A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Boston IVF
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
研究概览
简要总结
The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.
详细描述
Presently, nurses at Boston IVF (BIVF) and Weill Cornell Medical Center Division of Reproductive Medicine (Cornell) do not have a scripted method to deliver negative pregnancy tests to in Vitro Fertilization (IVF) patients. This study will invite clinic nurses to assist in the research protocol; half of the nurses will be randomized to be trained on a compassionate way to deliver bad news following the SPIKES protocol, while the other half will continue with the current standard of care of news delivery. The patients who receive the negative test phone calls from participating nurses will be surveyed to see if the method of which the news was delivered was scored as more compassionate, as well as if it was associated with reduced participants reported level of distress and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Underwent an embryo or blastocyst transfer using their own eggs at participating clinic
- •Able to read and understand English
- •Access to email
- •Received a negative pregnancy test result phone call from a nurse involved in the research study
排除标准
- •Partners of patients undergoing treatment
结局指标
主要结局
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
时间窗: Within 48 hours of phone call
We revised the Communicating Bad News questionnaire which follows the SPIKES protocol, published by Gonzales-Cabrera et al. Their questionnaire had 25 items, Internal consistency was 0.816. The content validity was established via the Kaiser-Meyer-Olkin test (KMO) with a score of 0.683 and the Bartlett test of sphericity was p\<0.001. The principal component analysis supported a four dimension construct. There are 22 items rated 1, 2, 3 with a scoring range of 22-66. For the Compassion Assessment, there are 19 slots for the 5 categories so the scoring range is 5-95. The content validity was established via the Kaiser-Meyer-Olkin test (KMO) with a score of 0.683. and the Bartlett test of sphericity was p\<0.001. The principal component analysis supported a four dimension construct. There are 22 items rated 1,2,3 so the scoring range is 22-66. For the Compassion Assessment, there are 19 slots for the 5 categories so the scoring range is 5-95.
Assess patient depression after receiving the negative pregnancy test phone call
时间窗: Within 48 hours of phone call
We will use 5-point Likert scales to assess patient depression after receiving the negative pregnancy test phone call. The Likert scale range is 1-5.
Assess patient distress after receiving the negative pregnancy test phone call
时间窗: Within 48 hours of phone call
We will use 5-point Likert scales to assess patient distress after receiving the negative pregnancy test phone call. The Likert scale range is 1-5.
次要结局
未报告次要终点
研究者
Alice Domar
Executive Director of Domar Center for Mind Body Health
Boston IVF