Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments

NCT ID: NCT06184919

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2028-04-30

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.

Conditions

Surgery; Aging; Health Care Utilization; Frailty

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients and caregivers

Patients attending the Perioperative Optimization of Senior Health (POSH) clinic

Process Mapping: Observations

Intervention Type: OTHER

Direct observations of the POSH clinic visit.

Process Mapping: Interviews

Intervention Type: OTHER

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

Participatory Design

Intervention Type: OTHER

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.

Healthcare providers

Healthcare providers referring to or working in the Perioperative Optimization of Senior Health (POSH) clinic

Process Mapping: Observations

Intervention Type: OTHER

Direct observations of the POSH clinic visit.

Process Mapping: Interviews

Intervention Type: OTHER

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

Process Mapping: Focus Group

Intervention Type: OTHER

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

Participatory Design

Intervention Type: OTHER

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.

Interventions

Process Mapping: Observations

Direct observations of the POSH clinic visit.

Intervention Type: OTHER

Process Mapping: Interviews

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

Intervention Type: OTHER

Process Mapping: Focus Group

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

Intervention Type: OTHER

Participatory 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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia R Berian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Related Links

https://clinicaltrials.gov/study/NCT06184724

Implementation Pilot of Preoperative CGA Before Major Surgery

Other Identifiers

A539707

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY/COLON RECT

Identifier Type: OTHER

Identifier Source: secondary_id

1K23AG081487-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0044 [Aim 2]

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1516

Identifier Type: -

Identifier Source: org_study_id