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 : Not yet recruiting
First Posted : December 15, 2017
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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.|
|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|
|Estimated Study Start Date :||May 28, 2018|
|Estimated Primary Completion Date :||May 27, 2023|
|Estimated Study Completion Date :||May 27, 2023|
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.
- Change from Baseline knowledge about defibrillation at 1 month and 6 months [ Time Frame: Baseline, 1 month, 6 months ]Multiple survey responses by participants will indicate knowledge changes over time.
- Reach of eligible patients [ Time Frame: Baseline, 1 month, 6 months ]Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374891
|Contact: Bryan C Wallace, BSemail@example.com|
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Daniel D Matlock, MD, MPH||University of Colorado, Denver|