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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online decision aid | Active Comparator | This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort. |
|
| Video decision aid | Active Comparator | This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online decision aid | Behavioral | The Healthwise online shared decision point for Stable Chest Discomfort |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1 week after reviewing the decision aid |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1 week after reviewing the decision aid |
| Satisfaction With the Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen R Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17387127 | Background | Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26. | |
| 20820040 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Video Decision Aid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed and returned a survey within the 6 month study period. | Posted | Mean | Standard Deviation | knowledge score | Within 1 week after reviewing the decision aid |
|
Serious and other (not including serious) adverse events were not collected/assessed as part of this survey study
The survey study examining patient reactions to educational materials did not collect adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Sepucha | Massachusetts General Hospital | 617-724-3350 | ksepucha@partners.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Video decision aid | Behavioral | The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort |
|
Number of respondents who rated the material as "very good" or "excellent". |
| Within 1 week after reviewing the decision aid |
| Background |
| Rothberg MB, Sivalingam SK, Ashraf J, Visintainer P, Joelson J, Kleppel R, Vallurupalli N, Schweiger MJ. Patients' and cardiologists' perceptions of the benefits of percutaneous coronary intervention for stable coronary disease. Ann Intern Med. 2010 Sep 7;153(5):307-13. doi: 10.7326/0003-4819-153-5-201009070-00005. |
| 11029677 | Background | Holmboe ES, Fiellin DA, Cusanelli E, Remetz M, Krumholz HM. Perceptions of benefit and risk of patients undergoing first-time elective percutaneous coronary revascularization. J Gen Intern Med. 2000 Sep;15(9):632-7. doi: 10.1046/j.1525-1497.2000.90823.x. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | Only participants who indicated they currently had symptoms were asked to complete the item | Posted | Count of Participants | Participants | Within 1 week after reviewing the decision aid |
|
|
|
| Secondary | Satisfaction With the Intervention | Number of respondents who rated the material as "very good" or "excellent". | All participants who completed and returned a survey within the 6 month study period. | Posted | Count of Participants | Participants | Within 1 week after reviewing the decision aid |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |