Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04613934 |
| Other study ID # |
2019-08-0031 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2020 |
| Est. completion date |
October 16, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University of Texas at Austin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
