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临床试验/NCT04755426
NCT04755426已完成不适用

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

Shared Decision Making Resources1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
1
主要终点
Shared Decision Making Process Scale

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Shared Decision Making Process Scale

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nananda Col

Founder

Shared Decision Making Resources

研究点 (1)

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