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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Foot; Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: ABI/WIFI scoring

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Misty D Humphries, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Atherosclerosis; Foot Ulcer; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 1374497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No