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Contraceptive Pathway and Contraception Continuation Rates

Impact of a Contraceptive Pathway on Contraception Continuation Rates

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03925116
Enrollment
400
Registered
2019-04-23
Start date
2023-01-03
Completion date
2024-06-30
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage

Keywords

contraceptive pathway, continuation

Brief summary

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.

Interventions

OTHERCOntraceptive pathway

alternative way of aiding patients in deciding contraception method

Sponsors

Bayer
CollaboratorINDUSTRY
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

randomized

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Women at risk for pregnancy * Women able to read and write in English

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Continued Use of Contraception at 1 year1 yearThe 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

Secondary

MeasureTime frameDescription
Subject satisfaction with contraceptive counselingat initial office visit/immediateSubjects 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
Pregnancy rates1 yearAt each phone call, interval pregnancy rates will be collected and compared between subjects in the Contraceptive pathway vs usual care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026