Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04599166 |
| Other study ID # |
IR-16274 |
| Secondary ID |
R21NR019363 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2021 |
| Est. completion date |
December 7, 2022 |
Study information
| Verified date |
May 2024 |
| Source |
Milton S. Hershey Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators developed a "serious game" intervention called "Who Would You Choose:
Serious Fun" (WWYC) to help people consider the key qualities healthcare spokespersons should
have. The intervention uses a spinner, cards, and dice, along with a smart-phone App to
prompt players (using scenarios and metaphors) to choose a spokesperson whose qualities are
best suited to the role. Friendly competition is encouraged by having players receive points
for correct answers, and additional points for good explanations of their choices. At the end
of the game, players identify a real-life spokesperson based on the qualities considered
during game-play. Then, using an associated smart-phone App, the intervention will help spark
communication between the player and their chosen spokesperson.
Description:
Advance care planning (ACP) is the process of thinking through and articulating in advance
one's preferences for future medical care. It has long been promoted as a way for people to
receive medical treatment consistent with their values, goals, and preferences. While ACP
typically involves decision-making about specific life-sustaining treatments, choosing who
will make medical decisions when the patient cannot is considered by many to be the single
most important ACP action a person can take. When patients fail to designate a healthcare
spokesperson (henceforth spokesperson), it leads to uncertainty about who will make medical
decisions, what treatments are to be accepted or declined, and on what basis-which can lead
to familial conflict, unwanted and costly medical care, and avoidable patient suffering. So,
too, when patients choose the "wrong" person to represent them, the patient's wishes are less
likely to be known or respected. The investigation team's own research suggests that when
patients prefer fewer aggressive medical treatments, there is significantly lower concordance
between spokespersons' decisions and patients' wishes.
Patients, families, and ACP experts have identified several qualities as being especially
important for spokespersons to have. Ideally, spokespersons should know the patient's values,
be available when needed, be trustworthy and caring, have good judgment, and be able to stand
up under pressure. That said, many individuals (and state laws) assign spokespersons on the
basis of relationship (spouse, parent, etc.) rather than personal qualities. Surprisingly, no
interventions (to the team's knowledge) are explicitly designed to help people consider the
actual qualities of the person chosen as spokesperson, much less engage this individual to
confirm that this person can fully represent the patient's wishes should the need arise.
To address these gaps, the investigative team has developed a novel intervention that
includes a "serious game" to help people consider the qualities desired in a spokesperson,
then engage the person they choose for this role. Combining a serious topic with an enjoyable
activity ("gamification") has been effective at changing health-related behaviors in multiple
settings with the target population ("sandwich generation" and older adults). The game
element of the intervention, "Who Would You Choose: Serious Fun" (WWYC), prompts players
(using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to
the role. At the end of the game, players identify a real-life spokesperson based on the
qualities considered during gameplay. Then, using an online interface, WWYC will spark
communication between the player and their chosen spokesperson.
The long-term goal of this project is to help people make more thoughtful and informed
choices when selecting a spokesperson, and to help these spokespersons be better prepared for
the role of surrogate decision-maker. The current mixed methods study proposed here is
designed to learn whether and how WWYC helps individuals select an appropriate spokesperson
for healthcare decisions, as assessed via three specific aims:
Aim 1. To explore how playing the novel game Who Would You Choose affects people's choice of
a spokesperson. Using qualitative methods including focus groups and one-on-one interviews,
the investigative team will explore how WWYC affects individual players' thought process for
choosing a spokesperson, and whether the player's choice changes as a result of game-play.
Aim 2. To establish that WWYC is a feasible way to help individuals choose and engage a
spokesperson. The investigative team will judge it feasible if: 1) 100 individuals are
recruited to play the game; 2) >75% of game players report that playing the game is helpful
for choosing a spokesperson; 3) >75% of game players endorse the game; 4) >75% of
spokespersons engage with WWYC (using its online interface) following player request.
Aim 3. To integrate qualitative and quantitative data to explain how the experience of
playing the game relates to their spokesperson's willingness to engage. The investigative
team hypothesizes that a positive player experience with WWYC will be associated with
successful engagement with their spokesperson.
