- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04881968
EFFECTIVENESS: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists
11. februar 2022 oppdatert 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1261
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03766
- Dartmouth Hitchcock Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: 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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Eksperimentell: 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.
|
Hopewell Hospitalist er et tilpasset teoribasert eventyrvideospill som bruker narrativt engasjement for å utdanne legespillere i planlegging av forhåndspleie for å øke legers sannsynlighet for å delta i og fakturere for ACP-samtaler.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Billed Advance Care Planning
Tidsramme: 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
Tidsramme: 6 months (3 months pre and 3 months post intervention)
|
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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospitalist-Managed Patient In-Hospital Mortality Rate
Tidsramme: 6 months (3 months pre and 3 months post intervention)
|
In-hospital mortality rate for patients managed by enrolled hospitalists.
|
6 months (3 months pre and 3 months post intervention)
|
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Hospitalist-Managed Patient 90-Day Mortality Rate
Tidsramme: 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
Tidsramme: 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.
|
6 months (3 months pre and 3 months post intervention)
|
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Incidence of Hospitalist-Managed Patient Admission to ICU
Tidsramme: 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).
|
6 months (3 months pre and 3 months post intervention)
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Incidence of Hospitalist-Managed Patient Mechanical Ventilation
Tidsramme: 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).
|
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)
Tidsramme: 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).
|
6 months (3 months pre and 3 months post intervention)
|
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Hospitalist-Managed Patient Length of Stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hopewell Hospitalist - Apple App Store and Google Analytics
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Amber Barnato, MD, MPH, MS, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2021
Primær fullføring (Faktiske)
13. august 2021
Studiet fullført (Faktiske)
13. august 2021
Datoer for studieregistrering
Først innsendt
6. mai 2021
Først innsendt som oppfylte QC-kriteriene
6. mai 2021
Først lagt ut (Faktiske)
11. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY00031186 - B
- P01AG019783 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
We will share de-identified participant data and supporting information with other researchers upon request to the PI.
IPD-delingstidsramme
Upon publication of the planned manuscripts.
Data will be retained through February 2028.
Tilgangskriterier for IPD-deling
Data will require completion of a data use agreement with Dartmouth.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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