Trial Outcomes & Findings for Meaningful Use of Technology to Improve Health Care Delivery (NCT NCT01641380)
NCT ID: NCT01641380
Last Updated: 2021-03-02
Results Overview
Participants who returned on-time for appointments
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
9 months
Results posted on
2021-03-02
Participant Flow
This research study was conducted in a large urban academic General Pediatric and Adolescent Medicine Practice in Baltimore, Maryland between October 2011 and February 2012.
Participant milestones
| Measure |
Control
Adolescents in the Control Arm received standard of care. They continue to receive the DepoProvera injections through scheduled appointment, but would not receive a call from the nurse case manager regarding DepoProvera appointments until they have missed their scheduled DepoProvera appointment.
|
Text Messaging Intervention
Adolescents in the intervention arm receive text message reminders for appointments and positive sexual health messages regarding use of DepoProvera in between scheduled appointments. They are encouraged to seek care for assistance with obtaining condoms and/or if they are having problems with the medication.
Text Messaging Intervention:
1. Online enrollment in the Compliance for Life® (CFL) system through iReminder)
2. Welcome Message 24 hrs after enrollment
3. Appointment Reminder prior to 3 month injection cycles
4. Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder
6.Call for missed appointment or no reply to appointment reminder (or other text message)
|
|---|---|---|
|
First Injection Cycle
STARTED
|
50
|
50
|
|
First Injection Cycle
COMPLETED
|
43
|
44
|
|
First Injection Cycle
NOT COMPLETED
|
7
|
6
|
|
Second Injection Cycle
STARTED
|
43
|
44
|
|
Second Injection Cycle
COMPLETED
|
39
|
38
|
|
Second Injection Cycle
NOT COMPLETED
|
4
|
6
|
|
Third Injection Cycle
STARTED
|
39
|
38
|
|
Third Injection Cycle
COMPLETED
|
36
|
33
|
|
Third Injection Cycle
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Meaningful Use of Technology to Improve Health Care Delivery
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded "no" to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder.
|
Control
n=50 Participants
Standard of care
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Evaluated differences in percentage of participants who return for on-time DepoProvera appointments for first cycle
Participants who returned on-time for appointments
Outcome measures
| Measure |
Intervention
n=50 Participants
Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded "no" to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder.
|
Control
n=50 Participants
Standard of care
|
|---|---|---|
|
Appointment Adherence (Efficacy)
|
34 participants
|
28 participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Participants in the control group did not receive text messages (intervention) and so no data was collected for them.
Overall responsiveness to delivery confirmation requests with A) Appointment messages and B) Informational Messages
Outcome measures
| Measure |
Intervention
n=50 Participants
Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded "no" to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder.
|
Control
Standard of care
|
|---|---|---|
|
Responsiveness to Appointment Messages
Responded to appointment messages
|
38 participants
|
—
|
|
Responsiveness to Appointment Messages
Responded to Informational messages
|
34 participants
|
—
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants in the control group did not receive text messages (intervention) and so no data was collected for them.
% of patients indicating satisfaction with the messaging reminder/health information service
Outcome measures
| Measure |
Intervention
n=25 Participants
Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded "no" to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder.
|
Control
Standard of care
|
|---|---|---|
|
Proportion of Patients Satisfied With Messaging Service
Satisfied with the program
|
25 participants
|
—
|
|
Proportion of Patients Satisfied With Messaging Service
Felt more connected to the clinic
|
24 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline RecruitmentPopulation: Number of eligible participants among those approached
To determine acceptability we measured the number of individuals who were eligible for the trial and the number of eligible individuals who agreed to participate in the trial.
Outcome measures
| Measure |
Intervention
n=116 Participants
Youth assigned to the DepoText intervention arm also received a welcome text message, daily text appointment reminders using the Compliance for Life (CFL) ™ short messaging system (SMS) platform starting 72 hours before the clinical visit with the option to cease messages by responding (yes or no) with their plans to attend the visit. If the patient responded "no" to appointment reminders, then an email was automatically sent to the nurse case manager who contacted the patient to reschedule the appointment. Intervention adolescents also received prescheduled health messages regarding condom use for STI prevention, healthy weight management, encouragement to call the nurse for problems, and an STI screening reminder.
|
Control
Standard of care
|
|---|---|---|
|
Acceptability
|
100 participants
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria Trent, MD, MPH, Principal Investigator
Johns Hopkins University School of Medicine
Phone: 443-287-8945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place