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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

790 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure, Systolic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Step-wedge design. 6 groups will begin recruiting participants as control participants. Throughout the study, at 5 month intervals, 1 randomly selected site at a time will begin intervention.

Due to the impact of COVID-19 on sites and patient visits from March-April 2020, we moved back the implementation of intervention dates for the 5th site (UCH/DH) by 2 months and the 6th site (Beth Israel) by 1 month.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Participants will fill out surveys

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Educational video and/or handout

Intervention Type OTHER

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.

Interventions

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Educational video and/or handout

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.

Intervention Type OTHER

Eligibility Criteria

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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