Implementation of ABI and WIfI in Rural Health Clinics

Not Applicable

Completed

• Conditions: Diabetic Foot; Diabetes Mellitus; Peripheral Arterial Disease
• Interventions: Behavioral: ABI/WIFI scoring

• Registration Number: NCT04337723
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Primary Completion: 2022-02-28
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	ABI/WIFI scoring	Clinic participants will be taught how to do ABI testing and WIfI scoring to identify patients with PAD/DM disease for early vascular referral.

Primary Outcome Measures

Name	Time	Method
ABI/WIFI adoption	6 months	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

Secondary Outcome Measures

Name	Time	Method
ABI/WIFI adaption and fidelity	6 months	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.
ABI/WIFI sustainability	6 months	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.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States