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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374891
Recruitment Status : Completed
First Posted : December 15, 2017
Results First Posted : July 8, 2022
Last Update Posted : July 8, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Heart Failure Other: Educational video and/or handout Not Applicable

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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).


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Daniel D Matlock, MD, MPH University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] January 10, 2018
Informed Consent Form  [PDF] March 27, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Shared Decision Making;
Defibrillator
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases