A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Heart Failure, Systolic; Heart Failure

Treatments: Other: Educational video and/or handout

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03374891

1R01HL136403-01 (U.S. NIH Grant/Contract)

17-1697

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 790 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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790 participants in 2 patient groups

Participants will fill out surveys

No Intervention group

Description:

These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.

Educational video and/or handout

Active Comparator group

Description:

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.

Treatment:

Other: Educational video and/or handout