- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599166
Choosing an Effective Healthcare Spokesperson: An Interactive Intervention
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to read and write in English
- 18 years or older
- Have a working smart phone
Exclusion Criteria:
- NOT able to read and write in English
- Younger than 18 years old
- Does NOT have a working smart phone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participant arm
Participants will be recruited to complete the WWYC intervention.
|
"Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role.
At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Who Changed Their Choice of Spokesperson
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endorsement of the WWYC Intervention
Time Frame: 4 weeks
|
>75% of WWYC participants endorse WWYC, as measured by the Net Promoter Score
|
4 weeks
|
Participation Rate
Time Frame: Aug 2021 - Dec 2022
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Aug 2021 - Dec 2022
|
|
Spokesperson Response (Percentage)
Time Frame: 8 weeks
|
Percentage of spokespersons who responded to participant request following intervention
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endorsement of the WWYC Intervention
Time Frame: 4 weeks
|
>75% of WWYC participants endorse WWYC, as measured by the Net Promoter Score
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin H Levi, MD PhD, Milton S. Hershey Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IR-16274
- R21NR019363 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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