N/A
Completed N=790
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Heart Failure, Systolic · Heart Failure
Source: ClinicalTrials.gov NCT03374891 ↗
Enrolled (actual)
790
Serious AEs
—
Results posted
Jul 2022
Primary outcomePrimary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
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.
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 | — |
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. Informational only — not medical advice.