SurgeryNCT06184919
Preparing Older Adults for Major Surgery With Preoperative Comprehensive Geriatric Assessments
An observational study of Surgery and Aging, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Aging, Health Care Utilization
- What is being tested?
- Process Mapping: Observations, Process Mapping: Interviews and Process Mapping: Focus Group
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Observations and Interviews in the Perioperative Optimization of Senior Health (POSH) clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Process Mapping: Observations, Process Mapping: Interviews, Process Mapping: Focus Group, Participatory Design
- Keywords
- Human Factors Engineering, Perioperative Optimization
- Medical subject headings
- Patient Acceptance of Health Care, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process Mapping: ObservationsOther
Direct observations of the POSH clinic visit.
Process Mapping: InterviewsOther
Semi-structured interviews of patients and providers involved in the POSH clinic.
Process Mapping: Focus GroupOther
Focus group of providers and staff who conduct the POSH clinic.
Participatory DesignOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients and caregivers | Patients attending the Perioperative Optimization of Senior Health (POSH) clinic Receives: Other: Process Mapping: Observations; Other: Process Mapping: Interviews; Other: Participatory Design | |
| Healthcare providers | Healthcare providers referring to or working in the Perioperative Optimization of Senior Health (POSH) clinic Receives: Other: Process Mapping: Observations; Other: Process Mapping: Interviews; Other: Process Mapping: Focus Group; Other: Participatory Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start14 Jun 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Julia R Berian, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184919
- Sponsor's protocol ID
- 2022-1516
- Other IDs
- A539707, SMPH/SURGERY/COLON RECT, 1K23AG081487-01, 2024-0044 [Aim 2]
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Older Adults for Major Abdominal Surgery: a Systems Engineering Approach to Implement Preoperative Comprehensive Geriatric Assessments
- ClinicalTrials.gov ID
- NCT06184919
- Acronym / sponsor ID
- 2022-1516
- Conditions
- Surgery, Aging, Health Care Utilization, Frailty
- Keywords
- Human Factors Engineering, Perioperative Optimization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients and caregivers | – | Other: Process Mapping: Observations, Other: Process Mapping: Interviews, Other: Participatory DesignPatients attending the Perioperative Optimization of Senior Health (POSH) clinic |
| Healthcare providers | – | Other: Process Mapping: Observations, Other: Process Mapping: Interviews, Other: Process Mapping: Focus Group, Other: Participatory DesignHealthcare providers referring to or working in the Perioperative Optimization of Senior Health (POSH) clinic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Observations and Interviews in the Perioperative Optimization of Senior Health (POSH) clinic.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- For patients:
- For pCGA clinicians and staff: none
- For surgeons: none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Process Mapping: ObservationsDirect observations of the POSH clinic visit. | Other | Healthcare providers, Patients and caregivers |
| Process Mapping: InterviewsSemi-structured interviews of patients and providers involved in the POSH clinic. | Other | Healthcare providers, Patients and caregivers |
| Process Mapping: Focus GroupFocus group of providers and staff who conduct the POSH clinic. | Other | Healthcare providers |
| Participatory DesignParticipatory 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 | Healthcare providers, Patients and caregivers |
Primary outcome
Process map
Time frame: 12 months
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.
Implementation Package
Time frame: 24 months
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.
1 secondary outcome
Qualitative data: Barriers and Facilitators to preoperative comprehensive geriatric assessments
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Implementation Pilot of Preoperative CGA Before Major SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia R Berian, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Aging, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process map (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.