Contraceptive UsageNCT04882137
Barriers to Referring Adolescent Women for Etonogestrel Implant.
A study testing Education plus Coaching in people with Contraceptive Usage, run by Nemours Children's Clinic.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Education plus Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Contraceptive Usage
- Being tested
- Education plus Coaching
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education plus CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education plus Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of barriers to referral for etonogestrel implant based on questionnaire
Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant
Measured: 6 months
Number of adolescent women referred
Number of adolescent women who were referred for etonogestrel contraceptive implant
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 6 months
Aspects in Coaching that changed pediatric providers' behaviors
Qualitative analysis on which parts of coaching or standard intervention were most considered in referring.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Funding was stopped due to shifted research priorities by funder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Lonna Gordon, Nemours Children's Clinic
- Investigators
- Lonna P Gordon, MD, Principal investigator, Nemours Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882137
- Sponsor's protocol ID
- 1692814
- Status last verified
- Sep 2023
- First submitted
- 29 Apr 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04882137
- Acronym / sponsor ID
- 1692814
- Conditions
- Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was stopped due to shifted research priorities by funder
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Education plus CoachingPediatric 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education plus CoachingProviders 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. | Behavioural | Standard Education plus Coaching |
Primary outcome
Types of barriers to referral for etonogestrel implant based on questionnaire
Time frame: 6 months
Barriers to recommending and referring adolescent women for etonogestrel contraceptive implant
Number of adolescent women referred
Time frame: 18 months
Number of adolescent women who were referred for etonogestrel contraceptive implant
2 secondary outcomes
Categories of knowledge deficit in pediatric providers based on questionaire
Time frame: 6 months
Aspects in Coaching that changed pediatric providers' behaviors
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lonna P Gordon, MD principal investigator
Nemours Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Education plus Coaching in people with Contraceptive Usage, run by Nemours Children's Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types of barriers to referral for etonogestrel implant based on questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.