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

DECIDE - ICD: 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Failure, Systolic
• Intervention / Treatment: Other: Educational video and/or handout

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 790
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Participants will fill out surveys; These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of Eligible Patients	Measuring how many patients of the eligible patient base are able to view or read the educational materials.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Daniel D Matlock, MD, MPH, University of Colorado, Denver

Publications and helpful links

General Publications

• Knoepke CE, Wallace BC, Allen LA, Lewis CL, Gupta SK, Peterson PN, Kramer DB, Brancato SC, Varosy PD, Mandrola JM, Tzou WS, Matlock DD. Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009352. doi: 10.1161/CIRCOUTCOMES.122.009352. Epub 2022 Nov 15.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Defibrillator; Shared Decision Making
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: 17-1697; 1R01HL136403-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No