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 : Recruiting
First Posted : December 15, 2017
Last Update Posted : June 25, 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|
|Actual 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.
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
|Contact: Bryan C Wallace, BSfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Bryan C Wallace 303-724-7429 email@example.com|
|Principal Investigator:||Daniel D Matlock, MD, MPH||University of Colorado, Denver|