CARE-D-FOOT-Nav Pilot
ConditionDiabetic Foot Ulcer (DFU)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).
Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise.
Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed.
This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations)
English-speaking patients (available patient navigators are English-speaking).
Disqualifiers
Patients who are unable to understand the nature and scope of the study,
Enrolled in another clinical trial,
Planned discharge to an acute or long-term care facility,
Planning to receive outpatient DFU care outside of Grady.
Trial design
Design model
Single group
Treatments tested in this trial
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
Other interventionThe CARE-D-FOOT-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program is a patient navigator intervention that aims to increase access to guideline-concordant multidisciplinary DFU care to improve DFU healing. CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator. The navigator will assist the subjects with diabetic foot ulcer care. Based on community input, navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Additional contact may be warranted to coordinate appointments and transportation. Participants can call the navigator with DFU-related concerns at any time during the navigator's working hours. The overarching goal of the navigator is to help patients access the four key pillars of DFU care, thereby optimizing the chances of DFU healing.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of the program components addressed
Researchers will measure the program fidelity by the proportion of the program components addressed by the navigators. Navigators will address 16 components during the weekly encounters and 22 components at every fourth encounter. Researchers will record all encounters and will listen to the recordings of encounters and count which components were or were not discussed (binary outcome, yes/no), and measure consistency across navigators.
Time frame
Up to 20 weeks during program participation2
Acceptability of the CARE-D-Foot-Nav intervention
Researchers will conduct focus group discussions and/or one-on-one interviews with the participants to understand the program's likes and dislikes. There is no measuring scale.
Time frame
Up to 20 weeks during program participationSecondary outcomes
1
Number of participants with wound healing with complete re-epithelialization of the wound.
Researchers will measure the effectiveness of the intervention by the wound healing. Researchers will take pictures of the wounds at enrollment and week 20 (day 140 +/- 7 days), and two independent reviewers who are clinical DFU experts, will review the pictures to ascertain wound healing. To minimize the missing data, participants who miss the final 20-week visit will be asked to send pictures of their feet. If \>1 DFU is present, wound healing assessment will be based on the largest wound. If participants experience amputation or death before week 20, the ulcer will be classified as not healed.
Time frame
Baseline and week 20 (day 140 +/- 7 days)2
Number of participants with confirmed wound healing
Researchers will measure the effectiveness of the intervention based on wound healing. Photographs of the wounds will be taken at enrollment and again at week 22 (i.e., approximately two weeks ±7 days after the participant's primary outcome visit). Two independent reviewers, who are clinical DFU experts, will evaluate the photographs to determine whether wound healing has occurred. If more than one DFU is present, the assessment will be based on the largest wound. If a participant undergoes an amputation or dies before week 20, the ulcer will be classified as not healed.
Time frame
Baseline and week 223
DFU care clinic attendance
DFU care clinic attendance within 14- and 30-days of hospital discharge, defined as attending outpatient visits with any provider managing a) diabetes, b) wound care, c) antibiotics for DFU infection, if applicable, and (d) obtaining non-invasive PAD testing if not done in the last 12 months. Researchers will measure these outcomes singly and in combination.
Time frame
At 14 days and 30 days after hospital discharge4
Wound area reduction
Difference in diabetic foot ulcer areas will be reported.
Time frame
Baseline and week 20Other outcomes
1
Costs and resource utilization
Total resource utilization cost per participant over the study period will be calculated by converting the following components to standardized U.S. dollar equivalents and summing time navigators spend with participants and coordinating care, time providers spend discussing participant care with navigators, number of outpatient visits scheduled by navigators, and the cost of wound care supplies, phones dispensed, and transportation.
Time frame
After hospital discharge (up to 20 weeks)Sponsors and contacts
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Source ClinicalTrials.gov