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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Colorado, Denver | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| Emory University |
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The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
The goal of this study is to promote shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (usual care) | No Intervention | This group will receive usual care without any support for using the decision aid and without any access to the clinician training. | |
| Intervention | Active Comparator | The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Behavioral | The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shared Decision Making | Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred. | About 1 week post visit |
| Measure | Description | Time Frame |
|---|---|---|
| Reach | % of eligible patients who receive decision aid | About 1 week post visit |
| Patient Knowledge | Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Sammy Elmariah, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Regents of the University of California, San Francisco | San Francisco | California | 94117 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39696639 | Derived | Sepucha K, Elmariah S, Valentine KD, Cavender MA, Chang Y, Devireddy CM, Dickert NW, Gama KD, Knoepke CE, Korngold E, Kumbhani DJ, Matlock DD, Messenger JC, Strong S, Thourani VH, Nathan A, Quader N, Brescia AA. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study: study protocol for a cluster randomized stepped wedge trial. Trials. 2024 Dec 18;25(1):820. doi: 10.1186/s13063-024-08640-6. |
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To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available, or at the time of publication the primary results, whichever comes first.
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| OTHER |
| University of Pennsylvania | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| University of Washington | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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There is limited blinding in the trial due to the pragmatic focus and batched stepped wedge design. Patients will be told that the study is testing different types of decision support and while they will not be blinded to the materials they receive, they will not know what materials other patients receive. Clinicians and staff will be involved in delivery of the decision aids and will not be blinded to the study arm. Research staff entering survey data and conducting chart review will not be given any explicit information about study assignment; however, it is likely that they will have a sense for the arm due to the timing. The statistician conducting analyses will be blinded to group assignment at each step. For the clinician survey, we will use computer generated random assignment to select one specialist (either interventional cardiologist or cardiac surgeon) to receive the post-visit survey for each patient participant.
| Shared Decision Making Skills Training | Behavioral | 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
|
| About 1 week post visit |
| Preference-treatment concordance | % of patients who received preferred treatment within 6 months of visit | About 1 week post visit |
| Patient experience | CAHPS MD-patient communication subscale and visit rating score | About 1 week post visit |
| Clinician satisfaction | % of clinicians who mark "very" or "extremely" satisfied with visit | About 1 week post visit |
| Adoption | % of eligible clinicians who complete the shared decision making skills training | 4 weeks from the start of intervention period for each site |
| Timeliness (time to decision) | % of patients who report stage of decision making is "made a decision" | About 1 week post visit |
| Timeliness (burden) | % of visits where clinicians report visit length is "longer than normal" | About 1 week post visit |
| University of Colorado Denver |
| Aurora |
| Colorado |
| 80045-7202 |
| United States |
| Emory University | Atlanta | Georgia | 30308-0000 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-1350 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-9020 | United States |
| D014694 |
| Ventricular Outflow Obstruction |