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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04882137
Other study ID # 1692814
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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