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临床试验/NCT05972421
NCT05972421尚未招募不适用

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

Massachusetts General Hospital0 个研究点目标入组 255 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
255
主要终点
Utilization of the Flex Nutrition Program

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
3 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)
  • •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)
  • •Asthma and two or more uncontrolled exacerbations per year
  • •COPD and two or more exacerbations per year High cholesterol
  • •Vitamin D deficiency or receiving Vitamin D supplements
  • •A Behavioral Health Need is defined as one or more of the following:
  • •Major depressive disorder
  • •Generalized anxiety disorder
  • •Bipolar disorder
  • •Schizophrenia
  • •Mood disorder (pediatric)
  • •Developmental disorders (e.g. autism)
  • •Substance use disorders or
  • •(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:
  • •hypertensive disorders of pregnancy
  • •pregestational or gestational diabetes
  • •a referral to or care with a Maternal Fetal Medicine specialist or
  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: High Intensity Proactive Outreach (Other)

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.

干预措施: Low Intensity Proactive Outreach (Other)

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.

结局指标

主要结局

Utilization of the Flex Nutrition Program

时间窗: 3 months after outreach is complete

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.

Referred to Flex Nutrition Program

时间窗: 3 months after outreach is completed

The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO)

Enrollment into the Flex Nutrition Program

时间窗: 3 months after outreach is completed

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.

Enrollment in the Flex Nutrition Program by Vendor

时间窗: 3 months after outreach is complete

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.

次要结局

  • 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)
  • Avoidable Inpatient Hospitalizations(12 months pre-outreach compared to 12 months after outreach is completed)
  • Blood Pressure for patients with HTN(12 months pre-outreach compared to 12 months after outreach is completed)
  • Preventable ED visits(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah A. Matathia, MD, MPH

Associate Medical Director of Primary Care Equity

Massachusetts General Hospital

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