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Clinical Trials/NCT04882137
NCT04882137WithdrawnNot Applicable

A Study to Understand the Barriers in Referring Adolescent Women for the Etonogestrel Implant and to Evaluate Whether Intensive Coaching on the Management of Common Side Effects of the Implant Influences Referrals for the Implant.

Nemours Children's Clinic0 sitesStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Number of adolescent women referred

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •A primary care provider that cares for children under the age of
  • •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

  • •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.

Arms & Interventions

Standard Education

No Intervention

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.

Standard Education plus Coaching

Experimental

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.

Intervention: Education plus Coaching (Behavioral)

Outcomes

Primary Outcomes

Number of adolescent women referred

Time Frame: 18 months

Number of adolescent women who were referred for etonogestrel contraceptive implant

Types of barriers to referral for etonogestrel implant based on questionnaire

Time Frame: 6 months

Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant

Secondary Outcomes

  • Categories of knowledge deficit in pediatric providers based on questionaire(6 months)
  • Aspects in Coaching that changed pediatric providers' behaviors(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lonna Gordon

Chief, Adolescent Medicine

Nemours Children's Clinic

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