arm/Group Title Control Epharmix/CareSignal eHealth Intervention
Arm/Group Description Receiving current standard of care as designated by emergency department (ED) standard operating practice. 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 attendance.
All Cause Mortality
Control Epharmix/CareSignal eHealth Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/128 (0%) 0/150 (0%)
Serious Adverse Events
Control Epharmix/CareSignal eHealth Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 16/128 (12.5%) 16/150 (10.7%)
General disorders
Unplanned hospitalization 16/128 (12.5%) 16 16/150 (10.7%) 16
Other (Not Including Serious) Adverse Events
Control Epharmix/CareSignal eHealth Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/128 (0%) 0/150 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Brian F. Gage, MD
Organization WASHINGTON UNIVERSITY MEDICAL SCHOOL
Phone 3144548697
Email bgage@wustl.edu
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03002311
Other Study ID Numbers:
  • 201504079
First Posted:
Dec 23, 2016
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020