Advance Care PlanningNCT04557930
EFFICACY: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists
A study testing Hopewell Hospitalist Video Game in people with Advance Care Planning, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Hopewell Hospitalist is a theory-based adventure video game designed to increase the likelihood that a physician will engage in an advance care planning (ACP) conversation with a patient over the age of 65. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Hopewell Hospitalist Video Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Hospital Inclusion Criteria:
- Value-based delivery model of care (Bundled Payment Care Initiative)
- Staffed by Sound Physicians for at least 2 quarters
- Advance care planning billing rate in prior quarter greater than 0 percent
- Employs a nurse liaison
- Hospitalist chief approval to approach hospitalists
Hospital Exclusion Criteria:
- Sound Physicians no longer staffing the hospital
- Not staffed by Sound Physicians for at least 2 quarters
- Advance care planning billing rate in prior quarter of 0 percent
- Does not employ a nurse liaison
- Hospitalist chief disapproval to approach hospitalists
- Hospitalist chief does not provide contact information for hospitalists
- Target number of hospitalists for the "step" has been met or exceeded
Hospitalist Inclusion Criteria:
- Employed by Sound for at least 2 quarters and staffing an eligible hospital for at least 1 quarter
- ACP billing rate in prior quarter greater than 0 percent or answers eligibility question affirming use of ACP billing codes
- Provides informed consent
- Name matches a name in the contact list for the sample; OR is verified by communication through an employer-based email address
- Receipt of a functional iPad within study step time frame
Hospitalist Exclusion Criteria:
- Not employed by Sound for at least 2 quarters and staffing an eligible hospital for at least 1 quarter
- ACP billing rate in prior quarter of 0 percent or answers eligibility question refusing use of ACP billing
- Does not provide informed consent
- Provides consent after the given deadline for consenting
- Name does not match a name in the contact list for the sample; OR cannot be verified by communication through an employer-based email address
- Receipt of a nonfunctional iPad within study step time frame
- If the number of participants who consent per site exceeds targets, then participants who are part-time employees will be preferentially excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning Conversations by Hospitalists With Older Adults
Hopewell Hospitalist is a theory-based adventure video game designed to increase the likelihood that a physician will engage in an advance care planning (ACP) conversation with a patient over the age of 65. Drawing on the theory of narrative engagement, players assume the persona of a hospitalist and navigate a series of clinical encounters with seriously-ill patients over the age of 65. Players experience the consequences of having (or not having) ACP conversations in a timely fashion. The planned study is a pragmatic stepped-wedge crossover phase III trial testing the efficacy of Hopewell Hospitalist for increasing ACP rates measured by ACP billing frequency.
Read the detailed description
Introduction: Fewer than half of all people in the U.S. have a documented advance care plan, such as an advance directive, despite their importance in ensuring high-quality care at the end-of-life. Hospitalization offers an opportunity for physicians to initiate advance care planning (ACP) conversations. Despite expert recommendations, hospital-based physicians (hospitalists) do not routinely engage in these conversations, reserving them for the critically ill.
The objective of this study is to test the effect of a novel behavioral intervention on the incidence of ACP conversations by hospitalists practicing at a stratified random sample of hospitals drawn from 220 US acute care hospitals staffed by a large, nationwide acute care physician practice with an ongoing ACP quality improvement initiative.
Methods and analysis: We developed Hopewell Hospitalist, a theory-based adventure video game, to modify physicians' attitudes towards ACP conversations, and to increase their motivation for engaging in them. Drawing on the theory of narrative engagement, players assume the persona of Andy Jordan, a hospitalist who accepts a new job in a small town. Through a series of clinical encounters with seriously-ill patients over the age of 65, players experience the consequences of having (or not having) ACP conversations in a timely fashion. The planned study is a pragmatic stepped-wedge crossover phase III trial, testing the efficacy of Hopewell Hospitalist for increasing ACP conversations. We will randomize 40 hospitals to the month (step) in which they receive the intervention. We aim to recruit 30 hospitalists from up to 8 hospitals each step to complete the intervention, playing Hopewell Hospitalist for at least 2 hours on an iPad pre-loaded with the game. The primary outcome is ACP billing for patients age 65 and older managed by participating hospitalists. We hypothesize that the intervention will increase ACP billing in the quarter after dissemination, and have 80% power to detect a 1% absolute increase and 99% power to detect a 3.5% absolute increase.
Ethics and dissemination: Dartmouth's Committee for the Protection of Human Subjects has approved the study protocol, which is registered on clinicaltrials.gov. We will disseminate the results through manuscripts and the trials website. Hopewell Hospitalist will be made available on the iOS Application Store for download, free of cost, at the conclusion of the trial.
