Enrollment in and Utilization of the Flex Nutrition Program

NCT ID: NCT05972421

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-02-01

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.

Conditions

Food Insecurity; Vulnerable Populations; Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

High Intensity Proactive Outreach

Patients will receive a mailed letter as well as proactive outreach by phone. The objective of the letter and phone outreach is to describe the Flex Nutrition Program and offer enrollment.

Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed.

1 week following the mailing of the letter, patients will receive 3 phone calls within 10 business days, occurring at different times of day. Patients will be provided a call back number. Phone calls will be made to patients in their primary languages, with the use of Interpreters as needed.

Group Type: EXPERIMENTAL

High Intensity Proactive Outreach

Intervention Type: OTHER

phone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program

Low Intensity Proactive Outreach

Patients will receive a mailed letter. The objective of the letter is to describe the Flex Nutrition Program and offer enrollment.

Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed.

Group Type: EXPERIMENTAL

Low Intensity Proactive Outreach

Intervention Type: OTHER

mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program

No Outreach; Usual Care

Patients will not receive any proactive outreach and will serve as a comparison group. These patients may be referred to the Flex Nutrition Program through their Care Managers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High Intensity Proactive Outreach

phone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program

Intervention Type: OTHER

Low Intensity Proactive Outreach

mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program

Intervention Type: OTHER

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sarah A. Matathia, MD, MPH

Associate Medical Director of Primary Care Equity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Matathia, MD MPH

Role: PRINCIPAL_INVESTIGATOR

MGH

Central Contacts

Saja Alani, MPH

Role: CONTACT

salani@mgh.harvard.edu

617-726-1369

Suzanne Brodney, PHD

Role: CONTACT

SBRODNEY@mgh.harvard.edu

617-643-4226

Other Identifiers

2022P002954

Identifier Type: -

Identifier Source: org_study_id