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Contraception Initiation Feasibility in the Pediatric ED

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ClinicalTrials.gov Identifier: NCT03559634
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Contraception Contraception Behavior Diagnostic Test: Intervention Group Other: Control Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Feasibility trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Pregnancy rates [ Time Frame: 12 months. ]
    The number of participants that become pregnant within 12 months in the intervention group verses the control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be a biological female that identifies as a female.
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03559634


Contacts
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Contact: Kayleigh A Fischer, MD 314-454-2341 k.fischer@wust.edu
Contact: Fahd Ahmad, MD 314-454-2341 fahd.ahmad@wustl.edu

Locations
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United States, Missouri
Washington Univeristy at St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kayleigh Fischer, MD    314-454-2341    k.fischer@wustl.edu   
Contact: Fahd Ahmad, MD    314-454-2341    fahd.ahmad@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Merck Sharp & Dohme Corp.

Publications:
Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.
American College of Obstetricians and Gynecologists. Guidelines for adolescent health care. 2011; http://www.acog.org/About-ACOG/ACOG-Departments/Adolescent-Health-Care. Accessed Dec 2016.
American Congress of Obstetricians and Gynecologists. Statement on Teen Pregnancy and Contraception. 2015; http://www.acog.org/About-ACOG/News-Room/Statements/2015/ACOG-Statement-on-Teen-Pregnancy-and-Contraception. Accessed Dec 2016.
Healthy People 2020. Family Planning, Adolescent Health. 2014; https://www.healthypeople.gov/2020, 2017.

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03559634     History of Changes
Other Study ID Numbers: 201805104
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
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
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs