Implementation of Telemedicine for Patient With Lower Extremity Wounds

Study Overview
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Brief Summary
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The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.

Detailed Description
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This is a clustered trial where patients identified as having lower extremity ulcers with peripheral artery disease and diabetes are given the option to be seen by specialty care providers through telemedicine vs. normal standard in person referral. The study is being conducted in rural areas where there are no in person vascular surgery providers. The aim of the study is to determine if patient activation affects likelihood to use telemedicine and if use of telemedicine can expedite speciality care.

Official Title
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Implementation of Telemedicine for Patient With Lower Extremity Wounds

Conditions
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Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Infection, Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: Telemedicine specialty consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with the diagnosis of a lower extremity ulcer that has been present for longer than 2 weeks Must be willing to complete the patient activation survey Must be willing to have the study personnel call them to check in on their status Exclusion Criteria: Patients that do not have a telephone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Telemedicine specialty consultation for patients | Other: Telemedicine specialty consultation<br>* Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine<br>|
| No Intervention: Standard Care<br>Standard in person referral to a specialist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specialty Consultation | The time from the date the wound is identified to the date of specialist consultation, in days. | up to 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revascularization | The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days. | up to 365 days | 
| Hospitalizations | Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals. | up to 365 days | 
| Emergency room visits | The number of emergency room visits for the wound or the index leg, from the time the wound was identified to the time the wound heals. | up to 365 days | 
| Wound healing | The time from when the wound is identified until the wound heals, in days. | up to 365 days | 
| Amputation | Major (above the ankle) or minor (toe/TMA) amputation of the index leg. | up to 365 days |