Trial Outcomes & Findings for Comparative Effectiveness of Decision Aids for Stable Chest Discomfort (NCT NCT02652208)

Last Updated: 2017-08-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Within 1 week after reviewing the decision aid

Results posted on

2017-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	17	17
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Online Decision Aid n=13 Participants 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	Video Decision Aid n=15 Participants 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	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 10.2 • n=5 Participants	73 years STANDARD_DEVIATION 11.6 • n=7 Participants	70 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	15 Participants n=7 Participants	28 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 week after reviewing the decision aid

Population: All participants who completed and returned a survey within the 6 month study period.

Outcome measures

Outcome measures
Measure	Online Decision Aid n=12 Participants 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	Video Decision Aid n=15 Participants 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
Total Knowledge Score	2.83 knowledge score Standard Deviation 0.72	4.0 knowledge score Standard Deviation 1.46

SECONDARY outcome

Timeframe: Within 1 week after reviewing the decision aid

Population: Only participants who indicated they currently had symptoms were asked to complete the item

To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.

Outcome measures

Outcome measures
Measure	Online Decision Aid n=6 Participants 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	Video Decision Aid n=8 Participants 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
Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 1 week after reviewing the decision aid

Population: All participants who completed and returned a survey within the 6 month study period.

Number of respondents who rated the material as "very good" or "excellent".

Outcome measures

Outcome measures
Measure	Online Decision Aid n=13 Participants 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	Video Decision Aid n=15 Participants 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
Satisfaction With the Intervention	6 Participants	10 Participants

Adverse Events

Online Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Video Decision Aid

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. Karen Sepucha

Massachusetts General Hospital

Phone: 617-724-3350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place