Barriers to Referring Adolescent Women for Etonogestrel Implant.

Contraceptive Usage Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04882137
• Other study ID #: 1692814
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Behavioral:
• Education 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types of barriers to referral for etonogestrel implant based on questionnaire	Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant	6 months
Primary	Number of adolescent women referred	Number of adolescent women who were referred for etonogestrel contraceptive implant	18 months
Secondary	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.	6 months
Secondary	Aspects in Coaching that changed pediatric providers' behaviors	Qualitative analysis on which parts of coaching or standard intervention were most considered in referring.	18 months