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Implementation of ABI and WIfI in Rural Health Clinics

Implementation of Ankle Brachial Index Measurements and Wound, Ischemia, and Foot Infection Testing in Rural Health Clinics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04337723
Enrollment
135
Registered
2020-04-08
Start date
2020-03-10
Completion date
2022-12-31
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Foot, Peripheral Arterial Disease

Brief summary

The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for new patients with lower extremity ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at RHCs in the telemedicine network through a rural provider education program that is aligned with preexisting continuing medical education activities.

Interventions

BEHAVIORALABI/WIFI scoring

The initial ABI training workshop will be coordinated by the non-physician clinic staff champion, and all non-provider clinic staff will be asked to participate. The PI and a research assistant will conduct a 1.5-hour telemedicine training session instructing clinical staff in ABI measurement and WIfI and scoring, using the clinical scoring sheet. Following didactic teaching, participants will perform ABI tests under the guidance of the PI/research assistant and with the support of other participants. During each part of the workshop, specific attention will be directed to pitfalls and technical errors of the test. A pre-post assessment will be used to ensure comprehension of key concepts and performance of the ABI and WIfI tools.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

To be eligible for the educational program, an RHC must: * already have telemedicine capabilities with the UC Davis CHT, * be within 3 hours driving time form UC Davis Medical Center, * have a lead practitioner willing to act as the clinic's point person for the proposed educational project, and * have seen at least 10 patients in the prior 3 months with foot ulcers due to DM, PAD or combined disease.

Exclusion criteria

To be eligible for the project, a RHC must NOT: * have a dedicated foot ulcer assessment program with on-site measurement of arterial perfusion, and * be located within a 45 minute drive of a vascular surgeon

Design outcomes

Primary

MeasureTime frameDescription
ABI/WIFI adoption6 monthsThis outcome is a binary (yes/no) outcome of whether a clinic is performing ABI and WIfI testing 6 months after the original training and implementation assistance

Secondary

MeasureTime frameDescription
ABI/WIFI adaption and fidelity6 monthsThis outcome is a qualitative outcome. The outcome is based on the use a modified Program Assessment Fidelity Tool developed by Cummins. This tool tracks programmatic and evaluative changes over time. The tool asks respondents to determine the What, How, To Whom, Where, and Who program changes occur with definitions for each category. The tool classifies changes by cause.
ABI/WIFI sustainability6 monthsTo assess sustainability, we will collect the number of patients seen with lower extremity ulcers over a one-year period and the number of patients with ABI measurement performed. We will review charts for the number of patients with WIfI classification documentation at the clinical encounter.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026