Aortic StenosisIMPACT SDMNCT06171737
Promoting Shared Decision Making for Severe Aortic Stenosis
A study testing Decision Aid and Shared Decision Making Skills Training in people with Aortic Stenosis, run by Massachusetts General Hospital at 8 sites in United States.
Trial summary
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: Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Decision Aid and Shared Decision Making Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Mar 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Between 65-85 years of age
- Language is English or Spanish
- Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area < 1 cm2 or as determined by clinician)
- Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Who cannot join
- Prior aortic valve replacement surgery
- High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score >8% or clinician determined)
- Prior coronary artery bypass surgery (CABG)
- End stage renal disease on dialysis
- Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
- Advanced Cirrhosis
- Unable to consent for self (proxy respondents are not allowed)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30308-0000
University of Colorado Denver
Aurora, Colorado, 80045-7202
Massachusetts General Hospital
Boston, Massachusetts, 02114
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1350
UT Southwestern Medical Center
Dallas, Texas, 75390-9020
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Regents of the University of California, San Francisco
San Francisco, California, 94117
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)
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:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
Read more
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.
Read the detailed description
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:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
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.
- Conditions
- Aortic Stenosis
- Being tested
- Decision Aid, Shared Decision Making Skills Training
- Keywords
- aortic valve stenosis, Decision Making, Shared, decision aid, continuing medical education, cardiology, Transcatheter Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
Shared Decision Making Skills TrainingBehavioural
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Decision Aid; Behavioral: Shared Decision Making Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
Measured: About 1 week post visit
Secondary outcomes (8)
Reach
% of eligible patients who receive decision aid
Measured: About 1 week post visit
Patient Knowledge
Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge
Measured: About 1 week post visit
Preference-treatment concordance
% of patients who received preferred treatment within 6 months of visit
Measured: About 1 week post visit
Patient experience
CAHPS MD-patient communication subscale and visit rating score
Measured: About 1 week post visit
Clinician satisfaction
% of clinicians who mark "very" or "extremely" satisfied with visit
Measured: About 1 week post visit
Adoption
% of eligible clinicians who complete the shared decision making skills training
Measured: 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"
Measured: About 1 week post visit
Timeliness (burden)
% of visits where clinicians report visit length is "longer than normal"
Measured: About 1 week post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start27 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 Aortic StenosisStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of Colorado, Denver, University of North Carolina, Chapel Hill, Emory University, University of Pennsylvania, University of Texas Southwestern Medical Center, University of Washington, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General HospitalSammy Elmariah, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171737
- Sponsor's protocol ID
- 2023P001413
- Acronym
- IMPACT SDM
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39696639
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)
- ClinicalTrials.gov ID
- NCT06171737
- Acronym / sponsor ID
- IMPACT SDM / 2023P001413
- Conditions
- Aortic Stenosis
- Keywords
- aortic valve stenosis, Decision Making, Shared, decision aid, continuing medical education, cardiology, Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Colorado, Denver, University of North Carolina, Chapel Hill, Emory University, University of Pennsylvania, University of Texas Southwestern Medical Center, University of Washington, Patient-Centered Outcomes Research Institute
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 Dec 2023 (actual)
- 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.
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:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
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.
Detailed description
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:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Decision Aid, Behavioral: Shared Decision Making Skills TrainingThe 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 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Between 65-85 years of age
- Language is English or Spanish
- Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area < 1 cm2 or as determined by clinician)
- Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Key exclusion criteria (7 listed)
- Prior aortic valve replacement surgery
- High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score >8% or clinician determined)
- Prior coronary artery bypass surgery (CABG)
- End stage renal disease on dialysis
- Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
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 AidThe American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery | Behavioural | Intervention |
| Shared Decision Making Skills Training60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies | Behavioural | Intervention |
Primary outcome
Shared Decision Making
Time frame: About 1 week post visit
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
8 secondary outcomes
Reach
Time frame: About 1 week post visit
Patient Knowledge
Time frame: About 1 week post visit
Preference-treatment concordance
Time frame: About 1 week post visit
Patient experience
Time frame: About 1 week post visit
Clinician satisfaction
Time frame: About 1 week post visit
Adoption
Time frame: 4 weeks from the start of intervention period for each site
Timeliness (time to decision)
Time frame: About 1 week post visit
Timeliness (burden)
Time frame: About 1 week post visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 39696639Sepucha 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
Sammy Elmariah, MD principal investigator
University of California, San Francisco
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid and Shared Decision Making Skills Training in people with Aortic Stenosis, run by Massachusetts General Hospital at 8 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
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?
Shared Decision Making (time frame: About 1 week post visit). 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 NCT06171737, 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 30 Sep 2026.