Contraception Initiation Feasibility in the Pediatric ED

March 26, 2024 updated by: Washington University School of Medicine

Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department

Many female adolescents using the pediatric emergency department (ED) are at higher risk for unintended pregnancy. This is a significant public health issue and hormonal contraception is the mainstay of prevention. Many barriers to hormonal contraception exist and other studies have demonstrated that referral from the ED for hormonal contraception leads to poor follow up.

This study will be a pilot study to assess the feasibility of initiating hormonal contraception in the pediatric ED.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will assess the feasibility of initiating hormonal contraception in the pediatric ED. Currently, all 15-21-year-old patients receiving care in our ED are asked to complete an adolescent heath questionnaire to identify risk-factors for sexually transmitted infections (STIs). Sexually active female patients who indicate on this questionnaire they are not currently using hormonal contraception will be eligible for participation in this study.

Potential participants will be screened using the EMR and eligible patients will be approached. Consent will be obtained from adults directly and from a parent or guardian for minors that have one present. For minors that present without a parent or guardian, assent only with be obtained from the minor. Participants will be randomized into two groups, an intervention group and a control group. Participants in both groups will be given tablet computer and, through a software application on the tablet, answer questions electronically about their background, medical history, and contraceptive preferences. They will then be shown a video that provides an overview of hormonal contraceptive options. Depending on the participants medical history and contraceptive preferences, they may be offered more in-depth educational videos about specific types of hormonal contraception for which they are eligible (e.g. pill, transdermal patch, intravaginal ring, injection, and implant).

Once they have completed watching the videos, participants in the intervention group will have the option of initiating one of the offered forms of birth control during the ED visit. They will only be offered medications considered low risk and for which they do not have any medical contraindications. Urine pregnancy testing will be done before any method is given. They will be able to start any contraceptive method from among those offered after their screening. Participants in the control group will be offered outpatient referral to initiate contraception, the current standard of care in our ED. All patients in both arms of the study will be given referral/follow up options for further contraceptive care.

All participants in this study will then be followed up at 1, 3, 6, and 12 months to determine continuation of contraception practices, follow up practices, satisfaction, and pregnancy rates.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington Univeristy at St Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female patients, 15-21 years old that present to the SLCH pediatric ED
  • Report history of vaginal sex on the ED routine screening questionnaire
  • Not currently using hormonal contraception

Exclusion Criteria:

  • Pregnant
  • Currently using hormonal contraception
  • Foster care
  • Non-English speaking
  • Chief complaint of psychiatric concern, physical abuse or sexual abuse
  • Triage acuity level 1 or 2 as they are likely to be too ill to participate
  • Those with history of stroke, venous thromboembolism, actively being treated for cancer, or who have an organ transplant
  • Too ill to participate as determined by the pediatric ED health care provider (attending physician or advanced practice nurse)
  • Already participated in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Using an electronic application, participants answer survey questions about their sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception. Then, based on survey answers, they will be able to watch more in-depth educational videos on methods that they qualify for. Participants will only be offered methods that are considered low risk and without any contraindication based upon responses to survey screening. This may include, contraceptive implant, medroxyprogesterone acetate injection, microgestin pills, xulane patch, or intravaginal ring. Participants will then be given the opportunity to initiate contraception in the ED. All participants will be referred for follow up outpatient health services. Subjects who have medical contraindications to certain contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s) while in the ED.
Diagnostic test: Intervention Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. Contraceptive choices being offered include the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. The participant can then decide if they would like to start a medication they qualify for in the ED.
Other: Control Group
Using an electronic application, participants answer survey questions about their background, sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception with brief pros and cons of each method. Then, based on participants medical history and contraceptive preferences they will be able to watch more in-depth counseling and educational videos on contraceptive methods that they qualify for. After these videos they will be given information on where they will be able to follow up to receive these contraceptive methods if they wish to start a method. Subjects who have medical contraindications to certain hormonal contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s), should this come up in future discussions with their providers.
Other: Control Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. This includes the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. Participants will then be given follow up information on outpatient locations where they can receive these contraceptive methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiation of contraception in the ED using the electronic application
Time Frame: 12 months
The proportion of enrolled patients that initiate contraception when offered same-day (intervention arm) compared to those that initiate contraception at follow up (the control arm) at 3 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery process related outcomes #1
Time Frame: At initial encounter.
Total length of time of the intervention beginning after consent and ending with provision of contraception, contraceptive script, or declining initiation of contraception.
At initial encounter.
Delivery process related outcomes #2
Time Frame: At initial encounter.
Subject length of stay defined by arrival time to disposition (admit or discharge) from ED.
At initial encounter.
Delivery process related outcomes #3
Time Frame: At initial encounter and at follow up at 3, 6, and 12 months.
Patient experience and satisfaction survey both directly after program and at follow up at 3, 6, and 12 months. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions.
At initial encounter and at follow up at 3, 6, and 12 months.
Delivery process related outcomes #4
Time Frame: At initial encounter.
Providers (doctors and nurses) experience and satisfaction survey for initial visit in ED. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions.
At initial encounter.
Contraceptive continuation
Time Frame: At 3,6, and 12 months.
Percentage of participants that are using hormonal contraception in the intervention group as compared to the control group at 1, 3, 6 and 12 months.
At 3,6, and 12 months.
Pregnancy rates
Time Frame: 12 months.
The number of participants that become pregnant within 12 months in the intervention group verses the control group.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

January 26, 2021

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 201805104

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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