Enrollment in and Utilization of the Flex Nutrition Program

NCT05972421 | Unknown

• 1 other identifier: 2022P002954
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Food Insecurity; Vulnerable Populations; Nutrition, Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Enrollment in the Flex Nutrition Program by Vendor

  For patients enrolled into Flex Nutrition, the percentage breakdown by SSO vendor 1. Community Servings 2. Fresh Food Generation 3. Fresh Connect We will utilize SSO rosters of enrolled patients as our data source.

  3 months after outreach is complete

• 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 1. Community Servings: received at least 1 delivery 2. Fresh Food Generation: received at least delivery 3. 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 Outcomes (6)

• Preventable ED visits

  12 months pre-outreach compared to 12 months after outreach is completed

• Avoidable Inpatient Hospitalizations

  12 months pre-outreach compared to 12 months after outreach is completed

• Outpatient no-show rate

  12 months pre-outreach compared to 12 months after outreach is completed

• BMI for patients who are overweight/obese

  12 months pre-outreach compared to 12 months after outreach is completed

• A1c for patients with Impaired Fasting Glucose/Diabetes

  12 months pre-outreach compared to 12 months after outreach is completed

Study Arms (3)

High Intensity Proactive Outreach

EXPERIMENTAL

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.

Other: High Intensity Proactive Outreach

Low Intensity Proactive Outreach

EXPERIMENTAL

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.

Other: Low Intensity Proactive Outreach

No Outreach; Usual Care

NO INTERVENTION

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.

Interventions

High Intensity Proactive Outreach OTHER

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

High Intensity Proactive Outreach

Low Intensity Proactive Outreach OTHER

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

Low Intensity Proactive Outreach

Eligibility Criteria

• Age: 3 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• a Complex Physical Health Need
• a Behavioral Health Need
• a High Risk Pregnancy or
• Repeated ED use.
• A Complex Physical Health Need is defined as having a diagnosis of one or more of the following:
• Obesity (adults with BMI \> 30, pediatrics with weight in 95-99 percentiles)
• Diabetes
• Hypertension
• Chronic kidney disease or end stage renal disease
• Chronic heart failure
• Adult or pediatric cancer diagnosis
• Malnutrition
• Failure to thrive
• Gastrointestinal disease (e.g. inflammatory bowel disease such as Crohn's or Ulcerative Colitis)

You may not qualify if:

• Language other than English, Arabic, Spanish, or Creole.
• Language unknown
• Age\> 64.5 years (patients age out of the Medicaid ACO at 65, and this is a 6 month intervention)
• Previous referral (already in database whether or not enrolled)
• Invalid address (e.g. exclude address="NPA")
• No phone number
• Same address as another patient in report (randomly select 1 to retain)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Officials

• Sarah Matathia, MD MPH

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saja Alani, MPH

CONTACT

617-726-1369; salani@mgh.harvard.edu

Suzanne Brodney, PHD

CONTACT

617-643-4226; SBRODNEY@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Medical Director of Primary Care Equity

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share