CARE-D-FOOT-Nav Pilot

Official title

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study

Overview

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.

Detailed description

The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a pilot trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. DFU healing rates remain low in the US. DFUs that fail to heal within 30 days are at a higher risk. Unfortunately, there is a resurgence in diabetes-related amputations. Healing requires complex, multidisciplinary care, focused on glycemic control, wound management, vascular disease treatment, and infection therapy. A strategy to facilitate multidisciplinary DFU care and support patients in their healing journey that can be widely implemented is essential to improve DFU healing rates and curb the diabetes-related limb loss pandemic, particularly for underserved and high-risk populations.

Patient navigators are healthcare personnel who mitigate barriers to care by facilitating care logistics, connecting patients to available resources, and promoting patient engagement. While navigators have been shown to improve diabetes outcomes, their effectiveness in improving DFU care and promoting healing remains untested. Informed by extensive preliminary data and community input, the investigators developed the CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program.

This study aims to determine whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively.

Interventions

• Other Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
  The 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

Primary outcome measures

• Proportion of the program components addressed [Time frame: Up to 20 weeks during program participation]
• Acceptability of the CARE-D-Foot-Nav intervention [Time frame: Up to 20 weeks during program participation]

Secondary outcome measures (12)

• Number of participants with wound healing with complete re-epithelialization of the wound. [Time frame: Baseline and week 20 (day 140 +/- 7 days)]
• Number of participants with confirmed wound healing [Time frame: Baseline and week 22]
• DFU care clinic attendance [Time frame: At 14 days and 30 days after hospital discharge]
• Wound area reduction [Time frame: Baseline and week 20]
• Major amputations [Time frame: After hospital discharge (up to 20 weeks)]
• Number of amputations [Time frame: After hospital discharge (up to 20 weeks)]
• Mortality [Time frame: After hospital discharge (up to 20 weeks)]
• Change in hemoglobin A1c [Time frame: Baseline and week 20]
• EuroQol five-dimensional (EQ-5D) score [Time frame: Baseline and week 20]
• Diabetic foot ulcer - short form (DFS-SF) score [Time frame: Baseline and week 20]
• Change in the Interpersonal Support Evaluation List-12 [Time frame: Baseline and week 20]
• Change in the Trust in Physicians' Scale [Time frame: Baseline and week 20]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Grady Memorial Hospital — Atlanta
• Emory University Hospital Midtown — Atlanta
• Emory University Hospital (EUH) — Atlanta
• Emory Decatur Hospital — Decatur

Identifiers

NCT: NCT07143175 · STUDY00008869

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