An interventional study of Spikes-focused bad news protocol in Infertility, sponsored by Boston IVF. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Boston IVF · Not applicable, Interventional, and Supportive care
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.
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.
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 136 is above the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Boston IVF is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.
Behavioral: Spikes-focused bad news protocol
Nurses who will continue to deliver bad news as they have been in the past without a script.
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
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.
Time frame: Within 48 hours of phone call
Assess patient distress after receiving the negative pregnancy test 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.
Time frame: Within 48 hours of phone call
Assess patient depression after receiving the negative pregnancy test 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.
Time frame: Within 48 hours of phone call
Ran from Jun 2021 to primary completion in Mar 2022, 9 months.
Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 9 months is below that.
Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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