- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04881968
EFFECTIVENESS: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists
11 februari 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1261
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
New Hampshire
-
Lebanon, New Hampshire, Verenigde Staten, 03766
- Dartmouth Hitchcock Medical Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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.
|
|
|
Experimenteel: 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 is een op maat gemaakte, op theorie gebaseerde avonturenvideogame die verhalende betrokkenheid gebruikt om arts-spelers te informeren over geavanceerde zorgplanning om de kans dat artsen deelnemen aan en factureren voor ACP-gesprekken te vergroten.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of Billed Advance Care Planning
Tijdsspanne: 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.
|
6 months (3 months pre and 3 months post intervention)
|
|
Merit-based Incentive Payment System Advance Care Planning Quality Score
Tijdsspanne: 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.
|
6 months (3 months pre and 3 months post intervention)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hospitalist-Managed Patient In-Hospital Mortality Rate
Tijdsspanne: 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)
|
|
Hospitalist-Managed Patient 90-Day Mortality Rate
Tijdsspanne: 6 months (3 months pre and 3 months post intervention)
|
90-day mortality rate for patients managed by enrolled hospitalists.
|
6 months (3 months pre and 3 months post intervention)
|
|
Sum of Resources Utilized by Hospitalist-Managed Patients
Tijdsspanne: 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)
|
|
Incidence of Hospitalist-Managed Patient Admission to ICU
Tijdsspanne: 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)
|
|
Incidence of Hospitalist-Managed Patient Mechanical Ventilation
Tijdsspanne: 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)
|
|
Incidence of Hospitalist-Managed Patient Receipt of Life-Sustaining Treatment(s)
Tijdsspanne: 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)
|
|
Hospitalist-Managed Patient Length of Stay
Tijdsspanne: 6 months (3 months pre and 3 months post intervention)
|
Total days between admission and discharge for patients managed by enrolled hospitalists.
|
6 months (3 months pre and 3 months post intervention)
|
|
Hospitalist-Managed Patient Disposition Status Type
Tijdsspanne: 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.).
|
6 months (3 months pre and 3 months post intervention)
|
|
Hospitalist-Managed Patient 90-Day Episode-Based Spending
Tijdsspanne: 6 months (3 months pre and 3 months post intervention)
|
Amount of total Medicare payments between index admission and 90-days for patients managed by enrolled hospitalists.
|
6 months (3 months pre and 3 months post intervention)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hopewell Hospitalist - Apple App Store and Google Analytics
Tijdsspanne: 3 months
|
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.
|
3 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Amber Barnato, MD, MPH, MS, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine�
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 juli 2021
Primaire voltooiing (Werkelijk)
13 augustus 2021
Studie voltooiing (Werkelijk)
13 augustus 2021
Studieregistratiedata
Eerst ingediend
6 mei 2021
Eerst ingediend dat voldeed aan de QC-criteria
6 mei 2021
Eerst geplaatst (Werkelijk)
11 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 februari 2022
Laatste update ingediend die voldeed aan QC-criteria
11 februari 2022
Laatst geverifieerd
1 februari 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00031186 - B
- P01AG019783 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
We will share de-identified participant data and supporting information with other researchers upon request to the PI.
IPD-tijdsbestek voor delen
Upon publication of the planned manuscripts.
Data will be retained through February 2028.
IPD-toegangscriteria voor delen
Data will require completion of a data use agreement with Dartmouth.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .