Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound

Pictures will be taken at baseline and week 20 and compared by two different reviewers. The number of participants with complete wound healing will be reported.

Baseline, Week 20 (day 140 +/- 7 days)

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.

Baseline, week 22

DFU care clinic attendance

This will be defined as attending outpatient visits with any provider managing a) diabetes b) wound care c) antibiotic for DFU infection, if applicable, and (d) obtaining non-invasive PAD testing if not done in the last 12 months.

Within 14 and 30 days post hospital discharge

Wound area reduction

Difference in diabetic foot ulcer area will be reported

Baseline, Week 20

Major amputation

Number of subjects undergoing amputation above the ankle.

Baseline, Week 20

Number of deaths

Number of deaths during the study period.

Baseline, Week 20

EuroQol five-dimensional (EQ-5D) score

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.

Baseline, Week 20

Glycemic control: Change in HbA1c

Change in hemoglobin A1c will be reported.

Baseline, Week 20

Perceived social support: 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 and evaluates 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.

Baseline, Week 20

Medical mistrust: Change in 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.

Baseline, Week 20

Tobacco cessation

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

Baseline, Week 20

Acute care utilization

All-cause emergency department (ED) visits and re-hospitalizations

After hospital discharge (up to 20 weeks)

Services accessed

Services accessed between baseline and week 20 (e.g., foodbank) ascertained through electronic medical record review and participant interviews

Baseline, Week 20

Peer support group attendance

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

Baseline, Week 20

Diabetic foot ulcer - short form (DFS-SF) score

A short form of the Diabetic Foot Ulcer Scale (DFS), which 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.

Baseline, 20 weeks

Patient Health Questionnaire-2 (PHQ-2)

The PHQ-2 is a two-question screening for depression that asks about the frequency of a depressed mood and lack of pleasure in activities over the past two weeks. Scores range from 0 to 6, with a score of 3 or higher indicating a positive screen that warrants further assessment, typically with the full PHQ-9, to confirm a diagnosis and gauge severity.

Baseline, 20 weeks

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 is a screening tool for depression that uses nine questions answered on a 0-3 scale (not at all, several days, more than half the days, nearly every day), with the total score ranging from 0 to 27. A professional assesses the total score to gauge depression severity: 0-4 (minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20+ (severe).

Baseline, 20 weeks

Food insecurity

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

Baseline, Week 20

Housing stability

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.

Baseline, Week 20

Financial resource strain questionnaire

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.

Baseline, Week 20

Transportation needs

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.

Baseline, Week 20