Reducing Teen Pregnancy in the Emergency Department

NCT03866811 | Completed Results DMC

• 2 other identifiers: AAAR6781 (Part 2)1K23HD096060-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reproductive Behavior; Sexual Behavior; Adolescent Behavior; Contraception

Keywords

emergency medicine; reproductive health; sexual health; adolescent health; emergency department; text messaging; mobile health; digital health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Feasibility: Percentage of Refusal

  Baseline

• Feasibility: Opt Outs Measured Via Mobile Platform

  3 months

• Number of Enrolled Participants Who do Not Complete Follow up

  3 months

• Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey

  3 months

• Any Sex Over the Past 3 Months

  1 year

Other Outcomes (1)

• Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care

  3 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.

Interventions

Dr. Erica BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: Female adolescent emergency department patients
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Morgan Stanley Children's Hospital Emergency Department

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Reproductive Behavior; Sexual Behavior; Adolescent Behavior; Emergencies

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

First, this study was conducted at a single center and represents a predominantly Hispanic population. Second, our intervention was available in only English. Third, participants did not respond to all follow-up questions, which may have affected our findings.

Results Point of Contact

• Title: Dr. Lauren Chernick
• Organization: Columbia University

lc2243@columbia.edu

2123056628

Study Officials

• Lauren S. Chernick, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to study enrollment arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics in Emergency Medicine

Model Details: A randomized controlled trial with two arms

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 7, 2019
• Study Start: March 3, 2019
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)