Contraceptive UsageNCT03925116
Contraceptive Pathway and Contraception Continuation Rates
A study testing COntraceptive pathway in people with Contraceptive Usage, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway" Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- COntraceptive pathway
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women at risk for pregnancy
- Women able to read and write in English
Who cannot join
- Women who have undergone permanent sterilization
- Women not sexually active with a male partner
- Women who intend to become pregnant in the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Academic Building. 125 Paterson Street
New Brunswick, New Jersey, 08901
About this study
Official title: Impact of a Contraceptive Pathway on Contraception Continuation Rates
Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"
Read the detailed description
Patients who present to the gynecology clinic for an annual, postpartum or contraceptive visit will be asked if they are interested in obtaining contraception by the front desk staff. If they respond yes, they will be seen in a triage or exam room by study personnel/medical assistant (MA) who will ask them if they would like to participate in the study, review the study and then randomize them to either the contraceptive pathway or usual care. The randomization will be done by opening sequentially numbered envelopes once they consent and while in the triage/exam room.
Patients triaged to the pathway will be handed an electronic tablet questionnaire while they are waiting to see the physician/(Advanced practice nurse (APN). The tablet contains a link to bedside.org, a public website which reviews contraceptive options. Vital signs will be collected as per usual care and recorded on both the questionnaire and in the electronic medical record(EMR). Study personnel will be available to offer the patient additional information on their choice of contraception or assist them with the link for information. The completed survey will be printed and placed in the subject room for review by the physician/APN. A copy will be kept in the subject binder and another will be scanned into the EMR.
Patients triaged to usual care will wait for their physician without the pathway questionnaire and will be asked the usual questions by the MA which will be recorded in the EMR. Vital signs will be collected and recorded in the EMR.
The physician/APN will see the subject as usual, review either the questionnaire or the EMR, review contraception options and initiate the contraception.
At completion of the visit, all woman will be asked if she would complete a satisfaction survey for her visit. She will be called at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.
- Conditions
- Contraceptive Usage
- Being tested
- COntraceptive pathway
- Keywords
- contraceptive pathway, continuation
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COntraceptive pathwayOther
alternative way of aiding patients in deciding contraception method
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | women who present for birth control to the gynecology office will see their physician in the usual fashion for review, counseling and contraception decision/initiation. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. |
| Contraceptive pathway | Experimental | Women who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will:
1. collect relevant medical history
2. provide educational material on birth control options
3. provide a link to bedsider.com for further information
They will then discuss the tablet information/history with the medical assistant, who will answer any remaining questions. They will then see the physician/APN.
Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. Receives: Other: COntraceptive pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continued Use of Contraception at 1 year
The difference in contraception continuation rates will be compared between the Contraceptive Pathway group and the Usual care group, based on follow up phone calls at 3 weeks, 6 months and 1 year
Measured: 1 year
Secondary outcomes (2)
Subject satisfaction with contraceptive counseling
Subjects will complete a Likert scale 1 - 5 with 1 being most and 5 being least satisfied with the contraceptive counseling. Responses will be compared between the Contraceptive Pathway and Usual care group
Measured: at initial office visit/immediate
Pregnancy rates
At each phone call, interval pregnancy rates will be collected and compared between subjects in the Contraceptive pathway vs usual care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start3 Jan 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: budget
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
- Model description
- randomized
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Adrian C Balica, MD, Rutgers, The State University of New Jersey
- Investigators
- Adrian C Balica, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925116
- Sponsor's protocol ID
- Pro2018002901
- Status last verified
- May 2022
- First submitted
- 26 Mar 2019
- Last updated
- 6 May 2022
- 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Contraceptive Pathway on Contraception Continuation Rates
- ClinicalTrials.gov ID
- NCT03925116
- Acronym / sponsor ID
- Pro2018002901
- Conditions
- Contraceptive Usage
- Keywords
- contraceptive pathway, continuation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: budget
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 3 Jan 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 Apr 2019 (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.
Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"
Detailed description
Patients who present to the gynecology clinic for an annual, postpartum or contraceptive visit will be asked if they are interested in obtaining contraception by the front desk staff. If they respond yes, they will be seen in a triage or exam room by study personnel/medical assistant (MA) who will ask them if they would like to participate in the study, review the study and then randomize them to either the contraceptive pathway or usual care. The randomization will be done by opening sequentially numbered envelopes once they consent and while in the triage/exam room.
Patients triaged to the pathway will be handed an electronic tablet questionnaire while they are waiting to see the physician/(Advanced practice nurse (APN). The tablet contains a link to bedside.org, a public website which reviews contraceptive options. Vital signs will be collected as per usual care and recorded on both the questionnaire and in the electronic medical record(EMR). Study personnel will be available to offer the patient additional information on their choice of contraception or assist them with the link for information. The completed survey will be printed and placed in the subject room for review by the physician/APN. A copy will be kept in the subject binder and another will be scanned into the EMR.
Patients triaged to usual care will wait for their physician without the pathway questionnaire and will be asked the usual questions by the MA which will be recorded in the EMR. Vital signs will be collected and recorded in the EMR.
The physician/APN will see the subject as usual, review either the questionnaire or the EMR, review contraception options and initiate the contraception.
At completion of the visit, all woman will be asked if she would complete a satisfaction survey for her visit. She will be called at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –women who present for birth control to the gynecology office will see their physician in the usual fashion for review, counseling and contraception decision/initiation. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. |
| Contraceptive pathway | Experimental | Other: COntraceptive pathwayWomen who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will: 1. collect relevant medical history 2. provide educational material on birth control options 3. provide a link to bedsider.com for further information They will then discuss the tablet information/history with the medical assistant, who will answer any remaining questions. They will then see the physician/APN. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women at risk for pregnancy
- Women able to read and write in English
Key exclusion criteria (3 listed)
- Women who have undergone permanent sterilization
- Women not sexually active with a male partner
- Women who intend to become pregnant in the next 12 months
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 |
|---|---|---|
| COntraceptive pathwayalternative way of aiding patients in deciding contraception method | Other | Contraceptive pathway |
Primary outcome
Continued Use of Contraception at 1 year
Time frame: 1 year
The difference in contraception continuation rates will be compared between the Contraceptive Pathway group and the Usual care group, based on follow up phone calls at 3 weeks, 6 months and 1 year
2 secondary outcomes
Subject satisfaction with contraceptive counseling
Time frame: at initial office visit/immediate
Pregnancy rates
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- public website with contraceptive informationLink provided by the sponsor.
- 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.
Adrian C Balica, MD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COntraceptive pathway in people with Contraceptive Usage, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Continued Use of Contraception at 1 year (time frame: 1 year). 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 6 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.