Coronary Artery Disease, Stable Angina
Conditions
Keywords
decision making, decision aids, shared decision making, stable angina, cardiology
Brief summary
The purpose of the study is to compare two different types of decision support materials for patients considering treatment for chest pain or chest discomfort from heart disease.
Detailed description
The purpose of the project is to compare the effectiveness of a detailed, video patient decision aid and an online, interactive patient decision aid for treatment of Stable Chest Discomfort. The study will randomly assign eligible participants to receive either the online decision aid or the video decision aid. Participants will complete a survey after reviewing the decision aid that will examine decision quality, use of the intervention, and satisfaction with the intervention.
Interventions
BEHAVIORALOnline decision aid
The Healthwise online shared decision point for Stable Chest Discomfort
BEHAVIORALVideo decision aid
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 and older * English speaking * Current diagnosis of stable angina * Ability to access online material and willing to provide an email address
Exclusion criteria
* Coronary bypass surgery and/or percutaneous coronary intervention within 6 months * Diagnosis of unstable angina, acute coronary syndrome, STEMI, non STEMI within 6 months * Scheduled for nonelective catheterization * Significant cognitive deficit such that participant is unable to consent for self * Serious comorbidities or other conditions that make revascularization inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Knowledge Score | Within 1 week after reviewing the decision aid | Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference) | Within 1 week after reviewing the decision aid | To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort. |
| Satisfaction With the Intervention | Within 1 week after reviewing the decision aid | Number of respondents who rated the material as very good or excellent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Online Decision Aid This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort | 13 |
| Video Decision Aid This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Online Decision Aid | Video Decision Aid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 12 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 10.2 | 73 years STANDARD_DEVIATION 11.6 | 70 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 15 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 15 Participants | 27 Participants |
| Region of Enrollment United States | 13 participants | 15 participants | 28 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Total Knowledge Score
Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better.
Time frame: Within 1 week after reviewing the decision aid
Population: All participants who completed and returned a survey within the 6 month study period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Decision Aid | Total Knowledge Score | 2.83 knowledge score | Standard Deviation 0.72 |
| Video Decision Aid | Total Knowledge Score | 4.0 knowledge score | Standard Deviation 1.46 |
Secondary
Satisfaction With the Intervention
Number of respondents who rated the material as very good or excellent.
Time frame: Within 1 week after reviewing the decision aid
Population: All participants who completed and returned a survey within the 6 month study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Decision Aid | Satisfaction With the Intervention | 6 Participants |
| Video Decision Aid | Satisfaction With the Intervention | 10 Participants |
Secondary
Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)
To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.
Time frame: Within 1 week after reviewing the decision aid
Population: Only participants who indicated they currently had symptoms were asked to complete the item
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Decision Aid | Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference) | 4 Participants |
| Video Decision Aid | Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference) | 5 Participants |