Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves.
A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.
Studieoversikt
Detaljert beskrivelse
Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been shown to improve the quality of decisions and reduce burden on the decision maker in multiple clinical settings, yet almost none have focused on life-sustaining treatments in acute critical illness such as stroke. This study proposes a comprehensive frame shift in how the health care team and surrogates collaborate on decisions regarding life-sustaining treatments for acute illness, by developing a tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
The two project phases are: 1) Decision support intervention development; and 2) Pilot testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will be developed and incorporated into the tool.
The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient pairs in the intervention group, which equals a total of 100 subjects.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- The University of Michigan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Surrogates:
Inclusion Criteria:
- Self-identify as the surrogate decision maker for eligible patient
- Able to read and communicate in English without an interpreter
- Limited to one surrogate per patient
Exclusion Criteria:
- No prior relationship with patient
- Dementia or other cognitive or health condition that would impair their ability to participate
Patients:
Inclusion Criteria:
- Ischemic stroke or spontaneous intracerebral hemorrhage
- Impaired decisional capacity (per treating team)
- Enrolled on or before full hospital day 5
Minimum illness severity (either):
- National Institutes of Health Stroke Scale ≥ 10
- Glasgow coma scale ≤12
Exclusion Criteria:
- No surrogate available for study procedures
- Already on comfort measures only
- Physician refuses to allow approach for consent
- Pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Surrogate Arm
Usual care control group will complete baseline and follow-up questionnaires with standard decision making techniques.
This group will not be asked to use the decision making tool.
|
|
|
Eksperimentell: Surrogate Decision Tool Arm
This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.
|
A tailored web-based stroke decision support intervention.
This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability of the decision tool intervention
Tidsramme: Immediately post-intervention
|
The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale.
The Acceptability E-Scale is a 6-item scale.
A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation.
A score of 3 indicates a neutral evaluation.
An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher)
|
Immediately post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of the surrogate's prognostic estimate for functional recovery
Tidsramme: Within approximately 5 days of admission
|
Calculated as the absolute value of the difference between the surrogate's estimate of the probability (0-100%) of return to functional independence by 90 days and the model based estimate of modified Rankin of 0-2.
Range of this measure will be 0-100.
|
Within approximately 5 days of admission
|
|
Decisional Self Efficacy scale
Tidsramme: Within approximately 5 days of admission
|
11-item scale (a score of 0 indicates not at all confident and a 4 indicates very confident) with ordered categorical responses, converted to a 0-100 scale based on the average of the responses to each item.
A score of 0 means extremely low self-efficacy and a score of 100 means extremely high self-efficacy
|
Within approximately 5 days of admission
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Darin Zahuranec, University of Michigan
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUM00118298
- 1R21NR016332-01A1 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .
Kliniske studier på Decision tool
-
Jonsson Comprehensive Cancer CenterPatient-Centered Outcomes Research Institute; University of California,... og andre samarbeidspartnereRekrutteringScreening for brystkreft | Kunstig intelligens (AI)Forente stater
-
VA Office of Research and DevelopmentVanderbilt University Medical Center; VA Tennessee Valley Health Care SystemHar ikke rekruttert ennåAkutt nyreskade (AKI)Forente stater
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR)Fullført
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Påmelding etter invitasjonPrediabetes | Livsstil, sunn | Aktivering, pasientForente stater
-
NYU Langone HealthRekruttering
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD); Florida...FullførtSeksuelt overførbare sykdommer | Humant immunsviktvirus | Overføring av humant immunsviktvirusForente stater
-
Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine,...Avsluttet
-
University of California, San FranciscoFullførtHypertensjon | Nyresvikt, kroniskForente stater
-
Thomas Jefferson UniversityFullførtHematopoetisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForente stater
-
University of WashingtonRekruttering