Contraceptive Pathway and Contraception Continuation Rates

NCT ID: NCT03925116

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-06-30

Brief Summary

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

Detailed Description

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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

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Contraceptive Usage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Contraceptive pathway

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.

Group Type EXPERIMENTAL

COntraceptive pathway

Intervention Type OTHER

alternative way of aiding patients in deciding contraception method

Interventions

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COntraceptive pathway

alternative way of aiding patients in deciding contraception method

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Adrian C Balica, MD

Associate Professor, Dept. Ob/Gyn, RWJMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian C Balica, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Locations

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Clinical Academic Building. 125 Paterson Street

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://bedsider.com

public website with contraceptive information

Other Identifiers

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Pro2018002901

Identifier Type: -

Identifier Source: org_study_id

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