Clinical trial NCT06184919: Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments
Official title: Preparing Older Adults for Major Abdominal Surgery: a Systems Engineering Approach to Implement Preoperative Comprehensive Geriatric Assessments
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Surgery
Aging
Health Care Utilization
Frailty
Keywords: Human Factors Engineering
Perioperative Optimization
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-29
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observations and Interviews in the Perioperative Optimization of Senior Health (POSH) clinic.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being a patient seen for a pCGA clinic at the time of observations, or being the caregiver of such a patient.
* Being a clinician or staff member working at the pCGA clinic
* Being a surgeon who frequently refers patients to the pCGA clinic

Exclusion Criteria:

* For patients:

  * not being fluent in English
  * having an enacted power of attorney indicating that the patient is unable to make medical decisions for themselves and a legally authorized representative (LAR) does not attend the pCGA visit with the patient
* For pCGA clinicians and staff: none
* For surgeons: none

Primary outcomes:
measure: Process map
timeFrame: 12 months
measure: Implementation Package
timeFrame: 24 months
Secondary outcomes:
measure: Qualitative data: Barriers and Facilitators to preoperative comprehensive geriatric assessments
timeFrame: 5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Julia R Berian, MD
role: PRINCIPAL_INVESTIGATOR
References: