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Reducing Teen Pregnancy in the Emergency Department (ERICA)

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ClinicalTrials.gov Identifier: NCT03866811
Recruitment Status : Completed
First Posted : March 7, 2019
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lauren S. Chernick, Columbia University

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.

Condition or disease Intervention/treatment Phase
Reproductive Behavior Sexual Behavior Adolescent Behavior Contraception Behavioral: Dr. Erica Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial with two arms
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded to study enrollment arm.
Primary Purpose: Prevention
Official Title: Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy
Actual Study Start Date : March 3, 2019
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : July 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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.



Primary Outcome Measures :
  1. Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]

    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

  2. Potential Efficacy: Contraceptive at Last Intercourse Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Rates of contraceptive use at last intercourse will be reported by participants via telephone or online survey. Condom use will be included.


Secondary Outcome Measures :
  1. Feasibility: Percentage of refusal [Baseline at enrollment] [ Time Frame: Baseline ]
    Percentage of eligible participants who refused enrollment

  2. Feasibility: Opt outs measured via mobile platform [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Percentage of enrolled participants in the intervention group who texted to stop receiving messages

  3. Feasibility: Loss to follow up measured via online or telephone survey [Close of intervention at 12 weeks] [ Time Frame: 3 months ]
    Percentage of enrolled participants who do not complete follow up via either telephone or online survey

  4. Feasibility/Acceptability: Interaction with text messages measured via mobile platform provider [[Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Percentage of participants in the intervention group who replied to each interactive text message

  5. Acceptability: Satisfaction with the intervention measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Percentage of participants in the intervention group who answer that they like the program and would recommend it to friends


Other Outcome Measures:
  1. Exploratory Efficacy Outcome: Change in Preventive Reproductive Care Follow up measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Difference in percentages of those who follow up to preventive reproductive care in the intervention versus the control group based on telephone or online survey results

  2. Exploratory Efficacy Outcome: Change in Contraception Self-Efficacy measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)] [ Time Frame: 3 months ]
    Difference in contraception self-efficacy between those in the intervention and control groups based on data collected on the telephone or online follow up survey



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female adolescent emergency department patients
Accepts Healthy Volunteers:   Yes
Criteria

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866811


Locations
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United States, New York
Morgan Stanley Children's Hospital Emergency Department
Manhattan, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Lauren Chernick, MD MSc Columbia University
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Responsible Party: Lauren S. Chernick, Assistant Professor of Pediatrics in Emergency Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03866811    
Other Study ID Numbers: 1K23HD096060-01 ( U.S. NIH Grant/Contract )
1K23HD096060-01 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lauren S. Chernick, Columbia University:
emergency medicine
reproductive health
sexual health
adolescent health
emergency department
text messaging
mobile health
digital health
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes