Trial Outcomes & Findings for Improving Follow-Up for Discharged Emergency Care Patients (NCT NCT03002311)
NCT ID: NCT03002311
Last Updated: 2020-11-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
327 participants
Primary outcome timeframe
Up to 120 days
Results posted on
2020-11-24
Participant Flow
The enrollment period for the study took place between January 1, 2016 and June 30, 2017.
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).
Participant milestones
| Measure |
Control
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
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.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
180
|
|
Overall Study
COMPLETED
|
128
|
150
|
|
Overall Study
NOT COMPLETED
|
19
|
30
|
Reasons for withdrawal
| Measure |
Control
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
26
|
|
Overall Study
Referral provider called to schedule app
|
3
|
3
|
|
Overall Study
Physician Decision
|
3
|
1
|
Baseline Characteristics
Improving Follow-Up for Discharged Emergency Care Patients
Baseline characteristics by cohort
| Measure |
Control
n=128 Participants
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
n=150 Participants
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
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
n=5 Participants
|
38.4 years
n=7 Participants
|
37.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=5 Participants
|
150 participants
n=7 Participants
|
278 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 120 daysPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=128 Participants
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
n=150 Participants
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.
|
|---|---|---|
|
Adherence to Follow-up Appointment
|
30 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Up to 120 daysThe secondary outcome was revisits to the ED after discharge.
Outcome measures
| Measure |
Control
n=128 Participants
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
n=150 Participants
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.
|
|---|---|---|
|
Revisits to the ED
|
50 Participants
|
60 Participants
|
Adverse Events
Control
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Epharmix/CareSignal eHealth Intervention
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=128 participants at risk
Receiving current standard of care as designated by emergency department (ED) standard operating practice.
|
Epharmix/CareSignal eHealth Intervention
n=150 participants at risk
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.
|
|---|---|---|
|
General disorders
Unplanned hospitalization
|
12.5%
16/128 • Number of events 16 • 120 days
SAEs consisted of deaths (none observed) or unplanned hospital admissions (see table).
|
10.7%
16/150 • Number of events 16 • 120 days
SAEs consisted of deaths (none observed) or unplanned hospital admissions (see table).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place