Keywords
prenatal screening - decision aid - games - randomized controlled study - education
The American College of Obstetricians and Gynecologists (ACOG) recommends that prenatal
care providers offer all women prenatal screening in the first trimester of pregnancy,
regardless of age or genetic risk status.[1] This has moved the focus of prenatal screening from a subset of higher risk women
to all pregnant women. However, significant barriers remain for effectively informing
women about the risks and options for identifying and managing chromosomal anomalies
and heritable conditions during pregnancy. It is widely recognized that current standards
for patient education in this domain are largely ineffective.[2]
[3]
[4] This is due to several factors, including limited appointment time by clinicians,
the routinization of prenatal screening, lack of effective education interventions,
and the continued expansion of testing content and options. Decisions about prenatal
screening are based on pregnant women' values and knowledge and therefore clinicians
are often challenged with being informative but nondirective. As such, new and innovative
methods of promoting informed decision-making about prenatal screening among patients
are needed.
One approach for informing pregnant women about their options and outcomes of prenatal
screening is the use of decision aids.[5]
[6] Decision aids have been used in several medical contexts in which the treatment
choices are equivalent in their benefits (e.g., survival) but have differing risks.
Decision aids inform patients of their options, help clarify patient values, support
patients' decision process, and enable patients to engage more actively in shared
decision-making with their providers.[7] They are important in helping patients make decisions about available options that
involve trade-offs in terms of outcomes and knowledge during pregnancy.
Most decision aids still use brochures or didactic presentations and do not include
interactivity throughout the educational experience. Clinicians need innovative methods
to educate patients. As such, interactive games have a long-standing history as effective
interventions for learning and motivating health behavior.[8] This is because contrary to information on paper or through other applications delivered
on mobile devices or computers, games are generally not a one-time dissemination of
information. The interactive component can provide large amounts of didactic content
through unlimited opportunities to rehearse and personalize feedback associated with
a game. Furthermore, players can choose various simulated roles and choices to explore
different decisions on their own time even when the choices explored are value-laden
and morally significant as may be the case in the context of prenatal screening.[9]
[10] Also, games can increase personalization and relevance of an experience by providing
a range of outcomes for players to experience, thus making them ideal for real-life
health care decisions.[11]
[12]
[13] These features can significantly increase users' attention and retention of knowledge
compared with a brochure or pamphlet.
However, the nondirective nature of prenatal screening education poses significant
challenges for the game context. Games are often engaging through the provision of
rewards to the gamer for success in working through barriers and problems toward an
ultimate goal. In the health care domain, games can use such reward strategies to
promote knowledge and adherence to professional recommendations. In the context of
prenatal screening, the goal is not to either promote or inhibit prenatal screening
per se, rather they can also be used to promote informed decision-making, present
multiple options in a nondirective manner, clarify internal values, and promote communication
with providers. This makes them ideal for supporting patients facing complex decisions
for which the “correct” answer comes from a deeply personal decision-making process.
Specifically, these issues are important when making choices about noninvasive prenatal
screening. As such, the purpose of this research was to develop and evaluate the efficacy
of a game decision aid on knowledge and satisfaction about noninvasive prenatal screening
among pregnant women through a randomized controlled study.
Materials and Methods
The goal of this research was to develop and evaluate the efficacy of a game decision
aid intervention among pregnant women about knowledge on prenatal screening and satisfaction
with this type of decision aid. The project received Institutional Review Board approval
from the University of Utah (00080529).
Participants
Pregnant women were recruited from an obstetric (OB) clinic of an academic urban medical
center in the intermountain west. Eligibility criteria included being English speaking,
and less than 15 weeks' gestation and attending first OB visit for a low-risk pregnancy.
Procedures
Potentially eligible participants were approached immediately before their first prenatal
OB visit in the clinic waiting room. If they were interested in participating, eligible
participants were asked to arrive 30 minutes prior to their second OB visit. Consistent
with current guidelines,[1] the official policy at the recruitment site was to offer all women prenatal screening
regardless of age, family history, or other risk factors. Participants in both groups
were given the brochure-based decision aid during their first OB visit in the clinic
as part of routine care along with any physician communication, as per the practice
of the individual clinician.
Prior to randomization, all participants provided written informed consent. Participants
were then assigned based on the computer-generated simple randomization sequence to
the usual care or game intervention group. Upon completion of the study, participants
received a gift card. In the usual care group, participants were given the same brochure
as in the clinic to remind them of content. Participants were welcomed to review the
brochure as long as they liked before completing the surveys. After reviewing the
brochure, participants completed the surveys.
The game intervention group was given the same brochure and instructions as the control
group, but they were also asked to play for however long they wanted the game called
“The Meaning of Screening.” Participants then completed surveys after playing the
game.
Development of the Experimental Game Intervention
The brochure-based decision aid used in the clinic is based on ACOG guidelines. Using
the same content of the brochure, the game, “The Meaning of Screening,” was created
in collaboration with the Entertainment, Arts, and Engineering program at the University
of Utah. Initial focus groups (n = 3) with 22 pregnant women, their partners, and OB health or genetic counseling
professionals provided the initial data for development. Then, iterative team meetings
with game engineers, geneticists, obstetricians, nurse midwives, social scientists,
and health communication experts were then conducted to develop and implement the
game for this study. The game experience was driven by an exploration of risk estimates
for positive and negative screening outcomes and diagnostic testing outcomes by the
woman's maternal age. Participants were able to “click” through various age groups
of the pregnant avatars and see outcomes and likelihood of positive and negative results,
including false-positives and false-negatives from prenatal screening through diagnostic
testing outcomes ([Figs. 1] and [2]). As participants “clicked” through various outcomes, they were encouraged to have
the avatars talk to each other about facts and reasons for pursuing or not pursuing
prenatal screening. To address concerns regarding health literacy and numeracy, the
number of avatars was represented to reflect the actual risk of these outcomes. For
example, if there was a 1 in 100 chance of a false-positive, then 1 avatar was put
under that outcome and 100 avatars were placed on the other side of the screen. The
design layout of the game was pleasant, with bright colors and an agreeable outdoor
environment that included trees, grass, and a river.
Fig. 1 Pregnant women by age.
Fig. 2 Avatars.
Surveys
Participants in both groups completed a knowledge survey about prenatal screening
and diagnostic testing. Knowledge was measured with a 23-item survey (Prenatal Screening
Knowledge Survey) developed by an expert panel of genetic counselors, physicians,
social scientists, and data collection experts. Internal consistency was excellent
in our sample (N = 73) with a Cronbach's α = 0.78 (see [Supplementary Material] [available in the online version] for a list of questions).
The International Patient Aid Decision Aids Standards (IPDAS) Collaboration published
a checklist of the criteria that should be included in a well-designed decision aids.[14] Values clarification exercises were included as a critical component in the checklist.
Values clarification exercises are processes to aid patients in clarifying their values
and goals and improving alignment of patients' preferences with the treatments they
actually receive. The survey included eight questions about values modified from Kuppermann
et al.[3] Screening uptake and genetic counseling were abstracted from the chart review to
examine whether participants pursued prenatal screening after completing the study
and to control for participants who may have pursued prenatal screening or seen a
genetic counselor prior to completion of this study (after the first prenatal visit
and before the second prenatal visit). Surveys also included questions about the game
in regard to neutrality of information, satisfaction with the prenatal screening education
process, and satisfaction with the gaming experience. Finally, data analytics on game
usage were also collected.
General linear modeling with SPSS Version 24 (corrected for inequality of variance
where warranted) and chi-square testing was used to assess group differences in knowledge,
values, and screening/genetic counseling behavior. Spearman's rank correlation coefficient
was used to assess the relationship between game usage (time and click data) and the
outcome variables. The study was powered a priori (0.80), α = 0.05, to detect a medium/large effect size (Cohen's d = 0.67) for the primary outcome of knowledge, assuming an 80% correct knowledge response,
a standard deviation of 3% with equal groups of 36 participants.
Results
Seventy-nine participants were randomized to the two groups: 39 in the control group
and 40 in the intervention group. There was a technical fault with the data analytics
function for the Meaning of Screening game for the first three participants in the
intervention group, and these participants were dropped from the analysis. Three participants
exited the game within 20 seconds of beginning the game and were dropped from the
analysis making our total sample (N = 73; 39 in the control group and 34 in the intervention group) (see CONSORT [CONsolidated
Standards Of Reporting Trials] diagram in [Fig. 3]).
Fig. 3 CONSORT flow diagram. OB, obstetric.
The groups were equivalent on demographic variables ([Table 1]). The average age of our participants was 29.82 (4.96) years old, 80% were White
and 84% were Non-Hispanic, 66% had graduated college or more formal education, and
43% had an income between $50,001 and $150,000.
Table 1
Demographics
|
Characteristics
|
Standard of care
|
Meaning of screening
|
Total
|
|
n = 39
|
n = 34
|
n = 73
|
|
Age at enrollment (years)
|
29.56 (5.20)
|
30.13 (4.72)
|
29.82 (4.96)
|
|
Race
|
|
White
|
33 (84.6%)
|
25 (73.5%)
|
58 (79.5%)
|
|
Non-White
|
6 (15.4%)
|
9 (26.5%)
|
15 (20.5%)
|
|
Ethnicity
|
|
Hispanic
|
4 (10.3%)
|
7 (22.6%)
|
11 (15.7%)
|
|
Non-Hispanic
|
35 (89.7%)
|
24 (77.4%)
|
59 (84.3%)
|
|
Income
|
|
Under US$24,999
|
4 (10.5%)
|
1 (3.1%)
|
5 (7.1%)
|
|
US$25,000–US$50,000
|
7 (18.4%)
|
5 (15.6%)
|
12 (17.1%)
|
|
US$50,001–US$100,000
|
14 (36.8%)
|
16 (50%)
|
30 (42.9%)
|
|
US$100,001–US$150,000
|
8 (21.1%)
|
5 (15.6%)
|
13 (18.6%)
|
|
Over US$150,000
|
2 (5.3%)
|
2 (6.3%)
|
4 (5.7%)
|
|
Not sure/did not answer
|
3 (7.9%)
|
3 (9.4%)
|
6 (8.6%)
|
|
Education
|
|
Less than college graduate
|
12 (30.8%)
|
12 (37.5%)
|
24 (33.8%)
|
|
College graduate and above
|
27 (69.2%)
|
20 (62.5%)
|
47 (66.2%)
|
As hypothesized, participants randomized to the intervention group had significantly
higher knowledge scores (m = 21.41; standard deviation [SD] = 1.74) than participants in the control group (m = 19.59; SD = 3.31), p = 0.004 (see [Table 2] for the results).
Table 2
Knowledge, values, and screening behavior
|
Outcome
|
Standard of care, n = 39
|
Meaning of screening, n = 34
|
p-Value
|
|
Knowledge
|
|
Knowledge total score[a]
|
19.59 (3.31)
|
21.41 (1.74)
|
0.004
|
|
Values
|
|
Which would be harder for you: having a child with Down's syndrome or having a miscarriage
that may be caused by a prenatal test?[b]
|
3.85 (1.23)
|
3.24 (1.33)
|
0.045
|
|
If you were told that your fetus had Down's syndrome, would you choose to have an
abortion?[c]
|
1.44 (0.94)
|
1.97 (1.22)
|
0.051
|
|
Screening behavior
|
|
Received screening after study
|
6 (15%)
|
11 (32%)
|
0.087
|
a Number correct of 23 knowledge items.
b Single-item 1 to 5 scale (1, definitely worse to have a child with Down's syndrome;
5, definitely worse to have a miscarriage).
c Single-item 1 to 5 scale (1, no, I definitely would not have an abortion; 5, yes, I definitely would have an abortion).
Value clarification questions were also asked to control for beliefs regarding Down's
syndrome and risks associated with diagnostic testing. For example, if participants
self-reported values that indicated that they were more likely to risk a miscarriage
from invasive screening tests than have a child with Down's syndrome, then these individuals
were coded as “more likely to engage in prenatal screening.” Participants in the two
groups only significantly differed on two value questions. When asked, “Which would
be harder for you, having a child with Down's syndrome or having a miscarriage that
may be caused by a prenatal test?” participants playing the game reported higher scores
toward harder having a child with Down's syndrome (m = 3.85; SD = 1.23) than those participants in the control group (m = 3.24; SD = 1.28), p = 0.045. The other question was “If you were told that your fetus had Down's syndrome,
would you choose to have an abortion?” and participants playing the game reported
higher scores toward termination (m = 1.97; SD = 1.22) than those in the control group (m = 1.44; SD = 0.94), p = 0.051. These variables were added as covariates to the analysis and did not significantly
influence prenatal screening uptake between the two groups. All the other value questions
were statistically equivalent between the groups.
