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Clinical Trials/NCT04755426
NCT04755426CompletedNot Applicable

Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis

Shared Decision Making Resources1 site in 1 country99 target enrollmentStarted: January 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
99
Locations
1
Primary Endpoint
Shared Decision Making Process Scale

Study Overview

Brief Summary

The overall goal of this study is to develop and validate a preference assessment tool for patients who have severe aortic stenosis and are contemplating their treatment options. The first part of the study focuses on understanding the treatment goals and treatment features that matter most to patients who have already made the decision. The investigators use mixed methods (nominal group technique, card sorting) to elicit, prioritize, and organize these patient preferences into a "cognitive map". Based on those findings, the investigators design a preference tool and then pre-test the tool with patients and healthcare providers.

Detailed Description

The investigators are conducting a 4-phase phase mixed methods study involving nominal group technique (NGT), with patients driving the identification and categorization of preferences regarding treatment options for symptomatic AS. Participants include adults with a history of symptomatic AS and HCPs who guide decisions about managing AS, including interventional cardiologists, cardiac surgeons and advanced practice providers (APPs), including nurse practitioners and physician assistants.

The initial phases of the study (generating patient goals and preferences through NGTs) targets diverse patients with a history of severe Aortic Stenosis (AS) who have previously made the decision regarding treatment choices. This will include patients who have undergone Surgical aortic valve replacement (SAVR), Transcatheter aortic valve replacement (TAVR), or who elected palliative care with or without balloon valvuloplasty. The subsequent phases will include patients with AS who are currently facing a decision with regard to treatment.

Phase 1: Identify and prioritize patient a) goals and b) preferences for treatment. The nominal group technique (NGT) will be used to identify and prioritize patient-centered outcomes related to treatment goals and treatment features. Both in-person and online NGT groups, with 5-9 patients each, will be conducted to maximize the representativeness of the sample (6-8 NGTs). Planning for 4 NGT's per question (8 total), including a minimum of 2 in-person NGTs (and the remaining conducted either in-person or online, depending on which approach better enables recruitment needs. Each NGT has between 5 and 9 patients. A separate parallel process will be done for each NGT question including a) goals and b) preferences for treatment attributes to limit patient burden for each portion of the study.

Phase 2: Categorize patient a) goals and b) preferences for treatment through cognitive mapping. Following identification and prioritization of patient-generated goals and preferences, 25-50 patients across the three sites will participate online in "card sorting" activities that will be used to organize these prioritized lists into clusters (domains), using Multidimensional Scaling (MDS) and Hierarchical Cluster Analysis (HCA) to analyze the data. A parallel process will be done for each cognitive map including a) goals and b) preferences for treatment.

Phase 3: Based on patient-defined goals and preferences for the treatment of AS, develop the preference assessment tool. The patient-identified goals and preferences will serve as the core of the preference tool. The investigators will draw from a validated SDM template to summarize and communicate patient preferences to their HCPs. An early prototype will be developed, and subsequent usability testing with patients with a history of severe AS will refine the tool. The prototype that will be used is available at: https://tinyurl.com/WhatMattersMS

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Symptomatic aortic stenosis (also known as severe aortic stenosis)
  • English-speaking
  • a patient of a participating HCP (for Phases 3 and 4)

Exclusion Criteria

  • 18 years of age or younger
  • unable or unwilling to give informed consent.

Outcomes

Primary Outcomes

Shared Decision Making Process Scale

Time Frame: Within a day or 2 of meeting with their valve specialist to discuss treatment options

A patient-reported measure of shared decision making with their clinician.

Secondary Outcomes

  • Knowledge (Subjective and objective)(At baseline, just after completing the tool, and within a day or 2 of meeting with their valve specialist.)
  • Patient-identified preferences for treatment.(At baseline, while using the tool, and within a day or 2 of meeting with their valve specialist to discuss treatment options)
  • Healthcare providers' perceptions of their patient's preferences.(WIthin a few days of having an appointment with the patient who has interacted with the tool.)
  • CollaboRATE(Within a day or 2 of meeting with their valve specialist to discuss treatment options)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nananda Col

Founder

Shared Decision Making Resources

Study Sites (1)

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