Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06184919 |
| Other study ID # |
2022-1516 |
| Secondary ID |
A539707SMPH/SURG |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 14, 2023 |
| Est. completion date |
April 30, 2028 |
Study information
| Verified date |
March 2024 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The researchers will conduct observations, interviews, and focus groups with clinicians,
staff and patients of the Perioperative Optimization of Senior Health (POSH) clinic, which
conducts preoperative comprehensive geriatric assessments (pCGA) at UW Health to understand
clinic processes and potential areas for improvement. The goal is to (1) create a process map
describing clinic workflow and (2) redesign the process with healthcare providers and
patients/families.
Description:
Aim 1: Process mapping using direct observation, interviews and focus groups to identify
opportunities for system redesign
The research team will directly observe n=30 patients in POSH clinic visits, taking notes and
documenting the persons, tasks, tools/technologies, environment and organizational factors
affecting healthcare delivery. Observer notes will be supplemented with audio recording of
the clinic visit. Observations will also include assessments performed by social workers,
pharmacist, medical assistants.
Semi-structured qualitative interviews with patients who participated in the observations and
their caregivers, if any, will be conducted 2 weeks after the pCGA visit. Interviewers will
assess barriers, facilitators, motivation, and adherence to tasks, and reflections on the
process of scheduling, attending and participating in the clinic. Surgeons who refer patients
(n=20) will be interviewed using semi-structured guides to elicit feedback on the process map
and explore perceived barriers and facilitators to adoption of the pCGA.
Focus Groups: Healthcare professionals and staff (n=20) who conduct the pcga will participate
in a focus group to provide feedback on the process map. The researchers will elicit feedback
on the process map, clarifying its accuracy as a representation of the tasks and procedures
performed, and identifying system-level barriers and facilitators at each step.
Aim 2: Co-design an implementation package for the pCGA at (2a) a large academic hospital and
(2b) an affiliate community site.
The research team will apply user-centered participatory design methods to adapt the process
map (aim 1) into an implementation package, which consists of a set of implementation
strategies, to address barriers and enhance facilitators at each step. Participatory design
(also called "co-design") is a systems engineering approach where the researchers and
participants work together in designing the workflow of an intervention. Co-design sessions
will be conducted in parallel at our University Hospital (2a) and a local affiliated
community hospital (2b). There will be two groups (design teams) of patients/caregivers and
healthcare professionals per location, for a total of four groups.
This study will include five co-design videoconference sessions with up to n=10 members in
each group (total n=40) over approximately 6 months, with 2-3 weeks between each session.
Each session will last 90 minutes. The sessions will identify process changes that can
address barriers and facilitators to promote implementation of the pCGA. The research team
will analyze audio recordings and notes from each session. These findings will be synthesized
and presented at the next design session. Each design team will participate in sessions
independently, however, the research team will summarize output from each session and provide
this content to the alternate design team for comment.
Design sessions are expected to generate an implementation package that is ready for
feasibility and pilot testing at the University hospital. Design sessions at the community
site will serve as a template for implementation at a future date.
