Clinical trial NCT04882137: Barriers to Referring Adolescent Women for Etonogestrel Implant.
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contraceptive Usage
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Types of barriers to referral for etonogestrel implant based on questionnaire
timeFrame: 6 months
measure: Number of adolescent women referred
timeFrame: 18 months
Secondary outcomes:
measure: Categories of knowledge deficit in pediatric providers based on questionaire
timeFrame: 6 months
measure: Aspects in Coaching that changed pediatric providers' behaviors
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Nemours Children's Hospital
name: Lonna P Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References: