Impact of a Contraceptive Pathway on Contraception Continuation Rates

Contraceptive Pathway and Contraception Continuation Rates

Sponsors

Lead sponsor: Rutgers, The State University of New Jersey

Collaborator: Bayer

Source Rutgers, The State University of New Jersey
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.

Overall Status Recruiting
Start Date January 3, 2020
Completion Date June 2021
Primary Completion Date June 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Continued Use of Contraception at 1 year 1 year
Secondary Outcome
Measure Time Frame
Subject satisfaction with contraceptive counseling at initial office visit/immediate
Pregnancy rates 1 year
Enrollment 400
Condition
Intervention

Intervention type: Other

Intervention name: COntraceptive pathway

Description: alternative way of aiding patients in deciding contraception method

Arm group label: Contraceptive pathway

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

Gender: Female

Minimum age: 18 Years

Maximum age: 49 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Adrian C Balica, MD Principal Investigator Rutgers Robert Wood Johnson Medical School
Overall Contact

Last name: Adrian C Balica, MD

Phone: 7322357755

Email: [email protected]

Location
facility status contact Clinical Academic Building. 125 Paterson Street Adrian Balica, MD 732-235-7321 [email protected]
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Rutgers, The State University of New Jersey

Investigator full name: Adrian C Balica, MD

Investigator title: Associate Professor, Dept. Ob/Gyn, RWJMS

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: usual care

Arm group type: No Intervention

Description: 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.

Arm group label: Contraceptive pathway

Arm group type: Experimental

Description: Women who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will: collect relevant medical history provide educational material on birth control options 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: randomized

Primary purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov