Clinical trial NCT03925116: Contraceptive Pathway and Contraception Continuation Rates
Official title: Impact of a Contraceptive Pathway on Contraception Continuation Rates
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Contraceptive Usage
Keywords: contraceptive pathway
continuation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-04-23
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continued Use of Contraception at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Subject satisfaction with contraceptive counseling
timeFrame: at initial office visit/immediate
measure: Pregnancy rates
timeFrame: 1 year
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Clinical Academic Building. 125 Paterson Street
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Adrian C Balica, MD
role: PRINCIPAL_INVESTIGATOR
References: