Emergency Medicine, General Medicine, Mobile Health
Conditions
Keywords
Bioinformatics, Electronic pharmacology, Mobile health, Electronic health, Adherence, Digital health, Health information technology, mHealth, eHealth
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.
Interventions
DEVICEEpharmix/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.
Sponsors
Epharmix, Inc.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
SMS text messaging to prompt adherence with follow-up appointment.
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Revisits to the ED | Up to 120 days | The secondary outcome was revisits to the ED after discharge. |
Countries
United States
Participant flow
Recruitment details
The enrollment period for the study took place between January 1, 2016 and June 30, 2017.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Control Receiving current standard of care as designated by emergency department (ED) standard operating practice. | 128 |
| 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. | 150 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 26 |
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Referral provider called to schedule app | 3 | 3 |
Baseline characteristics
| Characteristic | Control | Total | Epharmix/CareSignal eHealth Intervention |
|---|---|---|---|
| Age, Continuous | 36.5 years | 37.5 years | 38.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 267 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 87 Participants | 187 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) White | 30 Participants | 70 Participants | 40 Participants |
| Region of Enrollment United States | 128 participants | 278 participants | 150 participants |
| Sex: Female, Male Female | 82 Participants | 180 Participants | 98 Participants |
| Sex: Female, Male Male | 46 Participants | 98 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 150 |
| other Total, other adverse events | 0 / 128 | 0 / 150 |
| serious Total, serious adverse events | 16 / 128 | 16 / 150 |
Outcome results
Primary
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.
Time frame: Up to 120 days
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Adherence to Follow-up Appointment | 30 Participants |
| Epharmix/CareSignal eHealth Intervention | Adherence to Follow-up Appointment | 74 Participants |
p-value: <0.001Gray's test
Secondary
Revisits to the ED
The secondary outcome was revisits to the ED after discharge.
Time frame: Up to 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Revisits to the ED | 50 Participants |
| Epharmix/CareSignal eHealth Intervention | Revisits to the ED | 60 Participants |
p-value: 0.8Gray's test