Barriers to Referring Adolescent Women for Etonogestrel Implant.

NCT ID: NCT04882137

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Contraceptive Usage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard Education

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard Education plus Coaching

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.

Group Type EXPERIMENTAL

Education plus Coaching

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lonna Gordon

Chief, Adolescent Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lonna P Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Hospital

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1692814

Identifier Type: -

Identifier Source: org_study_id

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