Mutton Heart Failure Food is Medicine Pilot

Proportions of meals that were successfully picked up or received by the patient. We have determined that >70% would count as success/feasibility of the intervention.

The Cultural Connectedness Scale (CCS) was developed in Canada by First Nations/Indigenous persons for First Nations/Indigenous persons. The 29-item CCS consists of three sub-scales: identity, traditions, and spirituality. This scale ranges from 0-40, with 40 indicating higher levels of cultural connectiveness.

This is a validated score for evaluating quality of life and symptom measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.

The six-item short form of the survey module and the associated Six-Item Food Security Scale were developed by researchers at the National Center for Health Statistics in collaboration with Abt Associates Inc.

Hospitalization or Visit to Emergency Department (All-cause)

Albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP

weight and BMI

ER visits: All cause

All cause

ER visit for volume overload or HF symptoms

Hospitalizations for heart failure specifically

Proportions of meals that were successfully delivered to the Gallup Food Pantry by our community partner and Native-run Kitchen

We will survey patients post-intervention with question to assess feasibility: "I would rate getting the meals (either picking up or delivery): Very easy, Somewhat easy, Neither easy nor difficult, Somewhat difficult, Very difficult.

We will evaluate acceptability of the intervention among the patients through quantitative assessment using the validated acceptability of the intervention (AIM) measure

We will also assess acceptability of the intervention through assess the Net Promoter Score (i.e. how likely is it that you would recommend this program to a community member?"), which is a scale 1 (highly unlikely) to 10 (highly likely).

Patients will also rate meals from 1-5 and the amount of the meal they consumed (none [or only a few bites], less than half, about half, most, or all)

Patients will also be surveyed post-intervention the following questions to assess acceptability: How would you rate the meals overall, in terms of taste (excellent, good, average, below average, bad?"

We will also perform semi-structured interviews of patients to assess feasibility and acceptability through qualitative methods. Semi-structured interviews will be guided by the Consolidated Framework for Implementation Research (CFIR), and we will explore multiple constructs within each CFIR domain that are hypothesized by the study team and based on existing literature to be relevant to acceptability and feasibility of the program

We will assess feasibility among our community partners by assessing the validated feasibility of the intervention measure (FIM) among our food pantry partners.

We will also assess the % of meals that include locally sourced ingredients, % of meals sourced by Native suppliers/farmers (produce), % of meals soured by Native ranchers (meat)

We will determine the proportion of patients that completes baseline, as well as post-implementation survey and laboratory data.

We will consider ≥ 80% completion rates as a success.

We will assess fidelity of the intervention by evaluating:

• We will have patients' complete food diaries for 3 days during week 1 and week 4 of the intervention.
• % of meals consumed: Patients will also fill out meal cards weekly with percent consumed (None [or a few bites], ¼, ½, ¾, all [or nearly all]).

§ We will stratify meals consumed by whether the meal used traditional Diné ingredients or not.

• We will additionally survey participants post-intervention the following:

• In terms of leftovers, how much of the meals were not eaten and had to be thrown out? (all, most, about half, less than half, none).

• We will consider ≥ 70% meals consumed (at least ½ or more of the meal) or ≥70% indicating they ate "most" or more of the meals as a success

We will survey participants post-intervention the following using a Likert scale:

• How likely is it that this program will change your diet to be healthier moving forward? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely)
• How likely is it that you will add any of the meals or recipes from this program to your on-going diet in the future? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely)

We will assess diet quality using the 10-item DSQ [10] with an addition question to assess traditional Dine food intake (During the past month, how often did you eat traditional Diné foods (such as blue corn mush, steamed, roasted or dried corn, sumac berries, mutton, local varieties of squash or beans) at baseline and at the end of the intervention.

We will evaluate how much physical activity/exercise patients are participating in weekly at baseline, and at 30 days by asking patients to estimate the number of minutes weekly that they are participating in formal exercise or physical activity.

We will evaluate patients' general health status using a single general health status question (would you say that in general your health is excellent, very good, good, fair, or poor) at baseline and post-intervention

Subsection of KCCQ-12 Summary

Subsection of KCCQ12 looking at physical limitation

Subsection of KCCQ-12 looking at frequency of symptoms

Subsection of KCCQ-12 that looks at quality of life

Subsection of KCCQ-12 looking at social limitation

Additional exploratory outcomes will prescription rates for all medication as well as guideline-directed medical therapy specifically (for heart failure with reduced ejection fraction this would include ACEi/ARB/ARNI, Beta-blocker, SGLT2 inhibitors, and mineralocorticoid receptor antagonist; for HFpEF this would include SGLT2 inhibitors).