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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL136403-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
The investigators propose 3 a priori hypotheses:
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants will fill out surveys | No Intervention | These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process. | |
| Educational video and/or handout | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video and/or handout | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 1 month |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reach of Eligible Patients | Measuring how many patients of the eligible patient base are able to view or read the educational materials. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 1 month, 6 months |
| Differential Effect by Heart Failure Type |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel D Matlock, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36378770 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surveys Only | These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were only collected for participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Surveys Only | These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process. |
| BG001 | Educational Video and/or Handout + Surveys |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was not able to be collected for all participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
6 Months
Serious Adverse Events and All cause Mortality were not collected for this study for any participant, due to the design of this implementation study. The only participants that were at risk for the incomplete consent process adverse event were the participants enrolled at the one site which required a separate written HIPAA authorization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surveys Only | These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incomplete consent process | Investigations | Non-systematic Assessment | Participants consented verbally, which was not an complete consent process due to HIPAA written consent requirements. HIPAA waiver later obtained. Only participants enrolled at 1 site with separate written HIPAA authorization were at risk. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Matlock, MD | University of Colorado Denver | Anschutz | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2018 | Jun 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2018 | Jun 14, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
| Baseline, 1 month, 6 months |
| 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). | Baseline, 1 month, 6 months |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| 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. | Data was not able to be collected for all participants. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| 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. | Data was not able to be collected for all participants. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Reach of Eligible Patients | Measuring how many patients of the eligible patient base are able to view or read the educational materials. | The control group did not receive the intervention, and was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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) | Not Posted | Baseline, 1 month, 6 months | Participants |
| 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) | Not Posted | Baseline, 1 month, 6 months | Participants |
| 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). | Not Posted | Baseline, 1 month, 6 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 3 |
| 346 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 444 |
|
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