Implementation of ABI and WIfI in Rural Health Clinics

NCT04337723 | Completed

• 1 other identifier: 1374497
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Diabetic Foot; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ABI/WIFI adaption and fidelity

  6 months

• ABI/WIFI sustainability

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Misty D Humphries

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 8, 2020
• Study Start: March 10, 2020
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)