The Impact of the SPIKES Protocol With IVF Patients

Infertility Clinical Trial

Official title:

A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917445
• Other study ID #: BN2021
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: May 24, 2022

Study information

• Verified date: May 2022
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 24, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Partners of patients undergoing treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Spikes-focused bad news protocol
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center Division of Reproductive Medicine	New York	New York
United States	Boston IVF	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston IVF	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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