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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Frailty; Aging; Surgery; Health Care Utilization
• Intervention / Treatment: Other: Process Mapping: Observations; Other: Process Mapping: Interviews; Other: Participatory Design; Other: Process Mapping: Focus Group

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.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Observations and Interviews in the Perioperative Optimization of Senior Health (POSH) clinic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients and caregivers; Patients attending the Perioperative Optimization of Senior Health (POSH) clinic	Other: Process Mapping: Observations; Direct observations of the POSH clinic visit.; Other: Process Mapping: Interviews; Semi-structured interviews of patients and providers involved in the POSH clinic.; 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.
Healthcare providers; Healthcare providers referring to or working in the Perioperative Optimization of Senior Health (POSH) clinic	Other: Process Mapping: Observations; Direct observations of the POSH clinic visit.; Other: Process Mapping: Interviews; Semi-structured interviews of patients and providers involved in the POSH clinic.; 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.; Other: Process Mapping: Focus Group; Focus group of providers and staff who conduct the POSH clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process map	The 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.	12 months
Implementation Package	Co-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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative data: Barriers and Facilitators to preoperative comprehensive geriatric assessments	The qualitative analysis performed of interviews and focus groups during process mapping will identify barriers and facilitators to the use of preoperative comprehensive geriatric assessments.	5 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Julia R Berian, MD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• Implementation Pilot of Preoperative CGA Before Major Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Human Factors Engineering; Perioperative Optimization
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2022-1516; A539707 (Other Identifier: UW Madison); SMPH/SURGERY/COLON RECT (Other Identifier: UW Madison); 1K23AG081487-01 (U.S. NIH Grant/Contract); 2024-0044 [Aim 2] (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No