To assess the efficacy of the game and to evaluate whether it influenced participants
to take a particular screening decision, screening uptake and genetic counseling were
obtained from the chart review. The groups were similar in frequency of having screening
after the study (control = 6 [15%] vs. intervention = 11 [32%]; p = 0.087).
The median time of game playing was 6:43 (range: 2:17–16:44) and the median number
of clicks on items within the game was 49 (range: 14–242). Time spent playing the
game was not correlated with any of the outcomes. The number of clicks was correlated
with the behavior of having screening performed after the study (rs
= 0.36; p = 0.037). For participants in the control group, official time for reviewing the
brochure was approximately 1 to 2 minutes as reported by research coordinators. Satisfaction
results with the game decision aid are presented in [Table 3].
Table 3
Satisfaction with the game decision tool
|
Questions about the game experience (n = 34)
|
Percentage
|
|
How would you rate the amount of information you just received about prenatal testing?
|
2.9%: a little more than I needed
97%: about right or more than I needed
2.9%: a lot less than I needed
|
|
How clearly was that information presented?
|
50%: everything was clear
47.1%: most things were clear
2.9%: many things were unclear
|
|
How balanced (both the pros and cons) was the information in the game?
|
17.6%: clearly slanted toward screening
32.4%: slightly slanted toward screening
50%: completely balanced
|
|
Were there any tests or procedures that you were hoping to learn about but were unable
to find in the program?
|
94.1%: reported “no”
5.9%: reported “yes”
|
|
Were there any testing strategies that you were interested in that were not discussed
by the game?
|
97.1%: reported “no”
2.9%: reported “yes”
|
|
I would recommend this game to a friend who is pregnant.
|
88.3%: agree or strongly agree
11.7%: probably not or no
|
|
I have a positive opinion toward video games.
|
42%: agree or strongly agree
38.7%: neither agree nor disagree
19.4%: disagree
|
|
Playing this game was a new kind of experience for me.
|
67.7%: agree
19.4%: neither agree nor disagree
12.9%: disagree or strongly disagree
|
|
I found the experience worthwhile.
|
73.5%: agree or strongly agree
12.9%: neither agree nor disagree
6.4%: disagree or strongly disagree
|
Discussion
Gaming is a pervasive aspect of American culture. About 60% of all Americans play
computer or video games during their leisure time, and in most of those cases, they
play for at least 3 hours per week.[15] The average age of a player in the United States is 35 years old, and 41% of game
players are women. In fact, women aged 18 or older represent a significantly greater
portion of the game-playing population than boys aged 18 or younger.[15] The widespread appeal of games among adults creates a unique opportunity for education
within health care, allowing patients to actively engage with information, or play
with it, as opposed to absorbing it in a didactic fashion.
This study developed and evaluated the efficacy of a game-based decision aid for prenatal
screening among a general population of pregnant women compared with usual care (brochure-based
decision aid). The results demonstrated high satisfaction and more time interacting
with the information about prenatal screening in a game format that resulted in significantly
higher knowledge outcomes. Furthermore, there were no differences between the two
groups in prenatal screening uptake after the study. In general, the use of a game
decision aid in this study suggests a new approach to promoting informed decision-making
among pregnant women.
Despite improved knowledge outcomes and high satisfaction with this type of decision
aid, more in-depth research is needed to assess how the features of games specifically
address the components of a decision aid, such as values clarification, decisional
conflict, and shared decision-making with providers. Both values clarification and
shared decision-making with providers are extremely important in this domain of prenatal
care partly due to the voluntary nature of this type of screening test. Research has
shown that information about prenatal screening is often offered to patients based
on the perceptions by their prenatal care providers, including perceptions about risk
and about whether a couple is likely to want or use the screening results.[16]
[17] Regardless of the prenatal screening decision made by the couple or pregnant woman,
clearly the decisions are heavily influenced by how, if at all, the provider communicates
the screening options and information.[17]
[18] More research is needed to assess how a game that allows exploration of different
choices impacts shared decision-making with providers.
