The Impact of the SPIKES Protocol With IVF Patients

Boston IVF

Status: Completed

Conditions: Infertility

Treatments: Behavioral: Spikes-focused bad news protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04917445

BN2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

SPIKES Protocol Compassionate Call

Experimental group

Description:

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

Treatment:

Behavioral: Spikes-focused bad news protocol

Control: Standard of Care Call

No Intervention group

Description:

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