Trial Outcomes & Findings for A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators (NCT NCT03374891)
NCT ID: NCT03374891
Last Updated: 2022-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
790 participants
Primary outcome timeframe
Baseline
Results posted on
2022-07-08
Participant Flow
Participant milestones
| Measure |
Surveys Only
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
346
|
444
|
|
Overall Study
COMPLETED
|
323
|
437
|
|
Overall Study
NOT COMPLETED
|
23
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Baseline characteristics by cohort
| Measure |
Surveys Only
n=323 Participants
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=437 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.
|
Total
n=760 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
66.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
551 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
299 Participants
n=5 Participants
|
419 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
250 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
323 participants
n=5 Participants
|
437 participants
n=7 Participants
|
760 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data was not able to be collected for all participants.
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.
Outcome measures
| Measure |
Surveys Only
n=312 Participants
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=412 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.
|
|---|---|---|
|
Knowledge About Defibrillation at Baseline
|
53.4 score on a scale
Standard Deviation 17.6
|
55.4 score on a scale
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data was not able to be collected for all participants.
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.
Outcome measures
| Measure |
Surveys Only
n=253 Participants
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=370 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.
|
|---|---|---|
|
Knowledge About Defibrillation at 1 Month
|
57.1 score on a scale
Standard Deviation 18.2
|
58.0 score on a scale
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was not able to be collected for all participants.
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.
Outcome measures
| Measure |
Surveys Only
n=245 Participants
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=343 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.
|
|---|---|---|
|
Knowledge About Defibrillation at 6 Months
|
56.6 score on a scale
Standard Deviation 17.4
|
58.6 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: The control group did not receive the intervention, and was not analyzed for this outcome measure.
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Outcome measures
| Measure |
Surveys Only
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=437 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.
|
|---|---|---|
|
Reach of Eligible Patients
Were administered intervention by hospital
|
—
|
349 Participants
|
|
Reach of Eligible Patients
Were not administered intervention by hospital
|
—
|
88 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 6 monthsThe decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 6 monthsThe decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 6 monthsThe 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).
Outcome measures
Outcome data not reported
Adverse Events
Surveys Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Educational Video and/or Handout + Surveys
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surveys Only
n=346 participants at risk
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
|
Educational Video and/or Handout + Surveys
n=444 participants at risk
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.
|
|---|---|---|
|
Investigations
Incomplete consent process
|
33.3%
3/9 • Number of events 3 • 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.
|
0.00%
0/51 • 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.
|
Additional Information
Daniel Matlock, MD
University of Colorado Denver | Anschutz
Phone: 303-724-1111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place