Progress 09/01/19 to 08/31/22
Outputs
Target Audience:This randomized control study of Fresh Connect services aims to address food insecuirity among low-income patients in our Medicaid Accountable Care Organization, Massachusetts' largest Medicaid ACO. Our efforts throughout the duration of the project targeted families of young children receiving healthcare at Boston Medical Center's Pediatrics. Many of these families are low-income, living in the Greater Boston area and are Medicaid recipients. Study participant were recruited through Project REACH, an outreach project that represent the standard of care with the Pediatrics Department. Below are the IRB- approved inclusion criteria that had to be met by study participants in order to be enrolled in the study: Woman is biological mother of at least one 0- to 24-month-old child receiving care at Boston Medical Center. Woman is at least 18 years-old Woman is comfortable speaking and receiving information in English or Spanish Primary residence is in a zip code serviced by the Fresh Connect program Changes/Problems:One major change that occurred in October of 2021 was Dr. Michael Silverstein departing from BMC and Co-Investigator Dr. Caroline Kistin becoming the new Principal Investigator of the study. We worked closely with GusNIP and BMC/BUMC's IRB to ensure a smooth transition. Given that Dr. Kistin was already involved in the study, we didn't face any major problems. What opportunities for training and professional development has the project provided? Informal data sharing, systems, and research-related trainings between BMC and About Fresh (ongoing throughout the reporting period.) Fresh Connect held a training for new Fresh Connectcards with research members on September 3, 2021. How have the results been disseminated to communities of interest?Data analysis is still in progress. Thus, results have not yet been disseminated at this time. We will complete data collection in February 2023. Once that has occurred, our team will work on analyzing the data. The results will then be disseminated to Fresh Connect. We also plan to put together manuscripts and presentations (academics and with Fresh Connect and the community). What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Final data collection and data analysis are still in progress with regards to evaluating the impact of the intervention on fruit and vegetable consumption, food insecurity, and utilization of acute care services. The goal of this RCT was to enroll a total of 250 study participants, of which 124 would be randomized to the Fresh Connect comparator arm. In February 2022 we met our full recruitment goal for the study. Throughout the study period we have successfully maintained a high follow up engagement rate. Follow-up rates updated on August 11, 2002 can be found in the table below. We have been able to have success by having a team of research assistants that are multilingual, multicultural, flexible and accessible to meet the availability of research study participants. Throughout the study we have also submitted our monthly reports to the Nutrition Incentive Hub and have met with our partners at the GusNIP NTAE Center to discuss the data. This study has successfully provided access to Fresh Connect to 124 families. Fresh Connect has issued over $136,000 in produce prescription program incentives as of June 2022. There has also been an increase in access to more F&V providers including Stop & Shop and Daily Table through Fresh Connect's updates on its Fresh Connect Card. Interview # of interviews completed, (%) Baseline 124 (100%) 1-month 117 (94.4%) 2-month 117 (94.4%) 3-month 110 (88.7%) 4-month 112 (90.3%) 5-month 110 (88.7%) 6-month 97 (78.2%) 7-month 100 8-month 94 9-month 88 10-month 82 11-month 78 12-month 58
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Progress 09/01/20 to 08/31/21
Outputs
Target Audience:Our project is a randomized study of Fresh Connect services to address food insecurity among low-income patients inBoston Medical Center's (BMC)Medicaid Accountable Care Organization - Massachusetts' largest Medicaid accountable care organization. Our efforts this reporting period targeted families with young children who receive care at theBMC Department of Pediatrics, many of whom are low-income, urban families who are Medicaid recipients. We are specifically targeting families who meet all of the following criteria: Woman is biological mother of at least one 0- to 24-month-old child receiving care at BMC Woman is at least 18 years of age Primary residence is in a zip codeserviced by the Fresh Connect program Woman is comfortable speaking and receiving information in English or Spanish This study will enroll 250 English- or Spanish-speaking mother-child dyads into the study, 125 of whom will receive the Fresh Connect comparator arm. As of August 20, 2021, we had enrolled N=151 mother-child dyads into the study; 73 of those enrolled were randomized to the Fresh Connect comparator arm. Changes/Problems:As discussed with USDA program officers and in our Progress Report submitted in August 2020, funding delays and COVID-related human subject research restrictions resulted in project launch and recruitment delays. We held spending on some budget line items of the grant knowing we will need those funds upon project launch. Given these delays, we authorized our right to our first No Cost Extension, extending the project period to 8/31/2022. We officially launched the project in February 2021. Activities in the No Cost Extension period will entail delivering the comparator arms of the study and following all participant families to assess and compare outcomes. What opportunities for training and professional development has the project provided? BMC research staff provided 20 Department of Pediatrics clinical outreach staff an in-service training on study eligibility criteria and recruitment activities, January 2021 - August 2021. BMC research staff trained 4 individuals to conduct follow-up assessments among participants enrolled in the BMC Fresh Connect research study. All study personnel were also trained to manage a mental health crisis (including suicidal ideation) should it occur during the study. BMC research staff and About Fresh staff attended the GusNIP NTAE Nutrition Incentive Practitioner Virtual Convening (March 10-11, 2021). About Fresh partners presenteda session at the convening. BMC research staff, along with members of the About Fresh team, attended various workshops and community of practice webinars provided by the GusNIP NTAE (ongoing throughout the reporting period). Informal data sharing, systems, and research-related trainings between BMC and About Fresh (ongoing throughout the reporting period). How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? Continue study recruitment and enrollment efforts. Continue to implement study interventions. Conduct participant-level baseline assessments and follow-up assessments. Submit monthly and annual reports to GusNIP NTAE Center, including submission of core evaluation data. Continue regular meetings with About Fresh and GusNIP NTAE.
Impacts
What was accomplished under these goals?
Impact: This study focuses on improving outcomes related to disrupted systems of care caused by the COVID-19 pandemic. Specifically, this study aims to compare systems to address food insecurity among families with children who receive care at the BMC Department of Pediatrics, many of whom are low-income, urban families who are Medicaid recipients. To achieve these aims, we are currently conducting a randomized trial to compare the effectiveness of two approaches:1) a produce prescription program (Fresh Connect) that gives families a monthly stipend to purchase fresh foods at mobile food and farmers markets; and 2) an equal monetary value of gift cards redeemable at conventional grocery stores. Fresh Connect is a smart gift card payment system developed by About Fresh that enables health care providers to cover the cost of healthy foods and provides information on fruits and vegetables (F&V) that patients can purchase at its mobile markets and neighborhood farmers markets across Boston, MA. Our randomized design is based on the premise that there is equipoise in how to address food insecurity most effectively in the context of the COVID-19 pandemic. Knowing which comparator is better at reducing food insecurity is critical to helping low-income families during and after the pandemic. Accomplishments during the reporting period: The goals of the BMC Fresh Connect project are: 1) to increase the consumption of fruits and vegetables by BMC Medicaid patients; 2) to reduce food insecurity in these patients; and 3) to reduce their health care costs by reducing utilization of acute care services. Activities included: To overcome COVID-related research restrictions, we embedded our research study into an existing Department of Pediatrics clinical program to recruit for the study via telephone. Under this Department of Pediatrics clinical program, families receive proactive outreach calls made by members of a designated clinical care team to assess basic needs.We will embed a "study option" into the clinical algorithm for eligible families who live in an area that is serviced by Fresh Connect. Specifically, for families who may meet study eligibility criteria, the possibility of learning more about the study will be presented in addition to the standard menu of options. Received IRB approval for the revised study protocol on December 21, 2020. Research staff trained research team and study partners on study protocols and activities. Research team launched study recruitment efforts in February 2021. Our partner firm, About Fresh, began providing Fresh Connect services to participants randomized to the Fresh Connect comparator arm in February 2021. As of August 20, 2021, we have enrolled 151 total participants into the study (73 randomized to the Fresh Connect comparator arm). Conducted 73 baseline assessmentsamong Fresh Connect comparator arm participants as of August 20, 2021. Conducted 3 6-month follow-up assessments as of August 20, 2021 Submitted monthly and quarterly reports to GusNIP NTAE Center, including submission of core evaluation data.
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Progress 09/01/19 to 08/31/20
Outputs
Target Audience:
Nothing Reported
Changes/Problems:As discussed with Paul Cotton (email communication March 26, 2020) and Mallory Koenigs and Helen Chipman (telephone communication October 1, 2020), Boston Medical Center froze on all in-person human subject research activities, including recruiting subjects, beginning March 2020. This resulted in project launch and recruitment delays. Because of these restrictions, we held spending on some budget line items of the grant - knowing we will need those funds at a later date. Simultaneously, we identified an opportunity to recruit and enroll for the study via telephone to overcome research restrictions. Because of the modifications, we had to hold on submitting our IRB protocol for approval until a viable method to conduct the project became clear. The IRB is currently under review. It is certain that we will require at least one no-cost extension to complete the study, but it is possible that another may be necessary should further delays beyond our control occur with another COVID surge. What opportunities for training and professional development has the project provided? BMC research staff conducted a half-day training for our About Fresh, Inc. firm partners on pragmatic research and practical implications for collaborating firm organizations (February 20, 2020). BMC research staff attended the GusNIP NTAE Nutrition Incentive Practitioner Virtual Convening (March 18-20, 2020). BMC research staff, along with members of the About Fresh team, attended various workshops and community of practice webinars provided by the GusNIP NTAE (ongoing throughout the reporting period). How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? Receive IRB approval for the revised study protocol. Begin recruitment for study. Implement study interventions. Conduct participant-level baseline assessments and begin follow-up assessments. Submit monthly and quarterly reports to GusNIP NTAE Center, including submission of core evaluation data.
Impacts
What was accomplished under these goals?
Impact: BMC patients will receive a Fresh Connect smart card, which can be redeemed at any of Fresh Truck's mobile markets. Wehave designed a rigorous randomized trial to establish scientific evidence to determine the effectivenessof theBMC Fresh Connect programin: 1) increasingconsumption of F&V; 2) lowering food insecurity;and 3) loweringutilization of acute health care services and total cost of care. Accomplishments during the reporting period: Our study team pivoted to a telephone recruitment model in response to BMC's institutional hold on all in-person human subject research activities secondary to the COVID pandemic. Accomplishments during this reporting period include: Modification of the IRB protocol to embed research recruitment and enrollment within a clinic-based call center launched in response to the pandemic. The call center proactively outreaches to families who receive primary care at BMC to assess basic needs (including food insecurity) during the pandemic. Execution of the BAA and MOU with our partner firm, About Fresh, Inc. Project evaluation finalization with our GusNIP NTAE contacts, including collecting core evaluation data.
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