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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

  • Assisted Reproduction Technologies
  • Published:
Journal of Assisted Reproduction and Genetics Aims and scope Submit manuscript

Abstract

Purpose

Determine if the SPIKES method was associated with less distress and more compassion than current modes of delivering negative pregnancy test results to patients undergoing in vitro fertilization.

Methods

Twenty-seven nurses from two centers were randomized to use the modified SPIKES script or continue their standard of care; 136 patients with a negative hCG following embryo transfer were included. SPIKES nurses received 1 h of training by a study psychologist; nurses in the control group were instructed to deliver the news as done previously. Patients who underwent embryo transfer and received a call by a participating nurse with a negative test result received an email invitation on the following day.

Results

Control patients reported significantly less distress than SPIKES patients; 33% of SPIKES patients reported that they had felt “extremely sad,” compared to 15.2% of the control patients (p = 0.01). Perceived compassion did not differ between the groups (all p ≥ 0.22).

Conclusion

Patients who received a negative pregnancy test result from the nurses who received a brief training and a script on how to deliver bad news via the modified SPIKES protocol reported significantly more distress than patients receiving negative results from nurses utilizing their standard of care. It is unclear whether a modified SPIKES method to deliver negative pregnancy test results will benefit patients undergoing in vitro fertilization.

Trial registration

Clinical trials.gov NCT04917445.

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Data can be available upon request.

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Acknowledgements

The authors would like to thank Sharon Edwards, RN, BSN, and Susan Gordon-Pinnell, RN, BSN, for their assistance with nursing recruitment at Boston IVF. The authors would also like to thank Schuyler Awtrey for her assistance with the preparation of this manuscript.

Funding

This study was funded by the Domar Foundation as well as support from Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR002541) and financial contributions from Harvard University and its affiliated academic healthcare centers.

Author information

Authors and Affiliations

  1. Inception Fertility, Inception Research Institute, 4828 Loop Central Drive, Houston, TX, 77081, USA

    A. D. Domar

  2. Boston IVF, 130 Second Avenue, Waltham, MA, 02451, USA

    A. Korkidakis, P. Bortoletto, N. Gulrajani, D. Khodakhah & K. L. Rooney

  3. Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA

    A. D. Domar, A. Korkidakis, P. Bortoletto, A. Gompers & M. R. Hacker

  4. Weill Cornell Center for Reproductive Medicine, 1305 York Avenue, New York, NY, 10021, USA

    E. Grill

Authors
  1. A. D. Domar
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  6. K. L. Rooney
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Contributions

Drs. Domar, Korkidakis, Bortoletto, and Grill participated in study design, execution, analysis, manuscript drafting, and critical discussion. Dr. Hacker and Ms. Gompers participated in study design, analysis, manuscript drafting, and critical discussion. Ms. Gulrajani and Ms. Khodakhah participated in execution, manuscript drafting, and critical discussion. Ms. Rooney participated in study design, execution, manuscript drafting, and critical discussion.

Corresponding author

Correspondence to A. D. Domar.

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Appendices

Appendix 1. SPIKES script

Hi this is [nurse full name], one of the IVF nurses at Cornell/Boston IVF.

May I please speak with [patient full name]

Is now a good time to talk about your test results?

If no

When would be a good time to call back?

If yes

Before we review the results, is there anyone else you would like to add to the call?

Delivery:

Have you taken a home pregnancy test before getting your results today?

If yes

Unfortunately, the blood work confirmed that you are not pregnant. I am so sorry I know this is not the result you hoped for.

If no

I am so sorry to have to share this information with you. Your pregnancy test came back negative. I know this is not the result you hoped for.

Questions

Would you like to know all of the details such as your beta hCG level or would you prefer to take time to digest the information?

If yes

(Give test results & proceed to “if no” step below)

If no

I know this is disappointing information—what questions do you have so far?

Checking in with patient

How are you doing?

How are you feeling?

It is understandable that you are feeling [whatever feeling patient expressed].

I can see how upsetting this is to you and I wish the news were better.

Next Steps

[Discuss next steps with patient – including what to do about medication and setting up follow-up time with their doctor].

I’m sure you will think of many more questions.

When you do, write them down and you can review them with our doctor during your follow up appointment or feel free to reach out to me.

Wrap Up

Before I go, do you have someone to talk to and support you after we hang up?

You don’t have to deal with this alone. We have counselors on staff who can help you process this information and support you.

We have a whole team on your side to help with next steps when and if you are ready.

Okay, bye [patient first name].

Appendix 2

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Appendix 3. Email invite to patients

Dear [insert patient name],

We are constantly working to make your care here as patient-centered as possible. One of the aspects of care that we are contemplating changing is the way that the news of a negative pregnancy test is delivered.

Would you be willing to complete two brief research questionnaires? All answers are completely anonymous and non-identifying, neither your physician nor nurse will know that you completed this questionnaire.

Your answers will be used to help study the most compassionate way to deliver disappointing information.

If you agree to support us in this quick research project, please click on this link: [insert link].

Thank you,

Research Assistant

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Domar, A.D., Korkidakis, A., Bortoletto, P. et al. 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 41, 2367–2377 (2024). https://doi.org/10.1007/s10815-024-03198-3

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  • DOI: https://doi.org/10.1007/s10815-024-03198-3

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