NCT04103931

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

September 24, 2019

Last Update Submit

December 14, 2021

Conditions

Aortic Valve Stenosis

Keywords

Shared Decision Making

Outcome Measures

Primary Outcomes (1)

  • 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.

    About 1 week after receiving the decision aid

Secondary Outcomes (3)

  • Shared Decision Making Process score

    About 1 week after receiving the decision aid

  • Treatment Preference

    About 1 week after receiving the decision aid

  • Treatment received

    12-21 weeks post visit

Other Outcomes (2)

  • SURE scale

    About 1 week after receiving the decision aid

  • CollaboRATE scale

    About 1 week after the visit

Study Arms (2)

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.

Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid

Interventions

"Treatment Choices for Aortic Stenosis" Decision AidBEHAVIORAL

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.

Patient Decision Aid

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver I Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Karen R Sepucha, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Patients are randomly assigned to receive the decision aid or usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

September 23, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

January 5, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

The study team will create a complete, cleaned, de-identified copy of the final data set.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data will be made available to outside investigators starting 6 months after publication.
Access Criteria
Information about the data sets will be on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH)/ Mass General Brigham policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board (IRB) requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.

Locations

US(2)