Skip to main content
OpenTrials
Completed

NCT Number: NCT03374891

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational video and/or handout

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.

Primary outcomes

  1. Knowledge About Defibrillation at Baseline

    Time frame: 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.

  2. Knowledge About Defibrillation at 1 Month

    Time frame: 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.

  3. Knowledge About Defibrillation at 6 Months

    Time frame: 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.

Secondary outcomes

  1. Reach of Eligible Patients

    Time frame: Baseline

    Measuring how many patients of the eligible patient base are able to view or read the educational materials.

Other outcomes

  1. Differential Effect by Age

    Time frame: 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)

  2. Differential Effect by Heart Failure Type

    Time frame: 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)

  3. Differential Effect by Type of Device

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2017
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.