Heart Failure, Heart Failure, Systolic
Conditions
Keywords
Shared Decision Making;, Defibrillator
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.
Interventions
OTHEREducational 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.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge About Defibrillation at Baseline | 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. |
| Knowledge About Defibrillation at 6 Months | 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. |
| Knowledge About Defibrillation at 1 Month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach of Eligible Patients | Baseline | Measuring how many patients of the eligible patient base are able to view or read the educational materials. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Differential Effect by Age | 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 Type of Device | 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). |
| Differential Effect by Heart Failure Type | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surveys Only These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process. | 323 |
| Educational Video and/or Handout + Surveys 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.
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. | 437 |
| Total | 760 |
Baseline characteristics
| Characteristic | Surveys Only | Total | Educational Video and/or Handout + Surveys |
|---|---|---|---|
| Age, Continuous | 66 years | 66.5 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 42 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 299 Participants | 718 Participants | 419 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 84 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 26 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 44 Participants | 28 Participants |
| Race (NIH/OMB) White | 250 Participants | 589 Participants | 339 Participants |
| Region of Enrollment United States | 323 participants | 760 participants | 437 participants |
| Sex: Female, Male Female | 89 Participants | 209 Participants | 120 Participants |
| Sex: Female, Male Male | 234 Participants | 551 Participants | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 3 / 346 | 0 / 444 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Knowledge About Defibrillation at 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.
Time frame: 1 month
Population: Data was not able to be collected for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveys Only | Knowledge About Defibrillation at 1 Month | 57.1 score on a scale | Standard Deviation 18.2 |
| Educational Video and/or Handout + Surveys | Knowledge About Defibrillation at 1 Month | 58.0 score on a scale | Standard Deviation 15.4 |
Primary
Knowledge About Defibrillation at 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.
Time frame: 6 months
Population: Data was not able to be collected for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveys Only | Knowledge About Defibrillation at 6 Months | 56.6 score on a scale | Standard Deviation 17.4 |
| Educational Video and/or Handout + Surveys | Knowledge About Defibrillation at 6 Months | 58.6 score on a scale | Standard Deviation 14.5 |
Primary
Knowledge About Defibrillation at 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.
Time frame: Baseline
Population: Data was not able to be collected for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveys Only | Knowledge About Defibrillation at Baseline | 53.4 score on a scale | Standard Deviation 17.6 |
| Educational Video and/or Handout + Surveys | Knowledge About Defibrillation at Baseline | 55.4 score on a scale | Standard Deviation 17 |
Secondary
Reach of Eligible Patients
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Time frame: Baseline
Population: The control group did not receive the intervention, and was not analyzed for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Educational Video and/or Handout + Surveys | Reach of Eligible Patients | Were administered intervention by hospital | 349 Participants |
| Educational Video and/or Handout + Surveys | Reach of Eligible Patients | Were not administered intervention by hospital | 88 Participants |
Other Pre-specified
Differential Effect by Age
The decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old)
Time frame: Baseline, 1 month, 6 months
Other Pre-specified
Differential Effect by Heart Failure Type
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Time frame: Baseline, 1 month, 6 months
Other Pre-specified
Differential Effect by Type of Device
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).
Time frame: Baseline, 1 month, 6 months