Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05111639 |
Other study ID # |
21-3661.cc |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 24, 2021 |
Est. completion date |
June 22, 2025 |
Study information
Verified date |
March 2024 |
Source |
University of Colorado, Denver |
Contact |
Ashley Dafoe |
Phone |
3037240838 |
Email |
ashley.dafoe[@]cuanschutz.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This proposal will aim to improve the understanding about the treatment decision in the type
of urinary diversion and identify patient knowledge gaps about uncertainty around patient
decision-making.
Description:
The Investigator aims to elicit the patient and provider experiences through conducting a
90-minute interview, using an interview guide the research team has developed, using
established qualitative research methods for in-depth individual interviews. The team will
structure the interviews with broad, open-ended questions to elicit personal thoughts,
emotions and experiences regarding decision making for urinary diversion. The team will use
the information collected from this interview to make a tool valuable in developing a patient
decision aid. For patients who have not undergone surgery yet, the team will ask the patient
if it is okay to contact after their surgery to reassess the patients responses to the same
questions from the first interview.
In Aim 2, the team will complete part one of the Ottawa decision framework by assessing the
patients' and urologists' determinates of decisions for urinary diversion and identify
support needs. Using established qualitative research methods for in-depth individual
interviews, the team will structure the interviews with broad, open-ended questions to elicit
personal thoughts, emotions and experiences regarding decision making for urinary diversion.
Informed by Aim 2 the team will develop a web-based development of a decision aid. The
development process will use both the Ottawa decision support and IPDAS to center the design
empathetic to the user. The aim will be consistent with principles where the users take
priority in the IPDAS guidelines framework and the needs assessment framework. The team will
develop a decision support tailored to patients needs who are undergoing urinary diversion
and then evaluate the decision making process. The decision aid will use the preferences from
the themes of the individual interviews to give patients a preferred method of urinary
diversion. The team will perform this in a pre-post fashion.
As mentioned previously, patients will be recruited from the urologists' clinical work. The
Indiana and Neobladder patients may have different vantage points in the perioperative
period, however at 6-months this should no longer be different. In addition, the team will
have patients use the decision aid at 1-month postoperatively to obtain feedback. Getting
patient feedback from the group will be critical with such a large number of patients
recruited. The research assistant will identify eligible patients prior to their clinic
encounter and obtain informed consent. Patients will then complete the decision aid prior to
the visit with the surgeon and bring the completed tool into the clinical encounter. After
completing the visit, the patient and research assistant will complete the questionnaires
assessing acceptability, knowledge, treatment decision and decisional conflict. One month
after surgery, our team will also complete the same questionnaires, as well as patient
satisfaction and regret at the 6-month follow-up visit. If patients are not available for the
visit, our team will attempt to complete telehealth or telephone interviews.