Heart DiseasesDECIDE-PCINCT02046902
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
An observational study of Heart Diseases, run by University of Missouri, Kansas City at 2 sites in United States.
Trial summary
The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- How many people
- 586 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to 31 Dec 2016
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with and without coronary artery disease
Who may be able to join
- >18 years old
- English or Spanish speaking
- Presence of coronary disease, or a caregiver/relative of one with coronary disease
Who cannot join
- non-English or non-Spanish speaking
- dementia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.
Read the detailed description
Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups.
Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making.
Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted.
Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.
- Conditions
- Heart Diseases
- Keywords
- coronary artery disease, cardiac stent, PCI procedure, Patient preference
- Medical subject headings
- Heart Diseases, Coronary Artery Disease, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart disease | Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention. | |
| Healthy adults | Adults without a diagnosis of coronary artery disease. Focus groups will be held. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching
The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"
Measured: 30 months
Secondary outcomes (1)
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.
Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don't care" or "I don't know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?"
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 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 (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, John A. Spertus, University of Missouri, Kansas City
- Investigators
- John A Spertus, MD, MPH, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046902
- Sponsor's protocol ID
- CE-1304-6448
- Acronym
- DECIDE-PCI
- Status last verified
- Jul 2019
- First submitted
- 22 Jan 2014
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We would be happy to collaborate with others to run analyses, but do not plan on freely distributing our data. You can see my editorial in CCQO to understand my concerns.
Publications
Chhatriwalla AK, Decker C, Gialde E, Catley D, Goggin K, Jaschke K, Jones P, deBronkart D, Sun T, Spertus JA. Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005139. doi: 10.1161/CIRCOUTCOMES.118.005139.
PubMed 30764654Qintar M, Chhatriwalla AK, Arnold SV, Tang F, Buchanan DM, Shafiq A, Pokharel Y, deBronkart D, Ashraf JM, Spertus JA. Beyond restenosis: Patients' preference for drug eluting or bare metal stents. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):357-363. doi: 10.1002/ccd.26946. Epub 2017 Feb 7.
PubMed 28168845
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
- ClinicalTrials.gov ID
- NCT02046902
- Acronym / sponsor ID
- DECIDE-PCI / CE-1304-6448
- Conditions
- Heart Diseases
- Keywords
- coronary artery disease, cardiac stent, PCI procedure, Patient preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.
Detailed description
Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups.
Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making.
Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted.
Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart disease | – | –Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention. |
| Healthy adults | – | –Adults without a diagnosis of coronary artery disease. Focus groups will be held. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with and without coronary artery disease
Key inclusion criteria (3 listed)
- >18 years old
- English or Spanish speaking
- Presence of coronary disease, or a caregiver/relative of one with coronary disease
Key exclusion criteria (2 listed)
- non-English or non-Spanish speaking
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching
Time frame: 30 months
The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"
1 secondary outcome
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30764654Chhatriwalla AK, Decker C, Gialde E, Catley D, Goggin K, Jaschke K, Jones P, deBronkart D, Sun T, Spertus JA. Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005139. doi: 10.1161/CIRCOUTCOMES.118.005139.
- Derived from this study: PubMed 28168845Qintar M, Chhatriwalla AK, Arnold SV, Tang F, Buchanan DM, Shafiq A, Pokharel Y, deBronkart D, Ashraf JM, Spertus JA. Beyond restenosis: Patients' preference for drug eluting or bare metal stents. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):357-363. doi: 10.1002/ccd.26946. Epub 2017 Feb 7.
- Individual participant dataSharing planned: Undecided. We would be happy to collaborate with others to run analyses, but do not plan on freely distributing our data. You can see my editorial in CCQO to understand my concerns.
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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.
John A Spertus, MD, MPH principal investigator
University of Missouri, Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by University of Missouri, Kansas City at 2 sites 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 3 inclusion and 2 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 24 Jul 2019). 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?
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (time frame: 30 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 NCT02046902, which also lists 2 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 6 Aug 2019.