Implementation of ABI and WIfI in Rural Health Clinics
Primary Purpose
Peripheral Arterial Disease, Diabetic Foot, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABI/WIFI scoring
Sponsored by
About this trial
This is an interventional health services research trial for Peripheral Arterial Disease
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
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Clinic participants will be taught how to do ABI testing and WIfI scoring to identify patients with PAD/DM disease for early vascular referral.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04337723
First Posted
April 1, 2020
Last Updated
April 24, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04337723
Brief Title
Implementation of ABI and WIfI in Rural Health Clinics
Official Title
Implementation of Ankle Brachial Index Measurements and Wound, Ischemia, and Foot Infection Testing in Rural Health Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Diabetic Foot, Diabetes Mellitus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinic participants will be taught how to do ABI testing and WIfI scoring to identify patients with PAD/DM disease for early vascular referral.
Intervention Type
Behavioral
Intervention Name(s)
ABI/WIFI scoring
Intervention Description
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 Outcome Measure Information:
Title
ABI/WIFI adoption
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ABI/WIFI adaption and fidelity
Description
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.
Time Frame
6 months
Title
ABI/WIFI sustainability
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misty D Humphries
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Implementation of ABI and WIfI in Rural Health Clinics
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