Trial Outcomes & Findings for Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use (NCT NCT00918125)

Results Overview

At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.

Recruitment status

COMPLETED

Target enrollment

59 participants

Primary outcome timeframe

1 week post intervention

Results posted on

2015-10-19

Participant Flow

Recruitment occurred at 3 centers: Duke University Medical Center, Alamance Regional Hospital; and Southeast Regional Medical Center in North Carolina. Patients were enrolled during 2011.

Participant milestones

Participant milestones
Measure	Standard of Care Patients in this arm received standard of care (counseling from a physician).	Video Intervention Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
Overall Study STARTED	20	39
Overall Study COMPLETED	20	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Black Patients n=22 Participants Patients who self-identified as African American	White Patients n=37 Participants Patients who self-identified as White	Total n=59 Participants Total of all reporting groups
Age, Continuous	52.4 Years STANDARD_DEVIATION 11.4 • n=5 Participants	61.7 Years STANDARD_DEVIATION 17.5 • n=7 Participants	58.2 Years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Randomization Allocation Video	15 participants n=5 Participants	24 participants n=7 Participants	39 participants n=5 Participants
Randomization Allocation Usual Care	7 participants n=5 Participants	13 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week post intervention

Population: All patients with available data at one week

At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.

Outcome measures

Outcome measures
Measure	Video n=39 Participants All patients who saw an educational video	Standard of Care n=17 Participants Usual care
Decision to Receive an ICD	28 Participants	14 Participants

SECONDARY outcome

Timeframe: one week post intervention

Population: Patients with data at one week

At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).

Outcome measures

Outcome measures
Measure	Video n=39 Participants All patients who saw an educational video	Standard of Care n=14 Participants Usual care
Decisional Conflict Scale	35.0 units on a scale Standard Deviation 2.9	34.1 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 3 months

Population: All patients with data at 3 months

Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.

Outcome measures

Outcome measures
Measure	Video n=22 Participants All patients who saw an educational video	Standard of Care n=37 Participants Usual care
Receipt of an ICD	14 participants	33 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: one week post intervention

Population: Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.

We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.

Outcome measures

Outcome measures
Measure	Video n=22 Participants All patients who saw an educational video	Standard of Care n=37 Participants Usual care
Mean Knowledge Scores About ICD Therapy One Week Post Intervention.	9.9 units on a scale Standard Deviation 2.5	10.4 units on a scale Standard Deviation 3.0

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kevin Thomas

Duke University Medical Center

Phone: 919-668-7857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place