Implementation Pilot of Preoperative CGA Before Major Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient aged 80 or older who is scheduled for an elective inpatient major surgery
Providers working in a clinic (aged 18 and older) where pCGA is performed or a related anesthesia pre-operative clinic
Surgeons (adults older than 18) with a patient aged 80 or older who is scheduled for an elective inpatient major surgery
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Implementation Package for CGA
Other interventionThe Implementation Package will include streamlined referral processes and education for surgeons and staff about the new processes. These strategies will be applied after surgery is ordered to help increase the reach and adoption of the CGA.
Routine Clinical Care
Other interventionRoutine care may or may not include the use of the CGA before surgery. The use of CGA in clinical care is up to the medical and surgical healthcare providers.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Post ImplementationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of patients referred divided by number of eligible patients
Reach to potentially eligible patients will be measured by the number of patients referred divided by number of eligible patients.
Time frame
6 and 12 months after implementation2
Number of surgeons placing referral orders divided by the number of surgeons
Adoption by Referring Surgeons will be measured by the number of surgeons placing referral orders divided by the number of surgeons
Time frame
6 and 12 monthsSecondary outcomes
1
Fidelity: Percent of completed CGA components per visit
Fidelity of the intervention or degree to which the CGA is delivered as intended will be measured by the percent of completed CGA components per visit.
Time frame
30 days after visit2
Feasibility of Intervention Measure (FIM) Score
Perceived ease of use of implementation package will be measured by the 4-item validated Feasibility of Intervention Measure. Mean scores between 1 and 5 will be reported, where higher scores increased feasibility.
Time frame
6 and 12 months3
Acceptability of Intervention Measure (AIM) Score
Satisfaction with implementation package will be measured by the 4-item validated Acceptability of Intervention Measure. Mean scores between 1 and 5 will be reported, where higher scores increased acceptability.
Time frame
6 and 12 months4
Intervention Appropriateness Measure (IAM) Score
Fit and relevance of the implementation package will be measured by the 4-item validated Intervention Appropriateness Measure. Mean scores between 1 and 5 will be reported, where higher scores increased appropriateness.
Time frame
6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov