Contraceptive Pathway and Contraception Continuation Rates

Contraceptive Usage Clinical Trial

Official title:

Impact of a Contraceptive Pathway on Contraception Continuation Rates

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03925116
• Other study ID #: Pro2018002901
• Status: Suspended
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Other:
• COntraceptive pathway
alternative way of aiding patients in deciding contraception method

Locations

Country	Name	City	State
United States	Clinical Academic Building. 125 Paterson Street	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	at initial office visit/immediate
Secondary	Pregnancy rates	At each phone call, interval pregnancy rates will be collected and compared between subjects in the Contraceptive pathway vs usual care	1 year

External Links

•   public website with contraceptive information