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

Study Overview
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Brief Summary
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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
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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 Phase 4: Pilot test the preference assessment tool using 20-25 patient-HCP pairs to compare HCPs' prediction of patient preferences to actual patient preferences, among those patients who have not yet received treatment for their AS. Before each clinical encounter, each HCP will be asked to infer their patient's top 1-3 treatment goals and preferences. Patients will have interacted with the preference assessment tool independently before the clinical appointment, which will have assessed and summarized their goals and preferences. After the HCP has entered his/her inferred patient treatment goals, he/she will be shown the patient's actual treatment goals and preferences. Analyses will compare the correspondence between the patient and HCP preferences (using Kappa statistic). Additionally, the outcomes below will be assessed in preparation for the subsequent national validation study.

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

Conditions
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Aortic Stenosis Symptomatic

Intervention / Treatment
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* Behavioral: AVITA--Aortic Valve Improved Treatment Approaches


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with severe aortic stenosis<br>Adults with severe aortic stenosis who either have faced or are facing a decision about valve replacement (depending on the phase of the research) | Behavioral: AVITA--Aortic Valve Improved Treatment Approaches<br>* AVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist.<br>* Other names: Shared decision making tool;|
| Health care providers<br>HCPs who guide decisions about managing AS, including interventional cardiologists, cardiac surgeons and advanced practice providers (APPs), including nurse practitioners and physician assistants. | Behavioral: AVITA--Aortic Valve Improved Treatment Approaches<br>* AVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist.<br>* Other names: Shared decision making tool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making Process Scale | A patient-reported measure of shared decision making with their clinician. | Within a day or 2 of meeting with their valve specialist to discuss treatment options | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-identified preferences for treatment. | The treatment for aortic stenosis that the patient prefers (SAVR, TAVR, Medical Therapy, or undecided. | 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. | The features (attributes) of their treatment options for aortic stenosis that matter most to the patient | WIthin a few days of having an appointment with the patient who has interacted with the tool. | 
| CollaboRATE | A short patient-reported measure of patient-provider communication | Within a day or 2 of meeting with their valve specialist to discuss treatment options | 
| Knowledge (Subjective and objective) | Multiple choice questions that assess perceived and actual knowledge about aortic stenosis and treatment options. | At baseline, just after completing the tool, and within a day or 2 of meeting with their valve specialist. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared decision making, Preference assessment, Values clarification