- Conditions
- Advance Care Planning
- Being tested
- Hopewell Hospitalist Video Game
- Keywords
- advance care planning, physician performance, serious games, narrative engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hopewell Hospitalist Video GameBehavioural
Hopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control | No intervention | The control arm occurred prior to receipt of the video game intervention. Each hospital group 'crossed over' from control to intervention at a randomized time point based on their assignment to the 'step' of the trial. |
| Video Game Intervention | Experimental | Each hospital group 'crossed over' from control to intervention at a randomized time point. Physicians working at these hospitals, who agreed to participate in the trial, received a study iPad and were asked to play the video game loaded on the iPad for a minimum of 2 hours. Receives: Behavioral: Hopewell Hospitalist Video Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Advance Care Planning Bills
Percentage of advance care planning bills submitted by physicians in the trial for patients over the age of 65 in the period before and after the roll-out of the video game intervention at their hospital. Advance care planning bills are defined as the presence/absence of ACP charges (Medicare billing codes 99497 or 99498) during a patient's hospitalization.
Measured: 11 months
Secondary outcomes (5)
Percentage of Patients Who Died While in Hospital
Number of patients who died in the pre-intervention and post-intervention period/total number of patients for both periods
Measured: 11 months
Percentage of Patients Readmitted in 7 Days
Number of patients readmitted within 7 days/Total number of patients treated in the pre-intervention and post-intervention periods
Measured: 11 months
Percentage of Patients Readmitted Within 30-days
Number of patients readmitted within 30-days/Total number of patients in the pre-intervention and post-intervention periods
Measured: 11 months
Percentage of Patients Who Received Critical Care
Number of patients who received critical care while admitted/total number of patients admitted in the pre-intervention and post-intervention periods
Measured: 11 months
Length of Stay
Duration of hospitalization for patients treated in the pre-intervention and post-intervention periods
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jul 2020
- Primary completion31 May 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped wedge crossover trial randomizing physician participants at the group level (i.e., hospital). Each hospital group 'crossed over' from control to intervention at a randomized time point.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sound Physicians, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amber Barnato, Dartmouth-Hitchcock Medical Center
- Investigators
- Amber Barnato, MD, MPH, MS, Principal investigator, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�Deepika Mohan, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557930
- Sponsor's protocol ID
- STUDY00031186
- Other IDs
- P01AG019783
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2020
- Last updated
- 10 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified participant data and supporting information with other researchers upon request to the PI.
Publications
Mohan D, MacMartin MA, Chelen JSC, Maezes CB, Barnato AE. Development of a theory-based video-game intervention to increase advance care planning conversations by healthcare providers. Implement Sci Commun. 2021 Oct 13;2(1):117. doi: 10.1186/s43058-021-00216-8.
PubMed 34645515Mohan D, O'Malley AJ, Chelen J, MacMartin M, Murphy M, Rudolph M, Barnato A. Videogame intervention to increase advance care planning conversations by hospitalists with older adults: study protocol for a stepped-wedge clinical trial. BMJ Open. 2021 Mar 22;11(3):e045084. doi: 10.1136/bmjopen-2020-045084.
PubMed 33753443Mohan D, O'Malley AJ, Chelen J, MacMartin M, Murphy M, Rudolph M, Engel JA, Barnato AE. Using a Video Game Intervention to Increase Hospitalists' Advance Care Planning Conversations with Older Adults: a Stepped Wedge Randomized Clinical Trial. J Gen Intern Med. 2023 Nov;38(14):3224-3234. doi: 10.1007/s11606-023-08297-y. Epub 2023 Jul 10.
PubMed 37429972
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning Conversations by Hospitalists With Older Adults
- ClinicalTrials.gov ID
- NCT04557930
- Acronym / sponsor ID
- STUDY00031186
- Conditions
- Advance Care Planning
- Keywords
- advance care planning, physician performance, serious games, narrative engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Sound Physicians, National Institute on Aging (NIA)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hopewell Hospitalist is a theory-based adventure video game designed to increase the likelihood that a physician will engage in an advance care planning (ACP) conversation with a patient over the age of 65. Drawing on the theory of narrative engagement, players assume the persona of a hospitalist and navigate a series of clinical encounters with seriously-ill patients over the age of 65. Players experience the consequences of having (or not having) ACP conversations in a timely fashion. The planned study is a pragmatic stepped-wedge crossover phase III trial testing the efficacy of Hopewell Hospitalist for increasing ACP rates measured by ACP billing frequency.
Detailed description
Introduction: Fewer than half of all people in the U.S. have a documented advance care plan, such as an advance directive, despite their importance in ensuring high-quality care at the end-of-life. Hospitalization offers an opportunity for physicians to initiate advance care planning (ACP) conversations. Despite expert recommendations, hospital-based physicians (hospitalists) do not routinely engage in these conversations, reserving them for the critically ill.
The objective of this study is to test the effect of a novel behavioral intervention on the incidence of ACP conversations by hospitalists practicing at a stratified random sample of hospitals drawn from 220 US acute care hospitals staffed by a large, nationwide acute care physician practice with an ongoing ACP quality improvement initiative.
Methods and analysis: We developed Hopewell Hospitalist, a theory-based adventure video game, to modify physicians' attitudes towards ACP conversations, and to increase their motivation for engaging in them. Drawing on the theory of narrative engagement, players assume the persona of Andy Jordan, a hospitalist who accepts a new job in a small town. Through a series of clinical encounters with seriously-ill patients over the age of 65, players experience the consequences of having (or not having) ACP conversations in a timely fashion. The planned study is a pragmatic stepped-wedge crossover phase III trial, testing the efficacy of Hopewell Hospitalist for increasing ACP conversations. We will randomize 40 hospitals to the month (step) in which they receive the intervention. We aim to recruit 30 hospitalists from up to 8 hospitals each step to complete the intervention, playing Hopewell Hospitalist for at least 2 hours on an iPad pre-loaded with the game. The primary outcome is ACP billing for patients age 65 and older managed by participating hospitalists. We hypothesize that the intervention will increase ACP billing in the quarter after dissemination, and have 80% power to detect a 1% absolute increase and 99% power to detect a 3.5% absolute increase.
Ethics and dissemination: Dartmouth's Committee for the Protection of Human Subjects has approved the study protocol, which is registered on clinicaltrials.gov. We will disseminate the results through manuscripts and the trials website. Hopewell Hospitalist will be made available on the iOS Application Store for download, free of cost, at the conclusion of the trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A stepped wedge crossover trial randomizing physician participants at the group level (i.e., hospital). Each hospital group 'crossed over' from control to intervention at a randomized time point.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | No intervention | –The control arm occurred prior to receipt of the video game intervention. Each hospital group 'crossed over' from control to intervention at a randomized time point based on their assignment to the 'step' of the trial. |
| Video Game Intervention | Experimental | Behavioral: Hopewell Hospitalist Video GameEach hospital group 'crossed over' from control to intervention at a randomized time point. Physicians working at these hospitals, who agreed to participate in the trial, received a study iPad and were asked to play the video game loaded on the iPad for a minimum of 2 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hopewell Hospitalist Video GameHopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations. | Behavioural | Video Game Intervention |
Primary outcome
Percentage of Patients With Advance Care Planning Bills
Time frame: 11 months
Percentage of advance care planning bills submitted by physicians in the trial for patients over the age of 65 in the period before and after the roll-out of the video game intervention at their hospital. Advance care planning bills are defined as the presence/absence of ACP charges (Medicare billing codes 99497 or 99498) during a patient's hospitalization.
5 secondary outcomes
Percentage of Patients Who Died While in Hospital
Time frame: 11 months
Percentage of Patients Readmitted in 7 Days
Time frame: 11 months
Percentage of Patients Readmitted Within 30-days
Time frame: 11 months
Percentage of Patients Who Received Critical Care
Time frame: 11 months
Length of Stay
Time frame: 11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34645515Mohan D, MacMartin MA, Chelen JSC, Maezes CB, Barnato AE. Development of a theory-based video-game intervention to increase advance care planning conversations by healthcare providers. Implement Sci Commun. 2021 Oct 13;2(1):117. doi: 10.1186/s43058-021-00216-8.
- Background: PubMed 33753443Mohan D, O'Malley AJ, Chelen J, MacMartin M, Murphy M, Rudolph M, Barnato A. Videogame intervention to increase advance care planning conversations by hospitalists with older adults: study protocol for a stepped-wedge clinical trial. BMJ Open. 2021 Mar 22;11(3):e045084. doi: 10.1136/bmjopen-2020-045084.
- Derived from this study: PubMed 37429972Mohan D, O'Malley AJ, Chelen J, MacMartin M, Murphy M, Rudolph M, Engel JA, Barnato AE. Using a Video Game Intervention to Increase Hospitalists' Advance Care Planning Conversations with Older Adults: a Stepped Wedge Randomized Clinical Trial. J Gen Intern Med. 2023 Nov;38(14):3224-3234. doi: 10.1007/s11606-023-08297-y. Epub 2023 Jul 10.
- Individual participant dataSharing planned: Yes. We will share de-identified participant data and supporting information with other researchers upon request to the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Barnato, MD, MPH, MS principal investigator
Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�
Deepika Mohan, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hopewell Hospitalist Video Game in people with Advance Care Planning, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Advance Care Planning Bills (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557930, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.