Trial Outcomes & Findings for Reducing Teen Pregnancy in the Emergency Department (NCT NCT03866811)
NCT ID: NCT03866811
Last Updated: 2024-08-06
Results Overview
Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following: * intrauterine device * birth control implant * birth control patch * birth control pills or oral contraceptives * injectable birth control * a vaginal ring
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
3 months
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Intervention Arm
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
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Control Arm
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
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|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
COMPLETED
|
59
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Teen Pregnancy in the Emergency Department
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=72 Participants
Dr. Erica consists of two parts-a digital ED-based brief intervention and multimedia text messaging.
|
Control Arm
n=74 Participants
Those randomized to usual care received an introductory text message to ensure texting capabilities for follow-up. No other edu- cation was provided outside usual care in the ED.
|
Total
n=146 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Customized
14-17 years old
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Customized
18-19 years old
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 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
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown (data not collected)
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Only participants who provided self-report updates at the 3 months follow up mark were included in the analysis.
Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following: * intrauterine device * birth control implant * birth control patch * birth control pills or oral contraceptives * injectable birth control * a vaginal ring
Outcome measures
| Measure |
Intervention Arm
n=57 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
n=64 Participants
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
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|---|---|---|
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Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]
|
14 Participants
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14 Participants
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SECONDARY outcome
Timeframe: BaselinePopulation: Includes those who were eligible for enrollment who were screened for study participation.
Percentage of eligible participants who refused
Outcome measures
| Measure |
Intervention Arm
n=173 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
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Feasibility: Percentage of Refusal
|
27 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPercentage of enrolled participants in the intervention group who texted to stop receiving messages.
Outcome measures
| Measure |
Intervention Arm
n=72 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
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Feasibility: Opt Outs Measured Via Mobile Platform
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Includes the total number of participants randomized to each arm, regardless of follow up completion.
Measurement of the feasibility of Dr. Erica among adolescent female users
Outcome measures
| Measure |
Intervention Arm
n=72 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
n=74 Participants
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
|
Number of Enrolled Participants Who do Not Complete Follow up
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15 Participants
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10 Participants
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SECONDARY outcome
Timeframe: 3 monthsPopulation: Includes all participants in the intervention arm who completed the required follow up post-intervention.
Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends
Outcome measures
| Measure |
Intervention Arm
n=49 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
|
Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Includes participants in each arm who completed the follow-up post-intervention.
Self-report of any over the past 3 months.
Outcome measures
| Measure |
Intervention Arm
n=49 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
n=59 Participants
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
|
Any Sex Over the Past 3 Months
|
39 Participants
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: This population answered "yes" or "no" the question prompted by Dr. Erica: "Over the past 3 months, have you been to the Columbia Family Planning Clinic?"
Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered "yes" to the question: "Over the past 3 months, have you seen a doctor for medical care?" In this Outcome, "preventative reproductive care" is defined as any visit to a doctor for the purposes of reproductive health.
Outcome measures
| Measure |
Intervention Arm
n=52 Participants
The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).
Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
|
Control Arm
n=58 Participants
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
|
|---|---|---|
|
Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care
|
35 Participants
|
42 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place