CARE-D-FOOT-Nav Pilot

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.

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.

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.

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.

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.

Difference in diabetic foot ulcer areas will be reported.

Number of subjects undergoing amputation above the ankle.

Number of subjects undergoing any type of amputation (major or minor) after hospital discharge.

Number of deaths after hospital discharge during the study period.

Researchers will measure glycemic control by the change in hemoglobin A1c.

The EuroQol 5-Dimension (EQ-5D) is a standardized instrument used to measure health-related quality of life. It's a self-report questionnaire that assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a few levels of severity, allowing individuals to describe their health state. Each dimension has five levels: 1 = no problems, to 5 = extreme problems/unable to do. The five answers produce a unique 5-digit health state, for example, 11234, that describes the young person's health state. For example, the code 11234 describes a health state where there are no problems with walking about (mobility) or looking after myself, a little bit of a problem with doing usual activities, some pain or discomfort, and feeling really worried, sad, or unhappy.

A short form of the Diabetic Foot Ulcer Scale (DFS) is called the Diabetic Foot Ulcer Scale-Short Form (DFS-SF). It's a 29-item questionnaire designed to assess the impact of diabetic foot ulcers on a patient's quality of life (QOL), grouped into six subscales: leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, and bothered by ulcer care. Each item is scored on a 5-point Likert scale, ranging from 1 = "not at all" to 5 = "very common". Each subscale is scored on a scale of 0 to 100. Higher scores on the DFS-SF indicate a better quality of life, while lower scores indicate a poorer quality of life.

The minimum score for each subscale is 0, representing the worst QOL, and the maximum score is 100, representing the best QOL.

Perceived social support will be measured using the Interpersonal Support Evaluation List-12. The Interpersonal Support Evaluation List-12 (ISEL-12) is a brief, validated questionnaire designed to assess perceived availability of social support. The ISEL-12 includes 12 items that evaluate the perceived support across three dimensions: Appraisal Support, Belonging Support, and Tangible Support.

Each item is rated on a 4-point Likert scale. Scores range from 12 to 48, with higher scores indicating greater perceived social support and low scores indicating lower social support.

Medical mistrust will be measured using the Trust in Physicians Scale. Trust in Physicians Scale is used to measure interpersonal trust a patient has in their individual physician.

Each item is rated on a 5-point Likert scale. Total score range: 11 (low trust) to 55 (high trust).

Higher scores indicate greater trust in the physician.

Self-reported cessation at week 20 among those reporting tobacco use at baseline.

All-cause emergency department (ED) visits and re-hospitalizations after hospital discharge.

Services accessed (e.g., foodbank) after hospital discharge ascertained through electronic medical record review and participant interviews.

Food insecurity will be assessed via validated EHR-embedded survey items. Food insecurity severity is often assessed based on the number of affirmative responses. More affirmative responses typically indicate greater food insecurity.

Housing Stability will be assessed using survey items embedded in the electronic health record (EHR). Responses are coded as:

0 = Stable housing (e.g., own/rent a steady place to live)

1 = Unstable housing (e.g., temporarily staying with others, in a shelter, or without a place to live)

Scores will be summarized as the proportion of participants with unstable housing at baseline and week 20.

Financial resource strain scoring assesses the level of difficulty individuals experience in meeting their basic living expenses and financial obligations, assessed via validated EHR-embedded survey items. A score of 27 on the Financial Strain Questionnaire indicates greater financial strain than a score of 9. Lower scores/categories indicate less financial strain. Higher scores indicate greater strain

Transportation needs will be assessed via a validated EHR-embedded transportation survey from the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) tool.

The transportation tool is a 2-question survey where "yes" indicates transportation needs. More affirmative responses typically indicate increased transportation needs.

Proportion of CARE-D-Foot-Nav participants who attended ≥1 peer support group meetings and number of meetings attended.

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.