The Impact of the SPIKES Protocol With IVF Patients

Boston IVF136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

136

Conditions

Infertility

Interventions

Spikes-focused bad news protocolBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Boston IVF

Waltham, Massachusetts, United States

Weill Cornell Medical Center Division of Reproductive Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Within 48 hours of phone call

Data from ClinicalTrials.gov

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