Aortic Valve StenosisNCT04103931
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
A study testing "Treatment Choices for Aortic Stenosis" Decision Aid in people with Aortic Valve Stenosis, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- "Treatment Choices for Aortic Stenosis" Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2019to 1 Sep 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-85 years only
- English speaking
- Severe aortic stenosis, defined as an aortic valve area < 1 cm2
- Never had AVR or who had previous AVR > 6 months previous
- Patients perceived by the clinician to be at low or intermediate risk for SAVR
Who cannot join
- Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver I Anschutz Medical Campus
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).
Read the detailed description
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.
- Conditions
- Aortic Valve Stenosis
- Being tested
- "Treatment Choices for Aortic Stenosis" Decision Aid
- Keywords
- Shared Decision Making
- 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.
"Treatment Choices for Aortic Stenosis" Decision AidBehavioural
A decision aid, titled "Treatment Choices for Aortic Stenosis," produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will receive usual care and will not get the decision aid to review. |
| Patient Decision Aid | Experimental | Participants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review. Receives: Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score
Patients will complete 6 multiple choice knowledge items and a total knowledge score (0-100%) will be created by summing the number of correct responses and dividing by the number of items.
Measured: About 1 week after receiving the decision aid
Secondary outcomes (3)
Shared Decision Making Process score
Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making.
Measured: About 1 week after receiving the decision aid
Treatment Preference
Patients will indicate their preferred treatment (TAVR, surgery, or unsure)
Measured: About 1 week after receiving the decision aid
Treatment received
Chart review will determine type of treatment received (e.g. TAVR, SAVR, other)
Measured: 12-21 weeks post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start23 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- Parallel groups
- Model description
- Patients are randomly assigned to receive the decision aid or usual care.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- 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
- NCT04103931
- Sponsor's protocol ID
- 2017P001883
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will create a complete, cleaned, de-identified copy of the final data set.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04103931
- Acronym / sponsor ID
- 2017P001883
- Conditions
- Aortic Valve Stenosis
- Keywords
- Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 26 Sep 2019 (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.
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).
Detailed description
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to receive the decision aid or usual care.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will receive usual care and will not get the decision aid to review. |
| Patient Decision Aid | Experimental | Behavioral: "Treatment Choices for Aortic Stenosis" Decision AidParticipants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-85 years only
- English speaking
- Severe aortic stenosis, defined as an aortic valve area < 1 cm2
- Never had AVR or who had previous AVR > 6 months previous
- Patients perceived by the clinician to be at low or intermediate risk for SAVR
Key exclusion criteria (1 listed)
- Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention
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 |
|---|---|---|
| "Treatment Choices for Aortic Stenosis" Decision AidA decision aid, titled "Treatment Choices for Aortic Stenosis," produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis. | Behavioural | Patient Decision Aid |
Primary outcome
Knowledge score
Time frame: About 1 week after receiving the decision aid
Patients will complete 6 multiple choice knowledge items and a total knowledge score (0-100%) will be created by summing the number of correct responses and dividing by the number of items.
3 secondary outcomes
Shared Decision Making Process score
Time frame: About 1 week after receiving the decision aid
Treatment Preference
Time frame: About 1 week after receiving the decision aid
Treatment received
Time frame: 12-21 weeks post visit
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 5 Jan 2022.
- Individual participant dataSharing planned: Yes. The study team will create a complete, cleaned, de-identified copy of the final data set.
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Treatment Choices for Aortic Stenosis" Decision Aid in people with Aortic Valve Stenosis, run by Massachusetts General Hospital 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 5 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 5 Jan 2022. 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?
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?
Knowledge score (time frame: About 1 week after receiving the decision aid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2022.