In addition, different choices and the potential outcomes of these choices as they
relate to personal values and pregnancy outcomes could also be explored, which, in
turn, may assist in more informed decision-making. Values are principles or standards
of behavior an individual deems highly important in life. As discussed previously,
values clarification is a critical component in decision aids, and games may be an
ideal modality to explore different outcomes of prenatal screening from varying types
of results. Thus, pregnancy outcomes of a diagnosis of a fetus with Down's syndrome
or termination could be explored in a game setting that is private and allows more
personal reflection prior to decision-making about prenatal screening. Future addition
to the decision aid game could add these potential outcomes.
In addition, there were some interesting results relating to the appropriate use of
a game format for a decision aid on health care decisions. Those who “clicked” more
on the avatars to learn facts, and ask and answer questions between the avatars also
had a higher uptake of prenatal screening. This could have been a spurious finding
because time playing the game was not associated with prenatal screening uptake. However,
it is interesting that increased interactivity with the game, self-driven by the woman,
is associated with higher screening uptake but not with differences in knowledge.
One possibility is that the process of seeing avatars, which reflect a diverse group
of pregnant women discuss facts and questions about prenatal screening, may result
in a more positive perspective toward screening. Alternatively, women who were predisposed
to pursue testing may have spent more time with the game to better understand prenatal
screening. Furthermore, the visual layout of the game was also positive in bright
colors and a pleasant outdoor environment. However, this also made the game more attractive
and resulted in more time spent with the game than the brochure.
Thus, the features that make games interesting may also promote a more positive attitude
toward prenatal screening as opposed to not screening. It is important to maintain
a nondirective nature in education for prenatal screening, and that may pose significant
challenges for the game context. Games often are engaging through the provision of
rewards to the gamer for success in working through barriers and problems toward an
ultimate goal. In the health care domain, games can use such reward strategies to
promote knowledge and adherence to professional recommendations. In our context, our
goal is to neither promote nor inhibit prenatal screening per se but to promote informed
decision-making, values clarification, and communication between partners driven by
theory through serious game design. More research is needed to identify how these
game features such as color scheme, game environment, and interactions and physical
representation of avatars influence decision-making.
This study used a randomized design with a focus on screening choices including some
information about diagnostic outcomes. However, it only included outcome data on cell-free
DNA (cfDNA) and did not include outcome data that compared and contrasted cfDNA with
other prenatal screening options. The research team purposefully limited the game
to cfDNA at this stage of the research because implications for counseling and informed
decision-making of pregnant women are similar for other prenatal screening tests.
Despite cfDNA having better detection rate among older women,[19] the general approach to education about prenatal screening across the different
options is the same. Most OB clinics provide brochures at the first prenatal visit,[20] and some may or may not discuss the options with their obstetrician and/or a genetic
counselor. cfDNA was chosen because it has a better overall detection rate, and the
purpose of the game was not to educate about each type of prenatal screening option
and how each type of screening is conducted but if prenatal screening was an appropriate
choice in general.
In addition, this study was only able to include a small sample of women with limited
diversity from an OB clinic of an academic urban medical center. Next steps for the
game design will need to include value preferences of the patient into the game as
opposed to computerized survey questions to increase personalization prior to decision-making.
Knowledge was only assessed after the intervention so that we are unable to explore knowledge gains over time. Finally,
it is important that any future research assesses the neutrality of a gaming decision
aid on outcomes. Any decision support tool should not encourage or discourage a particular
choice and additional research on how entertainment or pleasant visual features may
impact decisions without bias as well as how it impacts shared decision-making with
providers is needed. Future research will explore the impact of this game with a more
diverse sample, both nationally and in terms of racial/ethnic makeup.
Conclusion
Outcomes of this research show promise for the use of games to educate about prenatal
screening as well as other genetic testing decisions. The game environment appeared
to motivate participants to interact more with the information, resulting in higher
knowledge. More research is needed to understand how the features of a game influence
motivation to continue to play and impact patient decision-making and decisional outcomes.
