Skip to content

Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments

Preparing Older Adults for Major Abdominal Surgery: a Systems Engineering Approach to Implement Preoperative Comprehensive Geriatric Assessments

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06184919
Enrollment
50
Registered
2023-12-29
Start date
2023-06-14
Completion date
2028-04-30
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Frailty, Health Care Utilization, Surgery

Keywords

Human Factors Engineering, Perioperative Optimization

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.

Interventions

OTHERProcess Mapping: Observations

Direct observations of the POSH clinic visit.

OTHERProcess Mapping: Interviews

Semi-structured interviews of patients and providers involved in the POSH clinic.

OTHERProcess Mapping: Focus Group

Focus group of providers and staff who conduct the POSH clinic.

OTHERParticipatory Design

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. There will be two groups (design teams) of patients/caregivers and healthcare professionals per location, for a total of four groups.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Process map12 monthsThe direct observations, interviews and focus groups conducted with patients and caregivers will help create a detailed process map of preoperative geriatric assessments. Specifically this map will detail the persons, tasks, tools/technologies, environment and organizational factors involved in the process according to the System Engineering Initiative for Patient Safety model.
Implementation Package24 monthsCo-design sessions will generate an implementation package, consisting of a set of implementation strategies, that can be piloted for its feasibility and adapted to facilitate preoperative comprehensive geriatric assessment in other settings.

Secondary

MeasureTime frameDescription
Qualitative data: Barriers and Facilitators to preoperative comprehensive geriatric assessments5 yearsThe qualitative analysis performed of interviews and focus groups during process mapping will identify barriers and facilitators to the use of preoperative comprehensive geriatric assessments.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJulia R Berian, MD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026