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临床试验/NCT04613934
NCT04613934已完成不适用

Redesigning the Care Journey of Patients With Single-ventricle Congenital Heart Disease

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2020年2月4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
142
试验地点
1
主要终点
Identification of areas to be improved in patient and families' journey

研究概览

简要总结

In this three-party collaboration, which includes The Texas Center for Pediatric and Congenital Heart Disease, the Value Institute for Health and Care, and the Design Institute for Health, all from University of Texas (UT) Dell Medical School, the investigators will explore how patient insights, data, storytelling, ideation, and prototyping can be employed to design a care delivery solution that enables patient outcome improvement. The goal of this project is to understand the life journey of patients with single-ventricle congenital heart disease and understand areas of that journey that can be improved. As such, the project intentionally does not start with a hypothesis, but instead seeks to gain insight of single-ventricle patients' care journey and based on that understanding identify opportunities for improvement.

详细描述

This collaborative research will utilize the Experience Group and Contextual Interview, two qualitative research methodologies, in order to understand and improve patients' and families with single-ventricle congenital heart disease (CHD) journey in care. There will be six main groups participating in the study: 1. Patients age 6 and older with a diagnosis of single-ventricle congenital heart disease; 2. Siblings (age 6 and older) of patients with single-ventricle CHD; 3. Parents or legal guardians of patients with single-ventricle CHD (regardless of patient age); 4. Pregnant parents who have a received a prenatal diagnosis of single-ventricle CHD; 5. Parents of deceased patients with single-ventricle CHD; 6. Adult partners of adult single-ventricle CHD patients.

Participants will take part in an Experience Group. The Experience Group methodology is a form of qualitative research that brings together a group of 4-8 people who share similar medical circumstances for a conversation. This methodology has been successfully used by researchers from the Value Institute for Health and Care to gain insights in different patient populations. The groups will take place at Dell Medical School, The Dell Pediatric Research Institute (across the street from Dell Children's Medical Center), or other convenient public location as needed to allow for the least amount of travel for participants. Each group lasts 60-90 minutes and encourages participants to discuss their conditions and experiences outside the hospital/clinic, specifically. Focusing on the lifestyle aspect of the patient experience enables insight into both the successes and the challenges faced outside the health care system and in unobservable situations. Conversation is encouraged by the facilitator, who offers topics such as "what makes a good/bad day?", "what are your aspirations, what are your fears?", and "what are some of the obstacles and burdens you face on a regular basis?" Using a research approach that employs semi-structured, open-ended questions directed towards the group as a whole, the investigators hope to learn about the unarticulated, unmet needs of these patients, both physical and emotional, and ranging both within and outside of the clinic. Participants will not be asked to take part in more than one Experience Group session. Due to the current COVID-19 pandemic, Experience Group sessions will be held virtually via Zoom.

Participants can elect to participate in a follow-up Contextual Interview following the Experience Groups. If the participants provide consent, they may be contacted for an interview. Not every patient that consents for participation will be asked to participate. Contextual Interviews will take place in participant's homes, or any other place of their choosing where they feel comfortable. Contextual Interviews will be performed by up to three personnel from the Design Institute for Health. The Design Institute has used this methodology extensively to identify needs and insights from patients to redesign care. Upon completion and approval of the optional model release part of the informed consent, audio recordings and photos may be taken. The Contextual Interviews do not follow a rigid question / answer scheme. Instead, their tone is conversational. Interview prompts will center around challenges the patients and families faced in their journey with CHD. Example questions may include, "When did you first receive the diagnosis?", "How do you feel about the care you were receiving?", "What, if anything, did the care team do to make you feel cared for?", "How did you feel about the location/environment?", and "What, if anything could have been different, improved or better for you?" Participants will not be asked to take part in more than one Contextual Interview session. Due to the current COVID-19 pandemic, Contextual Interviews will take place virtually via Zoom.

Finally, some participants will have the opportunity to take part in virtual workshops to discuss the challenges uncovered in the Experience Groups and Contextual Interviews and ideate potential solutions to such challenges. Workshops are ideation meetings lasting from a few hours to a full day and would include stakeholders from all three collaborators and patient and family representatives, if appropriate. Participants in workshops will be asked to comment on research insights, participate in ideation sessions (brainstorms), sketch and write up ideas and evaluate different service design concepts.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients with any diagnosis of single-ventricle congenital heart disease, age 6 and older
  • Parents or legal guardians of patients at any age with any diagnosis of single-ventricle congenital heart disease
  • Siblings of patients with any diagnosis of single-ventricle congenital heart disease, age 6 and older
  • Pregnant parents who have gotten any prenatal diagnosis of single-ventricle congenital heart disease
  • Adult partners of adult patients with any diagnosis of single-ventricle congenital heart disease

排除标准

  • Patients with a cognitive disability that prevents completion of the study procedures
  • Patients, family members, and partners who do not speak English or Spanish

结局指标

主要结局

Identification of areas to be improved in patient and families' journey

时间窗: 2 years

This is a qualitative research study. The investigators are using a combination of Experience Group sessions, Contextual Interviews and workshops with patients and their family members to obtain information to identify areas of the lifelong journey of patient with single-ventricle congenital heart disease and their families that can be redesigned to improve the outcomes that matter most to the patients and their families

次要结局

未报告次要终点

研究者

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

Carlos Miguel Mery

Associate Professor

University of Texas at Austin

研究点 (1)

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