Nutrition, Healthy Clinical Trial
Official title:
Impact of Proactive Outreach on Enrollment in and Utilization of the Flex Nutrition Program for Patients With Food Insecurity and Nutritionally Dependent Chronic Health Conditions
The goal of this clinical trial is to learn about the impact of proactive outreach on enrollment into and utilization of the Flexible Services Nutrition Program. The Flexible Services Nutrition Program increases access to healthy foods for patients with Medicaid ACO insurance, food insecurity and nutritionally dependent chronic health conditions. The main questions the study aims to answer are: - Does proactive outreach to eligible patients increase enrollment into the Medicaid ACO FLEX Nutrition Program, compared to usual care? - Does high intensity outreach (letter +phone calls) increase enrollment more than low intensity outreach (letter only)? The investigators will also conduct exploratory analyses to evaluate if proactive outreach has an effect on healthcare utilization (ED visits, unplanned hospitalizations, and outpatient no-show rate) and health outcomes (BMI for patients with overweight/obesity, a1c for patients with impaired fasting glucose/Diabetes, Blood Pressure for patients with Hypertension).
Status | Not yet recruiting |
Enrollment | 255 |
Est. completion date | February 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 64 Years |
Eligibility | Inclusion Criteria: Has Medicaid ACO as primary health insurance, confirmed food insecurity (defined as a positive screen on the Hunger Vital Sign, which is conducted in routine care within primary care) AND one of the following: 1. a Complex Physical Health Need 2. a Behavioral Health Need 3. a High Risk Pregnancy or 4. Repeated ED use. A Complex Physical Health Need is defined as having a diagnosis of one or more of the following: 1. Obesity (adults with BMI > 30, pediatrics with weight in 95-99 percentiles) 2. Diabetes 3. Hypertension 4. Chronic kidney disease or end stage renal disease 5. Chronic heart failure 6. Adult or pediatric cancer diagnosis 7. Malnutrition 8. Failure to thrive 9. Gastrointestinal disease (e.g. inflammatory bowel disease such as Crohn's or Ulcerative Colitis) 10. Asthma and two or more uncontrolled exacerbations per year 11. COPD and two or more exacerbations per year High cholesterol 12. HIV / AIDs 13. Vitamin D deficiency or receiving Vitamin D supplements A Behavioral Health Need is defined as one or more of the following: 1. Major depressive disorder 2. Generalized anxiety disorder 3. Bipolar disorder 4. Schizophrenia 5. Mood disorder (pediatric) 6. Developmental disorders (e.g. autism) 7. Substance use disorders or 8. (for adults) an individual with PHQ-9 score or GAD-7 score of 10 or greater. High Risk Pregnancy is defined as: High risk pregnant individual with a diagnosis of: 1. hypertensive disorders of pregnancy 2. pregestational or gestational diabetes 3. a referral to or care with a Maternal Fetal Medicine specialist or 4. other high-risk, high-acuity diagnoses that can benefit from meeting an unmet social need Repeated ED Use is defined as: 2+ ED visits in last 6 months or 4+ ED visits in last 12 months Exclusion Criteria: 1. Language other than English, Arabic, Spanish, or Creole. 2. Language unknown 3. Age> 64.5 years (patients age out of the Medicaid ACO at 65, and this is a 6 month intervention) 4. Previous referral (already in database whether or not enrolled) 5. Invalid address (e.g. exclude address="NPA") 6. No phone number 7. Same address as another patient in report (randomly select 1 to retain) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Referred to Flex Nutrition Program | The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO) | 3 months after outreach is completed | |
Primary | Enrollment into the Flex Nutrition Program | The percentage of patients in each study arm who are enrolled into the FLEX Nutrition program (Enrolled with the SSO). We will utilize SSO rosters of enrolled patients as our data source. | 3 months after outreach is completed | |
Primary | Enrollment in the Flex Nutrition Program by Vendor | For patients enrolled into Flex Nutrition, the percentage breakdown by SSO vendor
Community Servings Fresh Food Generation Fresh Connect We will utilize SSO rosters of enrolled patients as our data source. |
3 months after outreach is complete | |
Primary | Utilization of the Flex Nutrition Program | The percentage of patients in each study arm who used the FLEX Nutrition program at least once Numerator: patients with any positive utilization 3 mths after outreach is complete
Community Servings: received at least 1 delivery Fresh Food Generation: received at least delivery Fresh Connect: have charged their card at least once We will utilize SSO rosters of patients receiving services as our data source. |
3 months after outreach is complete | |
Secondary | Preventable ED visits | Number of ED visits that did not result in an admission 12 months pre-outreach compared to 12 months after outreach is completed | 12 months pre-outreach compared to 12 months after outreach is completed | |
Secondary | Avoidable Inpatient Hospitalizations | Unplanned inpatient hospitalizations 12 months pre-outreach compared to 12 months after outreach is completed | 12 months pre-outreach compared to 12 months after outreach is completed | |
Secondary | Outpatient no-show rate | No show rate during the 12 months pre-outreach period compared to 12 months after outreach is completed. | 12 months pre-outreach compared to 12 months after outreach is completed | |
Secondary | BMI for patients who are overweight/obese | Of patients with elevated BMI (defined as BMI>25 prior to outreach completed), change in pre-outreach BMI compared to 12 months after outreach is completed
BMI change for each patient: BMI pre-outreach (use last chronological value prior to outreach completed, within 12 months) - BMI 12 months after outreach is completed (If multiple values, use last chronological value post outreach, within 12 months) |
12 months pre-outreach compared to 12 months after outreach is completed | |
Secondary | A1c for patients with Impaired Fasting Glucose/Diabetes | Of patients with IFG/Diabetes (defined as Diagnosis of IFG/DM AND/OR a1c > 5.7 prior to outreach completed), change in pre-outreach a1c compared to 12 months after outreach is completed.
A1c change for each patient: a1c pre-outreach (If multiple values, use last chronological value prior to outreach completed, within 12 months) - a1c 12 months after outreach is completed (If multiple values, use last chronological value post outreach, within 12 months) |
12 months pre-outreach compared to 12 months after outreach is completed | |
Secondary | Blood Pressure for patients with HTN | Of patients with Hypertension (defined as Diagnosis of Hypertension AND/OR BP > 130/80 prior to outreach completed), change in pre-outreach Blood Pressure compared to 12 months after outreach is completed.
BP change for each patient: BP 12 mths pre-outreach (If multiple values, take mean of all values. If more than 1 value on one day, take the lowest value measured on that day) - BP during 12 months post-outreach period (If multiple values, take mean of all values. If more than 1 value on one day, take the lowest value measured on that day.) |
12 months pre-outreach compared to 12 months after outreach is completed |