- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04881968
EFFECTIVENESS: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists
11 februari 2022 uppdaterad av: Amber Barnato, Dartmouth-Hitchcock Medical Center
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 physician 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 crossover phase III trial testing the effectiveness of providing physicians with a link to a free version of Hopewell Hospitalist as a means for increasing ACP rates measured by ACP billing frequency.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1261
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03766
- Dartmouth Hitchcock Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Hospitalist Inclusion Criteria:
- Employed by Sound
- Not previously included in the Efficacy Trial Arm of the study.
Hospitalist Exclusion Criteria:
- Not employed by Sound
- Does not provide informed consent
- Previously included in the Efficacy Trial Arm of the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Control: Usual Care
The control arm occurs prior to receipt of the video game intervention and reflects usual care.
Each hospitalist 'crosses over' from control to intervention at a single time point.
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Experimentell: Video Game Intervention
Each hospitalist 'crosses over' from control to intervention at a single time point by receiving a link to the Hopewell Hospitalist game via email and logging in to play the video game.
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Hopewell Hospitalist är ett skräddarsytt teoribaserat äventyrsspel som använder narrativt engagemang för att utbilda läkare i vårdplanering för att öka läkarnas sannolikhet att delta i och fakturera för AVS-konversationer.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Billed Advance Care Planning
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Change in physician advance care planning billing for patients over the age of 65 in the three months before and after the roll-out of the video game intervention at their hospital.
Advance care planning billing is defined as the presence/absence of ACP charges (Medicare billing codes 99497 or 99498) during a physician's patient's hospitalization.
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6 months (3 months pre and 3 months post intervention)
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Merit-based Incentive Payment System Advance Care Planning Quality Score
Tidsram: 6 months (3 months pre and 3 months post intervention)
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Change in the Merit-based Incentive Payment System (MIPS) self-report measure of advance care planning by enrolled hospitalists (MiPS-ACP quality score).
The MiPS-ACP quality score is the percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan.
The quality score ranges from 0-100%, with higher scores indicating that a greater proportion of patients with an advance care plan documented in the medical record.
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6 months (3 months pre and 3 months post intervention)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hospitalist-Managed Patient In-Hospital Mortality Rate
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
In-hospital mortality rate for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient 90-Day Mortality Rate
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
90-day mortality rate for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Sum of Resources Utilized by Hospitalist-Managed Patients
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Combined sum of resources utilized by patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
It is a composite measure including: admission to ICU, receipt of life-sustaining treatment(s) including mechanical ventilation, placement of tracheostomy, insertion of gastric feeding tube, new onset dialysis.
This measure ranges from 0 to 5, where higher scores indicate greater utilization of resources during the index hospitalization.
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Admission to ICU
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Incidence of admission to ICU for patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Mechanical Ventilation
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Incidence of mechanical ventilation of patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Receipt of Life-Sustaining Treatment(s)
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Incidence of placement of tracheostomy, insertion of gastric feeding tube, new onset dialysis for patients managed by enrolled hospitalists during their index hospitalization (first hospitalization in the relevant period: control or intervention).
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient Length of Stay
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Total days between admission and discharge for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient Disposition Status Type
Tidsram: 6 months (3 months pre and 3 months post intervention)
|
Type of status upon discharge of patients managed by enrolled hospitalists (e.g., discharged to home, to skilled nursing, to hospice, deceased, etc.).
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6 months (3 months pre and 3 months post intervention)
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Hospitalist-Managed Patient 90-Day Episode-Based Spending
Tidsram: 6 months (3 months pre and 3 months post intervention)
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Amount of total Medicare payments between index admission and 90-days for patients managed by enrolled hospitalists.
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6 months (3 months pre and 3 months post intervention)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hopewell Hospitalist - Apple App Store and Google Analytics
Tidsram: 3 months
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Number of unique downloads for the HH game will be provided by the Apple App store.
Using Google Analytics we will be able to discern time spent playing the game for each individual hospitalist using their unique log-in passphrase.
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3 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Amber Barnato, MD, MPH, MS, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juli 2021
Primärt slutförande (Faktisk)
13 augusti 2021
Avslutad studie (Faktisk)
13 augusti 2021
Studieregistreringsdatum
Först inskickad
6 maj 2021
Först inskickad som uppfyllde QC-kriterierna
6 maj 2021
Första postat (Faktisk)
11 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STUDY00031186 - B
- P01AG019783 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
We will share de-identified participant data and supporting information with other researchers upon request to the PI.
Tidsram för IPD-delning
Upon publication of the planned manuscripts.
Data will be retained through February 2028.
Kriterier för IPD Sharing Access
Data will require completion of a data use agreement with Dartmouth.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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