Trial Outcomes & Findings for Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy (NCT NCT02819973)
NCT ID: NCT02819973
Last Updated: 2021-04-21
Results Overview
Proportion of patients who have decided by 7 days to receive an ICD among patients randomized to the video intervention compared with health care provider counseling (usual care)
COMPLETED
NA
343 participants
7 days
2021-04-21
Participant Flow
Participant milestones
| Measure |
Racially Concordant Video
Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant
|
Racially Discordant Video
Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant.
|
Usual Care (No Video)
Standard Care/ No video
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
114
|
115
|
|
Overall Study
COMPLETED
|
108
|
111
|
111
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
Baseline characteristics by cohort
| Measure |
Racially Concordant Video
n=108 Participants
Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant.
|
Racially Discordant Video
n=111 Participants
Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant
|
Usual Care (no Video)
n=111 Participants
Standard Care/ No video
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
n=99 Participants
|
59.0 years
n=107 Participants
|
60.1 years
n=206 Participants
|
59.3 years
n=7 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
63 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
208 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
108 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
330 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=99 Participants
|
111 participants
n=107 Participants
|
111 participants
n=206 Participants
|
330 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
Proportion of patients who have decided by 7 days to receive an ICD among patients randomized to the video intervention compared with health care provider counseling (usual care)
Outcome measures
| Measure |
Video
n=210 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=101 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Proportion of Patients Saying "Yes" to ICD
Yes, want an ICD
|
123 Participants
|
60 Participants
|
|
Proportion of Patients Saying "Yes" to ICD
No or unsure about an ICD
|
87 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All participants randomized to video arm for whom outcome data is available. Usual care arm is excluded from this outcome to measure the impact of racial concordance among those viewing a video.
Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD
Outcome measures
| Measure |
Video
n=102 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=108 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video
Yes, want an ICD
|
54 Participants
|
69 Participants
|
|
Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video
No or unsure about an ICD
|
48 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline preintervention and Baseline (approximately 20mins later) post interventionPopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs.
Outcome measures
| Measure |
Video
n=218 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=111 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Changes in Patient Knowledge (Pre and Post Intervention)
Pre-intervention knowledge score
|
6.0 score on a scale
Standard Deviation 2.6
|
6.1 score on a scale
Standard Deviation 2.8
|
|
Changes in Patient Knowledge (Pre and Post Intervention)
Post-intervention knowledge score
|
9.0 score on a scale
Standard Deviation 1.9
|
8.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline pre intervention and 1 week post interventionPopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified time point. Video arms were combined into a single group to measure the impact of video vs. no video.
Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD.
Outcome measures
| Measure |
Video
n=218 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=111 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Changes in Decisional Conflict (Pre and Post)
Score baseline pre-intervention
|
34.4 score on a scale
Interval 25.0 to 44.9
|
37.5 score on a scale
Interval 25.0 to 46.9
|
|
Changes in Decisional Conflict (Pre and Post)
Score 1 week post-intervention
|
25.0 score on a scale
Interval 12.5 to 28.1
|
25.0 score on a scale
Interval 17.2 to 31.2
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video.
Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review.
Outcome measures
| Measure |
Video
n=219 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=110 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
ICD Receipt Within 90 Days of Enrollment.
|
142 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer
Outcome measures
| Measure |
Video
n=201 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=110 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Time Spent With Patients by Providers in Each Arm of the Study
|
18.0 minutes
Interval 9.0 to 31.0
|
20.0 minutes
Interval 12.0 to 39.0
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video.
Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs.
Outcome measures
| Measure |
Video
n=211 Participants
Participants randomized to watch a video about ICDs
|
Usual Care (no Video)
n=102 Participants
Participants randomized to usual care with no video
|
|---|---|---|
|
Patient Knowledge
|
9.0 score on a scale
Interval 7.0 to 10.0
|
8.0 score on a scale
Interval 6.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 MonthIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekIn-depth phone interview
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekIn-depth phone interview
Outcome measures
Outcome data not reported
Adverse Events
Educational Video 1
Educational Video 2
Usual Care (no Video) 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place