A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
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ClinicalTrials.gov Identifier: NCT03374891 |
Recruitment Status :
Completed
First Posted : December 15, 2017
Results First Posted : July 8, 2022
Last Update Posted : July 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure, Systolic Heart Failure | Other: Educational video and/or handout | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 790 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators |
Actual Study Start Date : | May 28, 2018 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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)
- 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)
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374891
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Daniel D Matlock, MD, MPH | University of Colorado, Denver |
Documents provided by University of Colorado, Denver:
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT03374891 |
Other Study ID Numbers: |
17-1697 1R01HL136403-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 15, 2017 Key Record Dates |
Results First Posted: | July 8, 2022 |
Last Update Posted: | July 8, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Shared Decision Making; Defibrillator |
Heart Failure Heart Failure, Systolic Heart Diseases Cardiovascular Diseases |