减少青少年怀孕
2023年1月31日 更新者：Children's Hospital of Philadelphia
以急诊科为基础的减少青少年怀孕的研究
这项多地点研究在急诊科 (ED) 中采用简短的避孕咨询干预措施，以阐明影响决策制定的因素以及在急诊科 (ED) 环境中启动受孕的障碍和促进因素。
该研究的总体目标是减少到急诊室 (ED) 就诊的 15 至 18 岁女性的意外怀孕。
研究概览
详细说明
这项研究是一项前瞻性队列研究，涉及到两个急诊科 (ED) 之一就诊的 16 至 18 岁女性，她们有意外怀孕的风险。
我们的主要目标是评估接受急诊科避孕药具的 15 至 18 岁女性开始避孕的意愿（“高”=非常/有点可能 vs“低”=不确定/不太可能/绝对不是）辅导。
我们的次要目标如下：
- 在同一人群中，评估任何避孕护理转诊的完成情况，定义为在首次 ED 就诊后 4 周内到转诊地点就诊。
- 通过电子病历文件（即访问记录、程序记录、药物审查）和参与者报告（跟进电话）评估最终开始避孕的比例。
- 使用定性访谈方法探索影响以下决定的态度、障碍和促进因素：A) 表达开始避孕的意图，B) 完成避孕护理转介，以及 C) 最终在这一独特的高危青少年群体中开始避孕。
研究类型
介入性
注册 (实际的)
144
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Kansas City、Missouri、美国、64108
- Children's Mercy Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 18年 (成人、孩子)
接受健康志愿者
是的
有资格学习的性别
女性
描述
纳入标准：
- 年龄在 15-18 岁且处于高怀孕风险的女性，定义为过去 6 个月内的性活动或未来可能的性活动。
- 明年内不希望怀孕的女性。
- 符合条件的个人必须精通英语口语和阅读。
- 青少年的同意。
排除标准：
- 目前正在使用激素避孕或宫内节育器的女性。
- 怀孕的女性。
- 患者发育迟缓限制了参与。
- 患者在性侵犯后出现在急诊室。
- 患者病情严重，无法进行筛查。
APPs: [无年龄限制]] 已在 ED 工作 6 个月
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：北美
- 介入模型：单组
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：咨询干预
所有参与者都将接受研究高级实践提供者 (APP) 提供的避孕咨询
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每位参与者都将在急诊科接受 10 分钟的保密避孕咨询课程
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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打算开始避孕
大体时间：长达 8 周
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打算在急诊室 (ED) 开始避孕或根据调查答复进行随访
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长达 8 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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避孕护理转介完成
大体时间：长达 8 周
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参与者完成了任何避孕护理的转诊
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长达 8 周
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开始避孕
大体时间：长达 12 周
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通过电子病历查看和后续电话或调查证明参与者已开始避孕
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长达 12 周
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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影响决策的独特主题数量
大体时间：长达 12 周
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使用扎根理论进行半结构化访谈并进行分析，以阐明影响避孕开始决策的因素。 只有一部分登记的青少年参加了可选的访谈（28 名参与者）。 因素基于称为 eTPB 的理论框架，计划行为的生态扩展理论，依靠态度、主观规范、社区、医疗保健和感知行为控制因素来解释行为。 访谈分析产生了以下因素：对避孕副作用和安全性的担忧、以往的避孕经验、使用避孕的原因、同伴、家庭和伴侣的影响、社交媒体、怀孕率以及获得避孕教育的机会、提供者的接触、对避孕的信心决策和知识，以及 ED 会话特征；所有上述因素都与 eTPB 的构造相对应。 |
长达 12 周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Cynthia J Mollen, MD, MSCE、Children's Hospital of Philadelphia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Chernick LS, Schnall R, Higgins T, Stockwell MS, Castano PM, Santelli J, Dayan PS. Barriers to and enablers of contraceptive use among adolescent females and their interest in an emergency department based intervention. Contraception. 2015 Mar;91(3):217-25. doi: 10.1016/j.contraception.2014.12.003. Epub 2014 Dec 12.
- Chernick LS, Westhoff C, Ray M, Garcia M, Garth J, Santelli J, Dayan PS. Enhancing referral of sexually active adolescent females from the emergency department to family planning. J Womens Health (Larchmt). 2015 Apr;24(4):324-8. doi: 10.1089/jwh.2014.4994.
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- Chernick L, Kharbanda EO, Santelli J, Dayan P. Identifying adolescent females at high risk of pregnancy in a pediatric emergency department. J Adolesc Health. 2012 Aug;51(2):171-8. doi: 10.1016/j.jadohealth.2011.11.023. Epub 2012 Apr 4.
- Miller MK, Pickett M, Leisner K, Sherman AK, Humiston SG. Sexual health behaviors, preferences for care, and use of health services among adolescents in pediatric emergency departments. Pediatr Emerg Care. 2013 Aug;29(8):907-11. doi: 10.1097/PEC.0b013e31829ec244.
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- Zuckerman B, Nathan S, Mate K. Preventing unintended pregnancy: a pediatric opportunity. Pediatrics. 2014 Feb;133(2):181-3. doi: 10.1542/peds.2013-1147. Epub 2014 Jan 27. No abstract available.
- Gordon JA, Billings J, Asplin BR, Rhodes KV. Safety net research in emergency medicine: proceedings of the Academic Emergency Medicine Consensus Conference on "The Unraveling Safety Net". Acad Emerg Med. 2001 Nov;8(11):1024-9. doi: 10.1111/j.1553-2712.2001.tb01110.x.
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- Hallfors DD, Iritani BJ, Miller WC, Bauer DJ. Sexual and drug behavior patterns and HIV and STD racial disparities: the need for new directions. Am J Public Health. 2007 Jan;97(1):125-32. doi: 10.2105/AJPH.2005.075747. Epub 2006 Nov 30.
- Miller MK, Randell KA, Barral R, Sherman AK, Miller E. Factors Associated With Interest in Same-Day Contraception Initiation Among Females in the Pediatric Emergency Department. J Adolesc Health. 2016 Feb;58(2):154-9. doi: 10.1016/j.jadohealth.2015.10.016.
- Miller MK, Champassak S, Goggin K, Kelly P, Dowd MD, Mollen CJ, et al. A brief intervention to reduce adolescent sexual risk behaviors: feasibility and impact. J Adolescent Health. 2014;54(2S):S11.
- Mollen CJ, Miller MK, Hayes KL, Wittink MN, Barg FK. Developing emergency department-based education about emergency contraception: adolescent preferences. Acad Emerg Med. 2013 Nov;20(11):1164-70. doi: 10.1111/acem.12243.
- Miller MK, Hornberger L, Sherman AK, Dowd MD. Acceptability of sexual health discussion and testing in the pediatric acute care setting. Pediatr Emerg Care. 2013 May;29(5):592-7. doi: 10.1097/PEC.0b013e31828e646f.
- Mehta SD, Hall J, Lyss SB, Skolnik PR, Pealer LN, Kharasch S. Adult and pediatric emergency department sexually transmitted disease and HIV screening: programmatic overview and outcomes. Acad Emerg Med. 2007 Mar;14(3):250-8. doi: 10.1197/j.aem.2006.10.106.
- Silva A, Glick NR, Lyss SB, Hutchinson AB, Gift TL, Pealer LN, Broussard D, Whitman S. Implementing an HIV and sexually transmitted disease screening program in an emergency department. Ann Emerg Med. 2007 May;49(5):564-72. doi: 10.1016/j.annemergmed.2006.09.028. Epub 2006 Nov 20.
- Trent M, Chung SE, Burke M, Walker A, Ellen JM. Results of a randomized controlled trial of a brief behavioral intervention for pelvic inflammatory disease in adolescents. J Pediatr Adolesc Gynecol. 2010 Apr;23(2):96-101. doi: 10.1016/j.jpag.2009.06.005. Epub 2009 Sep 3.
- Suffoletto B, Akers A, McGinnis KA, Calabria J, Wiesenfeld HC, Clark DB. A sex risk reduction text-message program for young adult females discharged from the emergency department. J Adolesc Health. 2013 Sep;53(3):387-93. doi: 10.1016/j.jadohealth.2013.04.006. Epub 2013 May 23.
- Calderon Y, Cowan E, Nickerson J, Mathew S, Fettig J, Rosenberg M, Brusalis C, Chou K, Leider J, Bauman L. Educational effectiveness of an HIV pretest video for adolescents: a randomized controlled trial. Pediatrics. 2011 May;127(5):911-6. doi: 10.1542/peds.2010-1443. Epub 2011 Apr 11.
- Mollen CJ, Miller MK, Hayes KL, Barg FK. Knowledge, attitudes, and beliefs about emergency contraception: a survey of female adolescents seeking care in the emergency department. Pediatr Emerg Care. 2013 Apr;29(4):469-74. doi: 10.1097/PEC.0b013e31828a3249.
- Miller MK, Mollen CJ, O'Malley D, Owens RL, Maliszewski GA, Goggin K, Kelly P. Providing adolescent sexual health care in the pediatric emergency department: views of health care providers. Pediatr Emerg Care. 2014 Feb;30(2):84-90. doi: 10.1097/PEC.0000000000000076.
- Miller MK, Plantz DM, Dowd MD, Mollen CJ, Reed J, Vaughn L, Gold MA. Pediatric emergency health care providers' knowledge, attitudes, and experiences regarding emergency contraception. Acad Emerg Med. 2011 Jun;18(6):605-12. doi: 10.1111/j.1553-2712.2011.01079.x.
- Reed JL, Punches BE, Taylor RG, Macaluso M, Alessandrini EA, Kahn JA. A Qualitative Analysis of Adolescent and Caregiver Acceptability of Universally Offered Gonorrhea and Chlamydia Screening in the Pediatric Emergency Department. Ann Emerg Med. 2017 Dec;70(6):787-796.e2. doi: 10.1016/j.annemergmed.2017.04.017. Epub 2017 May 27.
- Goyal MK, Teach SJ, Badolato GM, Trent M, Chamberlain JM. Universal Screening for Sexually Transmitted Infections among Asymptomatic Adolescents in an Urban Emergency Department: High Acceptance but Low Prevalence of Infection. J Pediatr. 2016 Apr;171:128-32. doi: 10.1016/j.jpeds.2016.01.019. Epub 2016 Feb 2.
- Mollen C, Lavelle J, Hawkins L, Ambrose C, Ruby B. Description of a novel pediatric emergency department-based HIV screening program for adolescents. AIDS Patient Care STDS. 2008 Jun;22(6):505-12. doi: 10.1089/apc.2007.0098.
- Cowan E, Leider J, Velastegui L, Wexler J, Velloza J, Calderon Y. A qualitative assessment of emergency department patients' knowledge, beliefs, attitudes, and acceptance toward revised HIV testing strategies. Acad Emerg Med. 2013 Mar;20(3):287-94. doi: 10.1111/acem.12090.
- Reed JL, Vaughn LM, Pomerantz WJ. Attitudes and knowledge regarding emergency contraception among emergency department adolescents and providers. Pediatr Emerg Care. 2012 Aug;28(8):775-9. doi: 10.1097/PEC.0b013e3182627d14.
- Office of Disease Prevention and Health Promotion. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/family-planning/objectives; Accessed December 12, 2017.
- National Institutes of Health. NICHD Research Priorities; https://www.nichd.nih.gov/grants-contracts/research-areas/priorities; Accessed January 4, 2018.
- National Center for Health Statistics. National Survey of Family Growth, 2013-2015. 2016; https://www.cdc.gov/nchs/nsfg/. Accessed January 15, 2018.
- Hoopes AJ, Benson SK, Howard HB, Morrison DM, Ko LK, Shafii T. Adolescent Perspectives on Patient-Provider Sexual Health Communication: A Qualitative Study. J Prim Care Community Health. 2017 Oct;8(4):332-337. doi: 10.1177/2150131917730210. Epub 2017 Sep 20.
- Kumar MM. Long-Acting Reversible Contraceptives for Adolescents: More Complex Than "First-Line". JAMA Pediatr. 2018 Jan 1;172(1):6-7. doi: 10.1001/jamapediatrics.2017.3520. No abstract available.
- Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1257-81. doi: 10.1542/peds.2014-2300.
- Madden T, Mullersman JL, Omvig KJ, Secura GM, Peipert JF. Structured contraceptive counseling provided by the Contraceptive CHOICE Project. Contraception. 2013 Aug;88(2):243-9. doi: 10.1016/j.contraception.2012.07.015. Epub 2012 Sep 5.
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- Mollen CJ, Barg FK, Hayes KL, Gotcsik M, Blades NM, Schwarz DF. Assessing attitudes about emergency contraception among urban, minority adolescent girls: an in-depth interview study. Pediatrics. 2008 Aug;122(2):e395-401. doi: 10.1542/peds.2008-0009.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月13日
初级完成 (实际的)
2021年2月17日
研究完成 (实际的)
2021年4月30日
研究注册日期
首次提交
2019年10月7日
首先提交符合 QC 标准的
2019年10月7日
首次发布 (实际的)
2019年10月9日
研究记录更新
最后更新发布 (实际的)
2023年2月3日
上次提交的符合 QC 标准的更新
2023年1月31日
最后验证
2023年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.