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Completed

NCT Number: NCT04103931

Impact 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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver I Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention

Treatment and study plan

"Treatment Choices for Aortic Stenosis" Decision Aid

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Shared Decision Making Process score

    Time frame: About 1 week after receiving the decision aid

    Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making.

  2. Treatment Preference

    Time frame: About 1 week after receiving the decision aid

    Patients will indicate their preferred treatment (TAVR, surgery, or unsure)

  3. Treatment received

    Time frame: 12-21 weeks post visit

    Chart review will determine type of treatment received (e.g. TAVR, SAVR, other)

Other outcomes

  1. SURE scale

    Time frame: About 1 week after receiving the decision aid

    The 4 item SURE scale will measure decisional conflict and the percent with the top score (4 out of 4) will be reported

  2. CollaboRATE scale

    Time frame: About 1 week after the visit

    The 3 item Collaborate scale will be scored and the percent receiving the top score (27 out of 27) will be reported

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2019
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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