InfertilityNCT04917445
The Impact of the SPIKES Protocol With IVF Patients
A study testing Spikes-focused bad news protocol in people with Infertility, run by Boston IVF at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Spikes-focused bad news protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2021to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Partners of patients undergoing treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weill Cornell Medical Center Division of Reproductive Medicine
New York, New York, 10065
Boston IVF
Waltham, Massachusetts, 02451
About this study
Official title: A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Spikes-focused bad news protocol
- Keywords
- infertility, IVF, Spikes protocol
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spikes-focused bad news protocolBehavioural
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
| Study group | Role | What they receive |
|---|---|---|
| SPIKES Protocol Compassionate Call | Experimental | Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script. Receives: Behavioral: Spikes-focused bad news protocol |
| Control: Standard of Care Call | No intervention | Nurses who will continue to deliver bad news as they have been in the past without a script. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 48 hours of phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start17 Jun 2021
- Primary completion31 Mar 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Alice Domar, Boston IVF
- Investigators
- Alice Domar, PhD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917445
- Sponsor's protocol ID
- BN2021
- Status last verified
- May 2022
- First submitted
- 26 May 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Domar AD, Korkidakis A, Bortoletto P, Gulrajani N, Khodakhah D, Rooney KL, Gompers A, Hacker MR, Grill E. The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial. J Assist Reprod Genet. 2024 Sep;41(9):2367-2377. doi: 10.1007/s10815-024-03198-3. Epub 2024 Jul 19.
PubMed 39026124
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
- ClinicalTrials.gov ID
- NCT04917445
- Acronym / sponsor ID
- BN2021
- Conditions
- Infertility
- Keywords
- infertility, IVF, Spikes protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIKES Protocol Compassionate Call | Experimental | Behavioral: Spikes-focused bad news protocolNurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script. |
| Control: Standard of Care Call | No intervention | –Nurses who will continue to deliver bad news as they have been in the past without a script. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Partners of patients undergoing treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spikes-focused bad news protocolNurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients. | Behavioural | SPIKES Protocol Compassionate Call |
Primary outcome
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
Time frame: 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.
Assess patient distress after receiving the negative pregnancy test phone call
Time frame: 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.
Assess patient depression after receiving the negative pregnancy test phone call
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 39026124Domar AD, Korkidakis A, Bortoletto P, Gulrajani N, Khodakhah D, Rooney KL, Gompers A, Hacker MR, Grill E. The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial. J Assist Reprod Genet. 2024 Sep;41(9):2367-2377. doi: 10.1007/s10815-024-03198-3. Epub 2024 Jul 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Domar, PhD principal investigator
Boston IVF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spikes-focused bad news protocol in people with Infertility, run by Boston IVF at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion (time frame: Within 48 hours of phone call). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.