Stable AnginaNCT01771536
The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
A study testing Decision Aid in people with Stable Angina, run by Mayo Clinic at 1 site in United States.
Trial summary
Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision
Who cannot join
- has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)
Trial locations and contacts
1 site in 1 country.
About this study
Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.
This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.
- Conditions
- Stable Angina
- Being tested
- Decision Aid
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
| Study group | Role | What they receive |
|---|---|---|
| PCI Choice decision | Active comparator | Decision Aid intervention is provided to clinician to share with patient Receives: Other: Decision Aid |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings
Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid.
Measured: Baseline to Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilay Shah, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771536
- Sponsor's protocol ID
- 12-004554
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2012
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):767-776. doi: 10.1161/CIRCOUTCOMES.116.002641. Epub 2016 Nov 1.
PubMed 27803090
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01771536
- Acronym / sponsor ID
- 12-004554
- Conditions
- Stable Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.
This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI Choice decision | Active comparator | Other: Decision AidDecision Aid intervention is provided to clinician to share with patient |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision
Key exclusion criteria (1 listed)
- has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)
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 |
|---|---|---|
| Decision Aid | Other | PCI Choice decision |
Primary outcome
Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings
Time frame: Baseline to Three Months
Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 27803090Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):767-776. doi: 10.1161/CIRCOUTCOMES.116.002641. Epub 2016 Nov 1.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Nilay Shah, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Stable Angina, run by Mayo Clinic 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 1 inclusion and 1 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 15 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (time frame: Baseline to Three Months). 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 NCT01771536, which also lists 1 linked publication.
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 15 Mar 2023.