Choosing an Effective Healthcare Spokesperson: An Interactive Intervention

February 5, 2024 updated by: Benjamin H. Levi, Milton S. Hershey Medical Center
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.

Study Overview

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

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin H Levi, MD PhD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Actual)

December 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

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)?

YES

IPD Plan Description

We will present our findings at conferences and in peer-reviewed publications.

IPD Sharing Time Frame

At close of study in 2022.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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