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The Impact of the SPIKES Protocol With IVF Patients

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spikes-focused bad news protocol
Sponsored by
Boston IVF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring infertility, IVF, Spikes protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Boston IVF
  • Weill Cornell Medical Center Division of Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SPIKES Protocol Compassionate Call

Control: Standard of Care Call

Arm Description

Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.

Nurses who will continue to deliver bad news as they have been in the past without a script.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2021
Last Updated
May 24, 2022
Sponsor
Boston IVF
Collaborators
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04917445
Brief Title
The Impact of the SPIKES Protocol With IVF Patients
Official Title
A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston IVF
Collaborators
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, IVF, Spikes protocol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPIKES Protocol Compassionate Call
Arm Type
Experimental
Arm Description
Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.
Arm Title
Control: Standard of Care Call
Arm Type
No Intervention
Arm Description
Nurses who will continue to deliver bad news as they have been in the past without a script.
Intervention Type
Behavioral
Intervention Name(s)
Spikes-focused bad news protocol
Intervention Description
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
Primary Outcome Measure Information:
Title
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
Description
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
Title
Assess patient distress after receiving the negative pregnancy test phone call
Description
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
Title
Assess patient depression after receiving the negative pregnancy test phone call
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Domar, PhD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Weill Cornell Medical Center Division of Reproductive Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Impact of the SPIKES Protocol With IVF Patients

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