Implementation of ABI and WIfI in Rural Health Clinics

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337723
• Other study ID #: 1374497
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• ABI/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.

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABI/WIFI adoption	This 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	6 months
Secondary	ABI/WIFI adaption and fidelity	This 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.	6 months
Secondary	ABI/WIFI sustainability	To 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.	6 months