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ContraceptionNCT03559634

Contraception Initiation Feasibility in the Pediatric ED

A study testing Intervention Group in people with Contraception and Contraception Behavior, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 21 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception, Contraception Behavior
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
20 May 2019to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 21 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington Univeristy at St Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Intervention Group, Control Group
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupDiagnostic test

    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 GroupOther

    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.

Study groups in NCT03559634
Study groupRoleWhat they receive
Intervention groupExperimentalUsing 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.
Receives: Diagnostic Test: Intervention Group
Control GroupOtherUsing 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.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Initiation of contraception in the ED using the electronic application

    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.

    Measured: 12 months

Secondary outcomes (6)

  1. Delivery process related outcomes #1

    Total length of time of the intervention beginning after consent and ending with provision of contraception, contraceptive script, or declining initiation of contraception.

    Measured: At initial encounter.

  2. Delivery process related outcomes #2

    Subject length of stay defined by arrival time to disposition (admit or discharge) from ED.

    Measured: At initial encounter.

  3. Delivery process related outcomes #3

    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.

    Measured: At initial encounter and at follow up at 3, 6, and 12 months.

  4. Delivery process related outcomes #4

    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.

    Measured: At initial encounter.

  5. Contraceptive continuation

    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.

    Measured: At 3,6, and 12 months.

  6. Pregnancy rates

    The number of participants that become pregnant within 12 months in the intervention group verses the control group.

    Measured: 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start20 May 2019
  3. Primary completion26 Jan 2021
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility trial
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559634
Sponsor's protocol ID
201805104
Status last verified
Mar 2024
First submitted
22 May 2018
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

  • Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1244-56. doi: 10.1542/peds.2014-2299.

    PubMed 25266430

  • Healthy People 2020. Family Planning, Adolescent Health. 2014; https://www.healthypeople.gov/2020, 2017.

  • Society for Adolescent Health and Medicine; Burke PJ, Coles MS, Di Meglio G, Gibson EJ, Handschin SM, Lau M, Marcell AV, Tebb KP, Urbach K. Sexual and reproductive health care: a position paper of the Society for Adolescent Health and Medicine. J Adolesc Health. 2014 Apr;54(4):491-6. doi: 10.1016/j.jadohealth.2014.01.010. No abstract available.

    PubMed 24656535

  • Chernick LS, Schnall R, Higgins T, Stockwell MS, Castano PM, Santelli J, Dayan PS. Barriers to and enablers of contraceptive use among adolescent females and their interest in an emergency department based intervention. Contraception. 2015 Mar;91(3):217-25. doi: 10.1016/j.contraception.2014.12.003. Epub 2014 Dec 12.

    PubMed 25499588

  • Chernick LS, Westhoff C, Ray M, Garcia M, Garth J, Santelli J, Dayan PS. Enhancing referral of sexually active adolescent females from the emergency department to family planning. J Womens Health (Larchmt). 2015 Apr;24(4):324-8. doi: 10.1089/jwh.2014.4994.

    PubMed 25860108

  • Ahmad FA, Jeffe DB, Plax K, Collins KK, Schechtman KB, Doerhoff DE, Garbutt J, Jaffe DM. Computerized self-interviews improve Chlamydia and gonorrhea testing among youth in the emergency department. Ann Emerg Med. 2014 Oct;64(4):376-84. doi: 10.1016/j.annemergmed.2014.01.031. Epub 2014 Mar 6.

    PubMed 24612901

  • Ahmad FA, Jeffe DB, Plax K, Schechtman KB, Doerhoff DE, Garbutt JM, Jaffe DM. Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department. Emerg Med J. 2018 Jan;35(1):46-51. doi: 10.1136/emermed-2016-206199. Epub 2017 Aug 11.

    PubMed 28801483

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Contraception and Contraception Behavior, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initiation of contraception in the ED using the electronic application (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03559634, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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