The Impact of the SPIKES Protocol With IVF Patients

• Sponsor: Boston IVF (Other)
• Overall Status: Completed
• CT.gov ID: NCT04917445
• Collaborator: Weill Medical College of Cornell University (Other)
• Enrollment: 136
• Locations: 2
• Arms: 2
• Actual Duration (Months): 11.2
• Patients Per Site: 68
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Behavioral: Spikes-focused bad news protocol	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
• Actual Study Start Date: Jun 17, 2021
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: May 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPIKES Protocol Compassionate Call 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 trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
No Intervention: Control: Standard of Care Call Nurses who will continue to deliver bad news as they have been in the past without a script.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston IVF	Waltham	Massachusetts	United States	02451
2	Weill Cornell Medical Center Division of Reproductive Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Boston IVF
• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Alice Domar, PhD, Boston IVF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alice Domar, Executive Director of Domar Center for Mind Body Health, Boston IVF
• ClinicalTrials.gov Identifier: NCT04917445
• Other Study ID Numbers: BN2021
• First Posted: Jun 8, 2021
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alice Domar, Executive Director of Domar Center for Mind Body Health, Boston IVF: infertility; IVF; Spikes protocol
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of May 26, 2022