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WithdrawnNCT04882137Updated Sep 21, 2023

Barriers to Referring Adolescent Women for Etonogestrel Implant.

An interventional study of Education plus Coaching in Contraceptive Usage, sponsored by Nemours Children's Clinic. Withdrawn. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Funding was stopped due to shifted research priorities by funder
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
22 Years and older
Sex
All
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Study summary

This study seeks to understand how much pediatric providers in Central Florida know about the etonogestrel contraceptive implant. The investigators also seek to understand the barriers that may prevent them from referring adolescent women for this highly effective and recommended method of contraception. Finally the study will consider if an expanded education and coaching improves their ability to referring patients for this method of birth control.

Read the detailed description

This study is comprised of two phases. During the first phase 500 medical providers who provide care to adolescents will be recruited to complete a 30 question anonymous survey that evaluates their attitudes towards recommending and referring for adolescent women for the etonogestrel contraceptive device. This survey will also test participant's knowledge of indications, side effects and side effect management related to this contraceptive device as well.

During phase 2, 100 pediatric providers will be randomized to two groups. One group will receive standard continuing medical education on the use of the etonogestrel device in adolescents focusing on themes that emerged as knowledge deficits in phase 1. The other group will receive standard continuing medical education plus continued coaching on management of medication side effects. The referring patterns of physicians in each group will be studied.

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Conditions studied

  • Contraceptive Usage

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03

In context

Contraception Behavior

36 studies on the registry are indexed under Contraception Behavior; 13 are open to participants now.

Browse Contraception Behavior studies →

Lead sponsor

Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 27 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A primary care provider that cares for children under the age of 18. This includes physician's assistants, advanced nurse practitioners, residents or fellows, and physicians in pediatrics, internal medicine, and family medicine.
  • Must currently be practicing in Central Florida.
  • Be able to speak and write in English
  • For phase two of the study an additional requirement is that you must have a medical license to practice independently in the state of Florida.

Exclusion criteria

Exclusion Criteria:

  • Not a primary care provider who cares for children.
  • A pediatric provider who only provides specialty care
  • Not able to speak or write in English
  • For phase two of study does not have a medical license to practice independenly in the State of Florida.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    Standard Education

    Pediatric Providers in this arm will receive a continuing medical education on etonogestrel contractive implant but will not receive specialist coaching on how to manage side effects.

  • Experimental
    Standard Education plus Coaching

    Pediatric Providers in this arm will receive a continuing medical education program on etonogestrel contraceptive implant. Providers in this arm will also receive a tip-sheet on how to manage side effects as well as a number to directly access a specialist who places them if needed.

    Behavioral: Education plus Coaching

Interventions

  • BehavioralEducation plus Coaching

    Providers in Intervention group will receive standard education (1.5 hr CME), a tip sheet on how to manage side effects for quick reference and a number to directly reach a provider experienced with managing etonogestrel side effects with questions regarding how to manage side effects.

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What researchers measure

Primary outcomes

  1. Types of barriers to referral for etonogestrel implant based on questionnaire

    Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant

    Time frame: 6 months

  2. Number of adolescent women referred

    Number of adolescent women who were referred for etonogestrel contraceptive implant

    Time frame: 18 months

Secondary outcomes

  1. Categories of knowledge deficit in pediatric providers based on questionaire

    Understanding whether pediatric providers main knowledge deficit around etonogestrel implant is indications, side effects, or decreasing side effects.

    Time frame: 6 months

  2. Aspects in Coaching that changed pediatric providers' behaviors

    Qualitative analysis on which parts of coaching or standard intervention were most considered in referring.

    Time frame: 18 months

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Study protocol · Mar 31, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04882137
Responsible party
Lonna Gordon (Chief, Adolescent Medicine, Nemours Children's Clinic) — Principal investigator
First posted
May 11, 2021
Start date
Sep 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Sep 21, 2023

Study contacts

Lonna P Gordon, MD
principal investigator · Nemours Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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