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临床试验/NCT03925116
NCT03925116暂停不适用

Impact of a Contraceptive Pathway on Contraception Continuation Rates

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
400
试验地点
2
主要终点
Continued Use of Contraception at 1 year

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Continued Use of Contraception at 1 year

时间窗: 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

次要结局

  • Pregnancy rates(1 year)
  • Subject satisfaction with contraceptive counseling(at initial office visit/immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian C Balica, MD

Associate Professor, Dept. Ob/Gyn, RWJMS

Rutgers, The State University of New Jersey

研究点 (2)

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