Coronary Artery DiseaseNCT02652208
Comparative Effectiveness of Decision Aids for Stable Chest Discomfort
A study testing Online decision aid and Video decision aid in people with Coronary Artery Disease and Stable Angina, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Angina
- What is being tested?
- Online decision aid and Video decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 and older
- English speaking
- Current diagnosis of stable angina
- Ability to access online material and willing to provide an email address
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Stable Angina
- Being tested
- Online decision aid, Video decision aid
- Keywords
- decision making, decision aids, shared decision making, stable angina, cardiology
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online decision aidBehavioural
The Healthwise online shared decision point for Stable Chest Discomfort
Video decision aidBehavioural
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online decision aid |
| 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. Receives: Behavioral: Video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 week after reviewing the decision aid
Secondary outcomes (2)
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.
Measured: Within 1 week after reviewing the decision aid
Satisfaction With the Intervention
Number of respondents who rated the material as "very good" or "excellent".
Measured: Within 1 week after reviewing the decision aid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen R Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652208
- Sponsor's protocol ID
- 2014P002292
- Status last verified
- Aug 2017
- First submitted
- 8 Jan 2016
- Last updated
- 29 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17387127Rothberg 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.
PubMed 20820040Holmboe 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.
PubMed 11029677
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort
- ClinicalTrials.gov ID
- NCT02652208
- Acronym / sponsor ID
- 2014P002292
- Conditions
- Coronary Artery Disease, Stable Angina
- Keywords
- decision making, decision aids, shared decision making, stable angina, cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 29 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online decision aid | Active comparator | Behavioral: Online decision aidThis 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 | Behavioral: Video decision aidThis group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 and older
- English speaking
- Current diagnosis of stable angina
- Ability to access online material and willing to provide an email address
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online decision aidThe Healthwise online shared decision point for Stable Chest Discomfort | Behavioural | Online decision aid |
| Video decision aidThe Health Dialog DVD and booklet decision aid for Stable Chest Discomfort | Behavioural | Video decision aid |
Primary outcome
Total Knowledge Score
Time frame: 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.
2 secondary outcomes
Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)
Time frame: Within 1 week after reviewing the decision aid
Satisfaction With the Intervention
Time frame: Within 1 week after reviewing the decision aid
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17387127Boden 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.
- Background: PubMed 20820040Rothberg 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.
- Background: PubMed 11029677Holmboe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen R Sepucha, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online decision aid and Video decision aid in people with Coronary Artery Disease and Stable Angina, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Knowledge Score (time frame: Within 1 week after reviewing the decision aid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.