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Impact of Contraceptive Pathway

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ClinicalTrials.gov Identifier: NCT03925116
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Adrian C Balica, MD, Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment Phase
Contraceptive Usage Other: COntraceptive pathway Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Contraceptive Pathway on Contraception Continuation Rates
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
No Intervention: 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.

Experimental: 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.

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




Primary Outcome Measures :
  1. Continuation of contraception [ Time Frame: 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


Secondary Outcome Measures :
  1. Subject satisfaction [ Time Frame: at initial office visit/immediate ]
    The subject satisfation with contraceptive visit will be compared between Contraceptive Pathway and Usual Care groups based on an exit survey which will be administed at the end of the pateint visit.

  2. Pregnancy rates [ Time Frame: 1 year ]
    pregnancy rates in the usual versus pathway



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925116


Contacts
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Contact: Adrian C Balica, MD 7322357755 balicaac@rutgers.edu
Contact: Nancy A Phillips, MD 7322357755 phillina@rutgers.edu

Sponsors and Collaborators
Rutgers, The State University of New Jersey
Bayer
Investigators
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Principal Investigator: Adrian C Balica, MD Rutgers Robert Wood Johnson Medical School

Additional Information:
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Responsible Party: Adrian C Balica, MD, Associate Professor, Dept. Ob/Gyn, RWJMS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03925116     History of Changes
Other Study ID Numbers: Pro2018002901
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrian C Balica, MD, Rutgers, The State University of New Jersey:
contraceptive pathway, continuation

Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs