Barriers to Referring Adolescent Women for Etonogestrel Implant.

NCT04882137 | Withdrawn

• 1 other identifier: 1692814
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (2)

• Types of barriers to referral for etonogestrel implant based on questionnaire

  Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant

  6 months

• Number of adolescent women referred

  Number of adolescent women who were referred for etonogestrel contraceptive implant

  18 months

Secondary Outcomes (2)

• Categories of knowledge deficit in pediatric providers based on questionaire

  6 months

• Aspects in Coaching that changed pediatric providers' behaviors

  18 months

Study Arms (2)

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.

Behavioral: Education plus Coaching

Interventions

Education plus Coaching BEHAVIORAL

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.

Standard Education plus Coaching

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Contraception Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Lonna P Gordon, MD

  Nemours Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Adolescent Medicine

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 11, 2021
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share