Implementation of ABI and WIfI in Rural Health Clinics

NCT ID: NCT04337723

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ABI/WIFI scoring

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Misty Humphries

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Misty D Humphries

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

1374497

Identifier Type: -

Identifier Source: org_study_id