xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972421</url>
    </required_header>
    <id_info>
      <org_study_id>2022P002954</org_study_id>
      <nct_id>NCT05972421</nct_id>
    </id_info>
    <brief_title>Enrollment in and Utilization of the Flex Nutrition Program</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the impact of proactive outreach on&#xD;
        enrollment into and utilization of the Flexible Services Nutrition Program. The Flexible&#xD;
        Services Nutrition Program increases access to healthy foods for patients with Medicaid ACO&#xD;
        insurance, food insecurity and nutritionally dependent chronic health conditions.&#xD;
  &#xD;
        The main questions the study aims to answer are:&#xD;
  &#xD;
          -  Does proactive outreach to eligible patients increase enrollment into the Medicaid ACO&#xD;
             FLEX Nutrition Program, compared to usual care?&#xD;
  &#xD;
          -  Does high intensity outreach (letter +phone calls) increase enrollment more than low&#xD;
             intensity outreach (letter only)?&#xD;
  &#xD;
        The investigators will also conduct exploratory analyses to evaluate if proactive outreach&#xD;
        has an effect on healthcare utilization (ED visits, unplanned hospitalizations, and&#xD;
        outpatient no-show rate) and health outcomes (BMI for patients with overweight/obesity, a1c&#xD;
        for patients with impaired fasting glucose/Diabetes, Blood Pressure for patients with&#xD;
        Hypertension).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Medicaid ACO Flexible Services Program is a pilot that allocates state funding to address&#xD;
        certain health-related social needs, in the domains of food and housing, with the goal of&#xD;
        improving health outcomes and reducing the total cost of health care for members. The Flex&#xD;
        Nutrition Program specifically allows members with a health needs-based criteria (such as a&#xD;
        complex physical health need, repeated Emergency Department use or a high-risk pregnancy) who&#xD;
        are experiencing food insecurity (defined as a positive screening on the Hunger Vital Sign&#xD;
        questionnaire) to receive nutritional support.&#xD;
  &#xD;
        At MGH, the investigators have partnered with 3 Social Service Organizations (SSOs) to&#xD;
        deliver 3 types of nutritional support. Community Servings provides medically tailored meals&#xD;
        with nutritional counseling. Fresh Food Generation provides healthy food boxes. Fresh Connect&#xD;
        provides debit cards with monthly allotments that can be used to purchase produce.&#xD;
  &#xD;
        The current workflow for identifying and enrolling appropriate ACO members relies largely on&#xD;
        referrals from Primary Care Teams. Role groups who respond to social needs within primary&#xD;
        care, such as Community Health Workers, integrated Care Managers, Community Resource&#xD;
        Navigators and Emergency Department Navigators (collectively herein referred to as Care&#xD;
        Managers), have been trained on the program's eligibility requirements and encouraged to&#xD;
        offer enrollment to the patients they are working with. However, this current method in&#xD;
        inadequate to identify many eligible patients. Only a very small subset of patients (less&#xD;
        than 10%) with social needs identified on their primary care screening questionnaire are&#xD;
        referred to Care Managers. In addition, Care Managers do not have any consistent method for&#xD;
        identifying patients and offering the Flex Nutrition Program.&#xD;
  &#xD;
        For patients interested in enrollment, Care Managers refer to two dedicated FLEX staff. Upon&#xD;
        receipt of a referral, these two staff complete a Verification, Planning and Referral (VPR)&#xD;
        form in EPIC, which generates a referral for the appropriate SSO, who subsequently reaches&#xD;
        out to enroll the patient.&#xD;
  &#xD;
        The investigators seek to understand if proactive outreach to eligible patients increases&#xD;
        enrollment into and utilization of the Medicaid ACO Flex Nutrition Program. To answer this&#xD;
        question, the investigators will identify eligible members (patients in the Medicaid ACO with&#xD;
        a positive food insecurity screening plus one or more defined health conditions, see&#xD;
        Inclusion criteria for more details) via an EPIC Report and randomize them into 3 cohorts.&#xD;
        Cohort A will receive high intensity proactive outreach via phone, Cohort B will receive&#xD;
        low-intensity outreach via letter and Cohort C will receive usual care with no proactive&#xD;
        outreach. The investigators will use an EPIC report to generate a list of eligible patients,&#xD;
        defined as Adult and Pediatric patients cared for within MGH Primary Care in the Medicaid ACO&#xD;
        with a health needs-based criteria and a positive screening for food insecurity. Patients&#xD;
        already enrolled into the Flex Nutrition program will be excluded.&#xD;
  &#xD;
        The rationale for randomization is that our 2 FLEX staff have limited bandwidth to&#xD;
        proactively outreach to all eligible patients. Randomizing eligible patients will ensure&#xD;
        their efforts are distributed fairly and also allow the investigators to evaluate the&#xD;
        effectiveness of low intensity and high intensity outreach. The Flex Services Nutrition&#xD;
        Program is incorporated into routine clinical care at MGH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Referred to Flex Nutrition Program</measure>
      <time_frame>3 months after outreach is completed</time_frame>
      <description>The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Enrollment into the Flex Nutrition Program</measure>
      <time_frame>3 months after outreach is completed</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Enrollment in the Flex Nutrition Program by Vendor</measure>
      <time_frame>3 months after outreach is complete</time_frame>
      <description>For patients enrolled into Flex Nutrition, the percentage breakdown by SSO vendor&#xD;
  Community Servings&#xD;
  Fresh Food Generation&#xD;
  Fresh Connect We will utilize SSO rosters of enrolled patients as our data source.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Utilization of the Flex Nutrition Program</measure>
      <time_frame>3 months after outreach is complete</time_frame>
      <description>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&#xD;
  Community Servings: received at least 1 delivery&#xD;
  Fresh Food Generation: received at least delivery&#xD;
  Fresh Connect: have charged their card at least once We will utilize SSO rosters of patients receiving services as our data source.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preventable ED visits</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>Number of ED visits that did not result in an admission 12 months pre-outreach compared to 12 months after outreach is completed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Avoidable Inpatient Hospitalizations</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>Unplanned inpatient hospitalizations 12 months pre-outreach compared to 12 months after outreach is completed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Outpatient no-show rate</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>No show rate during the 12 months pre-outreach period compared to 12 months after outreach is completed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI for patients who are overweight/obese</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>Of patients with elevated BMI (defined as BMI&gt;25 prior to outreach completed), change in pre-outreach BMI compared to 12 months after outreach is completed&#xD;
  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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>A1c for patients with Impaired Fasting Glucose/Diabetes</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>Of patients with IFG/Diabetes (defined as Diagnosis of IFG/DM AND/OR a1c &gt; 5.7 prior to outreach completed), change in pre-outreach a1c compared to 12 months after outreach is completed.&#xD;
  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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure for patients with HTN</measure>
      <time_frame>12 months pre-outreach compared to 12 months after outreach is completed</time_frame>
      <description>Of patients with Hypertension (defined as Diagnosis of Hypertension AND/OR BP &gt; 130/80 prior to outreach completed), change in pre-outreach Blood Pressure compared to 12 months after outreach is completed.&#xD;
  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.)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">255</enrollment>
    <condition>Food Insecurity</condition>
    <condition>Vulnerable Populations</condition>
    <condition>Nutrition, Healthy</condition>
    <arm_group>
      <arm_group_label>High Intensity Proactive Outreach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low Intensity Proactive Outreach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive a mailed letter. The objective of the letter is to describe the Flex Nutrition Program and offer enrollment.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Outreach; Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>High Intensity Proactive Outreach</intervention_name>
      <description>phone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program</description>
      <arm_group_label>High Intensity Proactive Outreach</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Low Intensity Proactive Outreach</intervention_name>
      <description>mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program</description>
      <arm_group_label>Low Intensity Proactive Outreach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Has Medicaid ACO as primary health insurance, confirmed food insecurity (defined as a&#xD;
          positive screen on the Hunger Vital Sign, which is conducted in routine care within primary&#xD;
          care) AND one of the following:&#xD;
  &#xD;
            1. a Complex Physical Health Need&#xD;
  &#xD;
            2. a Behavioral Health Need&#xD;
  &#xD;
            3. a High Risk Pregnancy or&#xD;
  &#xD;
            4. Repeated ED use.&#xD;
  &#xD;
          A Complex Physical Health Need is defined as having a diagnosis of one or more of the&#xD;
          following:&#xD;
  &#xD;
            1. Obesity (adults with BMI &gt; 30, pediatrics with weight in 95-99 percentiles)&#xD;
  &#xD;
            2. Diabetes&#xD;
  &#xD;
            3. Hypertension&#xD;
  &#xD;
            4. Chronic kidney disease or end stage renal disease&#xD;
  &#xD;
            5. Chronic heart failure&#xD;
  &#xD;
            6. Adult or pediatric cancer diagnosis&#xD;
  &#xD;
            7. Malnutrition&#xD;
  &#xD;
            8. Failure to thrive&#xD;
  &#xD;
            9. Gastrointestinal disease (e.g. inflammatory bowel disease such as Crohn's or&#xD;
               Ulcerative Colitis)&#xD;
  &#xD;
           10. Asthma and two or more uncontrolled exacerbations per year&#xD;
  &#xD;
           11. COPD and two or more exacerbations per year High cholesterol&#xD;
  &#xD;
           12. HIV / AIDs&#xD;
  &#xD;
           13. Vitamin D deficiency or receiving Vitamin D supplements&#xD;
