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Clinical Trials/NCT04337723
NCT04337723CompletedNot Applicable

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

University of California, Davis2 sites in 1 country135 target enrollmentStarted: March 10, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
135
Locations
2
Primary Endpoint
ABI/WIFI adoption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • ABI/WIFI adaption and fidelity(6 months)
  • ABI/WIFI sustainability(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Misty Humphries

Associate Professor of Surgery

University of California, Davis

Study Sites (2)

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