Clinical trial NCT03374891: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Official title: DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Heart Failure
Keywords: Shared Decision Making;
Defibrillator
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-12-15
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Knowledge About Defibrillation at Baseline
timeFrame: Baseline
measure: Knowledge About Defibrillation at 1 Month
timeFrame: 1 month
measure: Knowledge About Defibrillation at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Reach of Eligible Patients
timeFrame: Baseline
Other outcomes:
measure: Differential Effect by Age
timeFrame: Baseline, 1 month, 6 months
measure: Differential Effect by Heart Failure Type
timeFrame: Baseline, 1 month, 6 months
measure: Differential Effect by Type of Device
timeFrame: Baseline, 1 month, 6 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Daniel D Matlock, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knoepke CE, Wallace BC, Allen LA, Lewis CL, Gupta SK, Peterson PN, Kramer DB, Brancato SC, Varosy PD, Mandrola JM, Tzou WS, Matlock DD. Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009352. doi: 10.1161/CIRCOUTCOMES.122.009352. Epub 2022 Nov 15.