  &#xD;
          A Behavioral Health Need is defined as one or more of the following:&#xD;
  &#xD;
            1. Major depressive disorder&#xD;
  &#xD;
            2. Generalized anxiety disorder&#xD;
  &#xD;
            3. Bipolar disorder&#xD;
  &#xD;
            4. Schizophrenia&#xD;
  &#xD;
            5. Mood disorder (pediatric)&#xD;
  &#xD;
            6. Developmental disorders (e.g. autism)&#xD;
  &#xD;
            7. Substance use disorders or&#xD;
  &#xD;
            8. (for adults) an individual with PHQ-9 score or GAD-7 score of 10 or greater.&#xD;
  &#xD;
          High Risk Pregnancy is defined as:&#xD;
  &#xD;
          High risk pregnant individual with a diagnosis of:&#xD;
  &#xD;
            1. hypertensive disorders of pregnancy&#xD;
  &#xD;
            2. pregestational or gestational diabetes&#xD;
  &#xD;
            3. a referral to or care with a Maternal Fetal Medicine specialist or&#xD;
  &#xD;
            4. other high-risk, high-acuity diagnoses that can benefit from meeting an unmet social&#xD;
               need&#xD;
  &#xD;
          Repeated ED Use is defined as:&#xD;
  &#xD;
          2+ ED visits in last 6 months or 4+ ED visits in last 12 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Language other than English, Arabic, Spanish, or Creole.&#xD;
  &#xD;
            2. Language unknown&#xD;
  &#xD;
            3. Age&gt; 64.5 years (patients age out of the Medicaid ACO at 65, and this is a 6 month&#xD;
               intervention)&#xD;
  &#xD;
            4. Previous referral (already in database whether or not enrolled)&#xD;
  &#xD;
            5. Invalid address (e.g. exclude address=&quot;NPA&quot;)&#xD;
  &#xD;
            6. No phone number&#xD;
  &#xD;
            7. Same address as another patient in report (randomly select 1 to retain)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah Matathia, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>MGH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saja Alani, MPH</last_name>
      <phone>617-726-1369</phone>
      <email>salani@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Suzanne Brodney, PHD</last_name>
      <phone>617-643-4226</phone>
      <email>SBRODNEY@mgh.harvard.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Sarah A. Matathia, MD, MPH</investigator_full_name>
      <investigator_title>Associate Medical Director of Primary Care Equity</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972421
  org study id: 2022P002954
  nct id: NCT05972421
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Referred to Flex Nutrition Program
  time frame: 3 months after outreach is completed
  description: The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO)
  measure: Enrollment into the Flex Nutrition Program
  time frame: 3 months after outreach is completed
  description: 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.
  measure: Enrollment in the Flex Nutrition Program by Vendor
  time frame: 3 months after outreach is complete
  description: 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.
  measure: Utilization of the Flex Nutrition Program
  time frame: 3 months after outreach is complete
  description: 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.
  measure: Preventable ED visits
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: Number of ED visits that did not result in an admission 12 months pre-outreach compared to 12 months after outreach is completed
  measure: Avoidable Inpatient Hospitalizations
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: Unplanned inpatient hospitalizations 12 months pre-outreach compared to 12 months after outreach is completed
  measure: Outpatient no-show rate
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: No show rate during the 12 months pre-outreach period compared to 12 months after outreach is completed.
  measure: BMI for patients who are overweight/obese
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: 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)
  measure: A1c for patients with Impaired Fasting Glucose/Diabetes
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: 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)
  measure: Blood Pressure for patients with HTN
  time frame: 12 months pre-outreach compared to 12 months after outreach is completed
  description: 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.)
  arm group label: High Intensity Proactive Outreach
  arm group type: Experimental
  description: 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.
  arm group label: Low Intensity Proactive Outreach
  arm group type: Experimental
  description: 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.
  arm group label: No Outreach; Usual Care
  arm group type: No Intervention
  description: 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.
  intervention type: Other
  intervention name: High Intensity Proactive Outreach
  description: phone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program
  arm group label: High Intensity Proactive Outreach
  intervention type: Other
  intervention name: Low Intensity Proactive Outreach
  description: mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program
  arm group label: Low Intensity Proactive Outreach
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Sarah Matathia, MD MPH
  role: Principal Investigator
  affiliation: MGH
  last name: Saja Alani, MPH
  phone: 617-726-1369
  email: salani@mgh.harvard.edu
  last name: Suzanne Brodney, PHD
  phone: 617-643-4226
  email: SBRODNEY@mgh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Sarah A. Matathia, MD, MPH
  investigator title: Associate Medical Director of Primary Care Equity
  sharing ipd: No