Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000576729
Ethics application status
Approved
Date submitted
29/03/2022
Date registered
19/04/2022
Date last updated
6/05/2022
Date data sharing statement initially provided
19/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of healthcare communication on medical decision-making
Scientific title
Online study investigating impact of anecdotal stories of In Vitro Fertilisation (IVF) success on medical decision-making in female volunteers
Secondary ID [1] 306800 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
in vitro fertilisation
 325867 0
Condition category
Condition code
Reproductive Health and Childbirth 323179 323179 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has two intervention arms and one control arm (so 3 arms in total), administered online using the Qualtrics survey software. The interventions will be delivered with paragraphs of text (hypothetical scenarios). The study will take approximately 15-20 minutes to complete.

Interventional materials: a hypothetical scenario of a visit to an IVF specialist after six unsuccessful attempts of IVF. participants are asked to imagine they are now trying to decide whether to continue or stop IVF treatment. The scenario details the cost of another round of IVF, the time taken off work for appointments, and the emotional and physical toll the process takes on participants and their partners. The participant is told they have less than 5% chance of success with another round.

Participants randomised to an intervention arm will then receive further information through anecdotal stories of success or failure. The two intervention arms consist of:

A hypothetical scenario with a positive anecdote of success against the odds, or
A hypothetical scenarios with both a positive and a negative anecdote (anecdote of failure)

In the positive anecdote scenario, the IVF specialist will describe a story about a couple in a similar situation who tried once more and had success.

In the paired positive and negative anecdote scenario, a story is told of a couple who had success with one more attempt, and of another couple who tried again for three more cycles and had no luck, with significant strain on their relationship and finances. The scenarios are included below:

Exact hypothetical scenario text:
Imagine that you have been undergoing in vitro fertilisation (IVF) with your partner for the past two years in attempts to conceive your first child. You have had six unsuccessful cycles to date, and are now trying to decide whether to continue or stop IVF treatment.

Although most of the cost is covered by Medicare, each cycle has an out-of-pocket cost of around $5000. Each cycle requires you to take some time off work for appointments (e.g. ultrasounds, egg collection, embryo transfers). Treatment has also had an emotional and physical toll, as well as strained your relationship with your partner. With each failed cycle, you feel like you lose a piece of yourself, but the only way to get those pieces back is by having a baby. Although this process is incredibly difficult, having a baby is something you have always wanted and imagined for yourself.

You have an appointment with your fertility specialist to discuss next steps. Your doctor says:

“Although IVF is a long-term process and failed attempts are part of the process, success is most likely within five to six attempts. As you have now had six cycles of IVF, your chances of success with another cycle are less than 5%.

Deciding to continue or stop is an incredibly difficult decision.

[Positive anecdote] I had a couple with six very similar cycle results to you. They were despairing that they hadn’t had a successful pregnancy yet and were trying to work out if it was worth continuing. They decided to give it another go – and got pregnant! They’ve now got baby Oliver and are so glad they kept trying.

[Paired positive and negative anecdotes] I’ve had two couples with six very similar cycle results to you. They were despairing that they hadn’t had a successful pregnancy yet, and were trying to work out if it was worth continuing. Both couples decided to give it another go - The first got pregnant! They’ve now got baby Oliver and are so glad they kept trying.
But the other couple went on to have a further three cycles but sadly still had no luck. They’ve since stopped trying due to the strain it placed on their relationship and finances.

I am happy to support you with whatever decision you decide.”

Adherence to and/or fidelity of the intervention will be monitored through access to Qualtrics analytic data. Implausibly fast response times will be deleted and attention check question is included to ensure participants are paying attention to the study.
Intervention code [1] 323261 0
Behaviour
Comparator / control treatment
One group will be the control group in which participants will read the same hypothetical scenario as described above, but no anecdote will be provided.

Participants randomised to the control arm will take a similar time to the intervention arms to complete the study (approx. 15 mins in total).
Control group
Active

