N/A
N=790
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Heart Failure, Systolic · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03374891 ↗Enrolled (actual)
790
Serious AEs
—
Results posted
Jul 2022
Primary outcome: Primary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational video and/or handout (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge About Defibrillation at Baseline |
53.4; 55.4 | — |
| PRIMARY Knowledge About Defibrillation at 1 Month |
57.1; 58.0 | — |
| PRIMARY Knowledge About Defibrillation at 6 Months |
56.6; 58.6 | — |
| SECONDARY Reach of Eligible Patients |
349; 88 | — |
Summary
The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03374891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.