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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04337723
Other study ID # 1374497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2020
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date December 31, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of California Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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