Outcomes
Primary outcome [1] 330927 0
Intention to have another round of IVF

After reading intervention information participant is asked the question: “Imagining you were in this situation, would you have another cycle of IVF?”
- Scale 1-10, 1= ‘definitely will not’, 10= ‘definitely will’
“Please explain your answer above”
- Free text
Timepoint [1] 330927 0
Immediately after participants have read their respective intervention (hypothetical scenarios with no anecdote/positive anecdote/positive and negative anecdote)
Primary outcome [2] 330928 0
Worry (adapted from Scherer et al, 2017) “Imagining you were in this situation, how worried would you be about your chance of conceiving?”
- (7-point Likert scale (strongly disagree- strongly agree)).
Timepoint [2] 330928 0
Immediately after participants have read their respective hypothetical scenario
Primary outcome [3] 330929 0
Perceived likelihood of success (new item)
“On a scale from 0% to 100%, how likely do you think it is that you would be successful after another cycle of IVF?”
- Scale: 0% to 100% - slider
Timepoint [3] 330929 0
Immediately after participants have read their respective hypothetical scenario
Secondary outcome [1] 408112 0
Transportation scale-short form (Appel et al, 2015) Scoring: 7-point scale: 1 not at all to 7 very much, 7 answers averaged out to give one score
- “I could picture myself in the scene of the events described in the scenario”
- “I was mentally involved in the scenario while reading it”
- “I wanted to learn how the scenario ended”
- “The scenario affected me emotionally”
- “While reading the scenario I had a vivid image of the story setting”
- “While reading the scenario I had a vivid image of the couple who was successful”
- “While reading the scenario I had a vivid image of the couple who was unsuccessful”
Timepoint [1] 408112 0
Immediately after participants have read their respective intervention (no anecdote/positive anecdote/positive and negative anecdote)

Eligibility
Key inclusion criteria
Participants must be female, living in Australia, aged between 18-45 years
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
n/a

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to one of the three in conditions using Qualtrics survey software. The researchers and market research company recruiting participants will be unaware of the condition any participant is randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised automatically using the Randomizer function included in Qualtrics, which utilises the Mersenne Twister pseudorandom number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
179 individuals randomised to each group will provide 90% power to detect a main effect of randomised group (3 arms) for the main outcome of intention at an alpha level of 0.01. This sample size will also provide 90% power to detect pairwise differences between arms of 0.38SDs (corresponding to a 1 unit difference on the intention scale) at an adjusted alpha level of 0.025. Data will first be cleaned and checked for missing values, outliers, non-serious responders (bots, completion time less than one third of the median, nonsensical or rude responses to open ended questions). We will initially sample an additional ~20% of the required sample size to each randomised group (n=215 per group) to ensure an appropriate sample size after this process. We will use a series of regression models using SPSS Version 28.0 to test for main effects of randomised group in main and secondary outcomes. We will also conduct planned pairwise comparisons between arms for any significant differences in outcomes. We will also conduct sensitivity analyses to test the influence of participants with previous experience of IVF by inclusion as a covariate in the regression models.

Data will first be cleaned and checked for missing values, outliers, non-serious responders (bots, completion time less than one third of the median, nonsensical or rude responses to open ended questions). We will initially sample an additional ~20% of the required sample size to each randomised group (n=156 per group) to ensure an appropriate sample size after this process.

We will use a series of regression models using SPSS Version 28.0 to test for main effects of randomised group in main and secondary outcomes. We will also conduct planned pairwise comparisons between arms for any significant differences in outcomes.
We will also conduct sensitivity analyses to test the influence of participants with previous experience of IVF by inclusion as a covariate in the regression models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2022
Actual
Date of last participant enrolment
Anticipated
30/05/2022
Actual
Date of last data collection
Anticipated
30/05/2022
Actual
Sample size
Target
645
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311137 0
University
Name [1] 311137 0
Sydney School of Public Health, The University of Sydney, Fisher Road, Camperdown NSW 2006
Country [1] 311137 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, The University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
Fisher Road, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312564 0
None
Name [1] 312564 0
n/a
Address [1] 312564 0
n/a
Country [1] 312564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310663 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310663 0
Ethics committee country [1] 310663 0
Australia
Date submitted for ethics approval [1] 310663 0
24/02/2022
Approval date [1] 310663 0
27/04/2022
Ethics approval number [1] 310663 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118442 0
Dr Tessa Copp
Address 118442 0
Room 127A Edward Ford Building (A27)
The University of Sydney, Fisher Road, Camperdown NSW 2006
Country 118442 0
Australia
Phone 118442 0
+61 02 8627 7646
Fax 118442 0
Email 118442 0
[email protected]
Contact person for public queries
Name 118443 0
Verity Chadwick
Address 118443 0
Royal North Shore Hospital, Reserve St, St Leonards, 2065 NSW Australia
Country 118443 0
Australia
Phone 118443 0
+61 02 9926 7111
Fax 118443 0
Email 118443 0
[email protected]
Contact person for scientific queries
Name 118444 0
Tessa Copp
Address 118444 0
Room 127A Edward Ford Building (A27)
The University of Sydney, Fisher Road, Camperdown NSW 2006
Country 118444 0
Australia
Phone 118444 0
+61 02 9351 7220
Fax 118444 0
Email 118444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial can be made available in de-identified CSV or excel datasets, along with the data dictionary
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published for up to 5 years after publication
(query: data will be stored in perpetuity per ethics declaration)
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis
How or where can data be obtained?
Data will be made upon direct contact with the principal investigator. Contact details of the principal investigator are: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.