Geriatric Assessment, Health Services Research, Implementation Science, Surgery
Conditions
Brief summary
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.
Detailed description
The goal of this clinical trial is to test a new implementation package, which will be applied at the system-level, to see whether it can help more older adults prepare for major surgery. The study will evaluate whether the implementation package (1) improves the number of older adults who get a full "comprehensive geriatric assessment" (CGA) before surgery compared to the number of older adults who would be eligible for it, also called "reach"; and (2) increases the use of CGA by the medical and surgical providers who are taking care of these older adults, also called "adoption". Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The implementation package will include streamlined referral processes and education for surgeons and staff about the new processes. The results will be compared to a historic baseline Findings from this study will help the lead researcher design a larger trial that will test both the implementation (or how something is done) at the same time as it tests the effectiveness (how well it works).
Interventions
OTHERImplementation Package for CGA
The 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 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.
Sponsors
University of Wisconsin, Madison
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants will be recruited from surgery clinics in a pre-post trial. The comparison group is a historic baseline for routine care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient aged 80 or older who is scheduled for an elective inpatient major surgery 2. Providers working in a clinic (aged 18 and older) where pCGA is performed or a related anesthesia pre-operative clinic 3. Surgeons (adults older than 18) with a patient aged 80 or older who is scheduled for an elective inpatient major surgery
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients referred divided by number of eligible patients | 6 and 12 months after implementation | Reach to potentially eligible patients will be measured by the number of patients referred divided by number of eligible patients. |
| Number of surgeons placing referral orders divided by the number of surgeons | 6 and 12 months | Adoption by Referring Surgeons will be measured by the number of surgeons placing referral orders divided by the number of surgeons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity: Percent of completed CGA components per visit | 30 days after 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. |
| Feasibility of Intervention Measure (FIM) Score | 6 and 12 months | 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. |
| Acceptability of Intervention Measure (AIM) Score | 6 and 12 months | 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. |
| Intervention Appropriateness Measure (IAM) Score | 6 and 12 months | 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. |
Countries
United States
Contacts
CONTACTJulia R Berian, MD, MS
PRINCIPAL_INVESTIGATORJulia R Berian, MD, MS
University of Wisconsin, Madison
Outcome results
None listed