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Completed

NCT Number: NCT04337723

Implementation of ABI and WIfI 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABI/WIFI scoring

Behavioral

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.

Primary outcomes

  1. ABI/WIFI adoption

    Time frame: 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 outcomes

  1. ABI/WIFI adaption and fidelity

    Time frame: 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.

  2. ABI/WIFI sustainability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2020
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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