Reducing Teen Pregnancy in the Emergency Department (ERICA)

Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy

This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.

Study Overview

• Status: Completed
• Conditions: Contraception; Sexual Behavior; Adolescent Behavior; Reproductive Behavior
• Intervention / Treatment: Behavioral: Dr. Erica

Detailed Description

Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population.

In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone.

At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Morgan Stanley Children's Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• female emergency department patient
• age 14-19 years
• sexually active with males in the past 3 months

Exclusion Criteria:

• currently using any effective form of contraception
• do not own a mobile phone with texting
• are pregnant
• are too ill for participation per the attending physician
• are cognitively impaired
• do not live locally
• do not speak English
• want to "become pregnant in the next year"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
No Intervention: Control arm; Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Percentage of Refusal	Percentage of eligible participants who refused	Baseline
Feasibility: Opt Outs Measured Via Mobile Platform	Percentage of enrolled participants in the intervention group who texted to stop receiving messages.	3 months
Number of Enrolled Participants Who do Not Complete Follow up	Measurement of the feasibility of Dr. Erica among adolescent female users	3 months
Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey	Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends	3 months
Any Sex Over the Past 3 Months	Self-report of any over the past 3 months.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care	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.	3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Lauren S. Chernick, MD, MSc, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: mobile health; reproductive health; emergency department; digital health; text messaging; sexual health; emergency medicine; adolescent health
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: AAAR6781 (Part 2); 1K23HD096060-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No