The Impact of the SPIKES Protocol With IVF Patients
- Conditions
- Infertility
- Interventions
- Behavioral: Spikes-focused bad news protocol
- Registration Number
- NCT04917445
- Lead Sponsor
- Boston IVF
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 136
- Female
- Age >18
- 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
- Partners of patients undergoing treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPIKES Protocol Compassionate Call Spikes-focused bad news protocol Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.
- Primary Outcome Measures
Name Time Method Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Weill Cornell Medical Center Division of Reproductive Medicine
🇺🇸New York, New York, United States
Boston IVF
🇺🇸Waltham, Massachusetts, United States