Clinical trial NCT05972421: Enrollment in and Utilization of the Flex Nutrition Program
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Food Insecurity
Vulnerable Populations
Nutrition, Healthy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 255
Sex: ALL
Minimum age (years): 3
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: The Medicaid ACO Flexible Services Program is a pilot that allocates state funding to address certain health-related social needs, in the domains of food and housing, with the goal of improving health outcomes and reducing the total cost of health care for members. The Flex Nutrition Program specifically allows members with a health needs-based criteria (such as a complex physical health need, repeated Emergency Department use or a high-risk pregnancy) who are experiencing food insecurity (defined as a positive screening on the Hunger Vital Sign questionnaire) to receive nutritional support.

At MGH, the investigators have partnered with 3 Social Service Organizations (SSOs) to deliver 3 types of nutritional support. Community Servings provides medically tailored meals with nutritional counseling. Fresh Food Generation provides healthy food boxes. Fresh Connect provides debit cards with monthly allotments that can be used to purchase produce.

The current workflow for identifying and enrolling appropriate ACO members relies largely on referrals from Primary Care Teams. Role groups who respond to social needs within primary care, such as Community Health Workers, integrated Care Managers, Community Resource Navigators and Emergency Department Navigators (collectively herein referred to as Care Managers), have been trained on the program's eligibility requirements and encouraged to offer enrollment to the patients they are working with. However, this current method in inadequate to identify many eligible patients. Only a very small subset of patients (less than 10%) with social needs identified on their primary care screening questionnaire are referred to Care Managers. In addition, Care Managers do not have any consistent method for identifying patients and offering the Flex Nutrition Program.

For patients interested in enrollment, Care Managers refer to two dedicated FLEX staff. Upon receipt of a referral, these two staff complete a Verification, Planning and Referral (VPR) form in EPIC, which generates a referral for the appropriate SSO, who subsequently reaches out to enroll the patient.

The investigators seek to understand if proactive outreach to eligible patients increases enrollment into and utilization of the Medicaid ACO Flex Nutrition Program. To answer this question, the investigators will identify eligible members (patients in the Medicaid ACO with a positive food insecurity screening plus one or more defined health conditions, see Inclusion criteria for more details) via an EPIC Report and randomize them into 3 cohorts. Cohort A will receive high intensity proactive outreach via phone, Cohort B will receive low-intensity outreach via letter and Cohort C will receive usual care with no proactive outreach. The investigators will use an EPIC report to generate a list of eligible patients, defined as Adult and Pediatric patients cared for within MGH Primary Care in the Medicaid ACO with a health needs-based criteria and a positive screening for food insecurity. Patients already enrolled into the Flex Nutrition program will be excluded.

The rationale for randomization is that our 2 FLEX staff have limited bandwidth to proactively outreach to all eligible patients. Randomizing eligible patients will ensure their efforts are distributed fairly and also allow the investigators to evaluate the effectiveness of low intensity and high intensity outreach. The Flex Services Nutrition Program is incorporated into routine clinical care at MGH.

Eligibility criteria: 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)

Primary outcomes:
measure: Referred to Flex Nutrition Program
timeFrame: 3 months after outreach is completed
measure: Enrollment into the Flex Nutrition Program
timeFrame: 3 months after outreach is completed
measure: Enrollment in the Flex Nutrition Program by Vendor
timeFrame: 3 months after outreach is complete
measure: Utilization of the Flex Nutrition Program
timeFrame: 3 months after outreach is complete
Secondary outcomes:
measure: Preventable ED visits
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
measure: Avoidable Inpatient Hospitalizations
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
measure: Outpatient no-show rate
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
measure: BMI for patients who are overweight/obese
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
measure: A1c for patients with Impaired Fasting Glucose/Diabetes
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
measure: Blood Pressure for patients with HTN
timeFrame: 12 months pre-outreach compared to 12 months after outreach is completed
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Sarah Matathia, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: