- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03374891
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.
The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.
- Hypothesis 1a: PtDAs will reach over 50% of eligible patients.
- Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice.
- Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker.
The investigators propose 3 a priori hypotheses:
- The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old);
- The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic);
- The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Denver
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years or older
- English-speaking (videos and surveys have only been validated in English)
- Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation
Exclusion Criteria:
- Prisoners
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Participants will fill out surveys
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
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|
Aktiv komparator: Educational video and/or handout
These participants will receive an educational video and/or handout about the defibrillator process.
Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Knowledge About Defibrillation at Baseline
Tidsramme: Baseline
|
Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
|
Baseline
|
Knowledge About Defibrillation at 1 Month
Tidsramme: 1 month
|
Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
|
1 month
|
Knowledge About Defibrillation at 6 Months
Tidsramme: 6 months
|
Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Reach of Eligible Patients
Tidsramme: Baseline
|
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
|
Baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Differential Effect by Age
Tidsramme: Baseline, 1 month, 6 months
|
The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
|
Baseline, 1 month, 6 months
|
Differential Effect by Heart Failure Type
Tidsramme: Baseline, 1 month, 6 months
|
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
|
Baseline, 1 month, 6 months
|
Differential Effect by Type of Device
Tidsramme: Baseline, 1 month, 6 months
|
The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
|
Baseline, 1 month, 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Daniel D Matlock, MD, MPH, University of Colorado, Denver
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-1697
- 1R01HL136403-01 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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