Fresh Food Farmacy: A Randomized Controlled Trial

Study Overview
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Brief Summary
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This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.

Detailed Description
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This is a pragmatic, prospective, randomized controlled trial of Geisinger's Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group). Approximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the Begin Now group. The control group will begin the program after 6 months: the Begin Later group. Approximately 2000 household members will be included in the data-only portion of the research. Outcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.

Official Title
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Fresh Food Farmacy: A Randomized Controlled Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Fresh Food Farmacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months Food insecure based on a two-question survey instrument Age > 17 & Age <86 Living within geographic reach of the program (Lewistown, PA and Scranton, PA) Exclusion Criteria: Already enrolled in FFF in Shamokin Not English speaking (working on changing this as the program evolves) On hospice or palliative care Acute or chronic psychosis Resides in a facility which provides meals Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including: Cancer; active treatment Steroid dependent asthma/ COPD/ emphysema Steroid dependent Colitis Chronic Kidney Disease with GFR< 30 mg/mmol Celiac disease Cirrhosis Steroid dependent arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group-Begin Now<br>Group 1- Will be randomized to the treatment (Begin Now) group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). | Other: Fresh Food Farmacy<br>* Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.<br>|
| No Intervention: Control Group-Begin Later<br>Group 2- Will be randomized to the control (Begin Later) group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c measures blood sugar control | Measured at 6 months after trial enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c measures blood sugar control over the prior three months | Measured at 12 months after trial enrollment for all subjects and at 3 months for those whose measurements are available. | 
| Fasting glucose | Fasting glucose measures blood sugar control over a shorter time horizon | 6 months and 12 months | 
| Weight | Weight in pounds | 6 months and 12 months | 
| Body Mass Index | Body Mass Index in kg/m^2 | 6 months and 12 months | 
| Total Cholesterol | Total Cholesterol | 6 months and 12 months | 
| LDL Cholesterol | LDL Cholesterol | 6 months and 12 months | 
| Blood pressure (systolic and diastolic) | Blood pressure | 6 months and 12 months | 
| Triglycerides | Triglycerides | 6 months and 12 months | 
| Patient survey questions on self-assessed health, wellbeing, attitudes toward healthy behavior, self-efficacy, and patient satisfaction | Survey questions for the research study will be examined individually and in groups of questions. | 6 months and 12 months | 
| Healthcare utilization | Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' electronic health record | 6 months and 12 months | 
| Healthcare utilization | Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' paid claims | 3 months, 6 months and 12 months | 
| Healthy behaviors observed in electronic health record | Healthy behaviors observed in electronic health record, including preventive care and appointments kept | 6 months and 12 months | 
| Healthy behaviors observed in paid claims HEDIS measures | HEDIS measures of preventive care | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes