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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIKES Protocol Compassionate Call | Experimental | Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script. |
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| Control: Standard of Care Call | No Intervention | Nurses who will continue to deliver bad news as they have been in the past without a script. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spikes-focused bad news protocol | Behavioral | Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Within 48 hours of phone call |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice Domar, PhD | Boston IVF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston IVF | Waltham | Massachusetts | 02451 | United States | ||
| Weill Cornell Medical Center Division of Reproductive Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39026124 | Derived | Domar AD, Korkidakis A, Bortoletto P, Gulrajani N, Khodakhah D, Rooney KL, Gompers A, Hacker MR, Grill E. The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial. J Assist Reprod Genet. 2024 Sep;41(9):2367-2377. doi: 10.1007/s10815-024-03198-3. Epub 2024 Jul 19. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| New York |
| New York |
| 10065 |
| United States |