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临床试验/NCT03383848
NCT03383848已完成不适用

Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment

University of Michigan4 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
4
主要终点
Documented Medication Errors

研究概览

简要总结

This study will evaluate if an electronic medication management software solution can improve outcomes for patients undergoing in vitro fertilization (IVF) treatment. Participants will be randomized equally into two groups: half will use the management software, while the other half will act as a control group.

详细描述

In the United States, individuals suffering from infertility pursued approximately 190,000 cycles of in vitro fertilization (IVF) in 2014, with approximately 1.5 million cycles performed internationally. Without insurance coverage, each cycle can cost between $15,000 and $25,000 for medications and procedures. The goal of an IVF cycle is a healthy baby, but to achieve this goal, patients and their partners are asked to manage administration and inventory of between 6 and 12 medications with doses and routes that can change daily. Due to the complexity of the treatment and the fact that the medications are expensive and ordered by patients incrementally to reduce large amounts of waste, medication errors (wrong dose; missed dose; running out of medication) are common (3-15% of patients).

The current standard is that patients manage this process of medication inventory, administration, and refills on their own with their own systems, using paper calendars provided by a clinic (which are immediately inaccurate once the cycle starts), paper-and-pencil lists, electronic lists, or generic medication-tracking applications, combined with verbal and written reminders from their clinic. Not having the right medication at the right time is the most critical error, and with the current methods, the patient often does not realize this fact while there is sufficient time to rectify the inventory problem, and the clinic has no way to catch at-risk patients proactively. For these patients, this error can mean a sub-optimal response with a lower chance of pregnancy that particular month (as low as 0%, depending on the error). Of the patients undergoing IVF with perfect adherence, only about 50% achieve the goal of a healthy baby. For the remainder, there will always be the concern that perhaps they could have had a different outcome, and for those with a medication error, they will never know whether the outcome could have been different if that error had not occurred.

This study will determine if patients using medication management software will have lower numbers of documented medication errors (as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle) compared to patients who use standard paper/pencil or home-grown methods to track their medication inventory.

研究设计

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

入排标准

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

入选标准

  • Women undergoing IVF cycle (planning egg retrieval) at University of Michigan, for any indication (infertility, fertility preservation, or genetic disorder planning preimplantation genetic screening or diagnosis)
  • English as primary language
  • Owns a smartphone
  • Owns a non-smartphone device with access to the internet at home (tablet, laptop computer, or desktop computer)
  • Has internet access at home

排除标准

  • Non-English speaker as primary language
  • Previous participant in same study
  • Not undergoing IVF fertility treatment
  • Does not own a smartphone
  • Does not own a tablet, laptop computer, or desktop computer
  • Does not have internet access at home

结局指标

主要结局

Documented Medication Errors

时间窗: End of treatment cycle, between day 9 and day 15

Common medication errors such as wrong dose, missed dose, or running out of medication, as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle.

次要结局

  • Number of Phone and Patient Portal Messages to Infertility Nurses(End of treatment cycle, between day 9 and day 15)
  • Quantity of Medication Waste(End of treatment cycle, between day 9 and day 15)
  • Anxiety Level(Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle))
  • Quality of Life(Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle))
  • Stress Level(Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle))

研究者

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

Michael Lanham

Assistant Professor

University of Michigan

研究点 (4)

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