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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374891
• Other study ID #: 17-1697
• Secondary ID: 1R01HL136403-01
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differential Effect by Age	The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)	Baseline, 1 month, 6 months
Other	Differential Effect by Heart Failure Type	The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)	Baseline, 1 month, 6 months
Other	Differential Effect by Type of Device	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).	Baseline, 1 month, 6 months
Primary	Knowledge About Defibrillation at 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.	Baseline
Primary	Knowledge About Defibrillation at 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.	1 month
Primary	Knowledge About Defibrillation at 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.	6 months
Secondary	Reach of Eligible Patients	Measuring how many patients of the eligible patient base are able to view or read the educational materials.	Baseline