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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374891
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE May 28, 2018
Estimated Primary Completion Date May 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2019)
  • 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Official Title  ICMJE DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Heart Failure, Systolic
  • Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Educational video and/or handout
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 27, 2023
Estimated Primary Completion Date May 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bryan C Wallace, BS 303-724-7429 bryan.wallace@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374891
Other Study ID Numbers  ICMJE 17-1697
1R01HL136403-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Daniel D Matlock, MD, MPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP