Deliver-EE: Evaluating Effects of Meal Delivery

Healthy Clinical Trial

Official title:

Deliver-EE: Evaluating Effects of Meal Delivery on the Ability of Homebound Older Adults to Remain in the Community Via A Pragmatic, Two-Arm, Randomized Comparative Effectiveness Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357261
• Other study ID #: 2022003287
• Secondary ID: IHS-2020C3-21201
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Brown University
• Contact: Kimberly Bernard, PhD
• Phone: (401) 863-1842
• Email: kimberly_bernard[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will randomly assign 2,300 older adults on waiting lists at nine Meals on Wheels programs in Florida, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome.

Description:

Background and Significance: Food insecurity among older adults is a critical public health issue with implications for families, the healthcare system, and society. In 2017, an estimated 5.5 million older adults (7.7%) in the United States were food insecure. Among older adults, food insecurity is associated with poor health status and outcomes and accounts for an estimated $130 billion annually in medical expenses. As a result, healthcare entities (e.g., payers, integrated systems, providers) are increasingly interested in addressing food insecurity, among other social risk factors, through non-medical services such as home-delivered meals to older patients and enrollees. Home-delivered meals, long provided through a network of community-based organizations funded through the Older Americans Act, state dollars, and charitable contributions, promote food security, socialization, and independence among older adults. While meals have traditionally been provided daily to clients' homes by a volunteer or paid driver, mailed frozen meals have emerged in recent years as a lower cost alternative. However, there is limited evidence about what mode of delivery is most effective in promoting community independence, reducing healthcare utilization, and improving patients' quality of life, as well as how these outcomes may vary as a function of patients' preferences for how meals are delivered to them.

Study Aims: The long-term goal of this research is to generate evidence to guide patient, family, meal programs, and healthcare entities' decision-making about which mode of meal delivery is best for promoting important, patient-centered outcomes. This will be accomplished through three specific aims: 1) To evaluate the effectiveness of receiving daily-delivered meals with a safety check and socialization versus frozen, drop-shipped meals on food insecure, homebound older adults' ability to remain in the community; 2) To understand food insecure, homebound older adults' preferences for mode of meal delivery and the effect of receiving a meal that is concordant with their preference on their ability to remain in the community; and 3) To measure and quantify secondary outcomes prioritized by stakeholders related to these different modes of meal delivery.

Study Description: This is a two-arm pragmatic, randomized controlled trial that will compare participants' health outcomes between two conventional approaches for delivering meals to food insecure, homebound older adults at nine diverse Meals on Wheels America member programs in Florida, Texas, California, North Carolina, and South Carolina. The comparators are the two main modes of meal delivery used in everyday practice: daily-delivered meals and drop-shipped, frozen meals. A total of 2300 food insecure, homebound older adults (ages 66+) on waiting lists at these programs will be enrolled in the study; 1150 older adults will receive meals delivered five days per week, with socialization and a wellness check by a volunteer or paid driver, and 1150 will receive a box of 10 frozen meals that will be mailed to participants every two weeks. The primary outcome will be the ratio of days that a participant is in an institutional setting (i.e., hospital, nursing home) in the six months following the start of meal delivery and will be derived from data from the Centers for Medicare and Medicaid Services; secondary outcomes include the ratio of days in institutional settings in the three months following the start of meal delivery, food insecurity, loneliness, and quality of life. Secondary outcomes will be derived from Centers for Medicare and Medicaid Services' data and surveys with participants. Self-reported dietary intake will be included as an exploratory outcome. To examine heterogeneity of treatment effects, the investigators will test for interactions between the two types of meals and participants' preferences for meals, as well as clients' living arrangements. This research will be the first to prospectively evaluate the comparative effectiveness of the two predominant meal delivery options in partnership with a variety of stakeholders. The knowledge generated from this research will be of tremendous value to healthcare payers, health systems, providers, community-based organizations, patients, and their families, because it will identify the mode of meal delivery that best meets older, homebound, and food insecure patients' needs and promotes community independence

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• Age 66+

• On program waiting list

• Must reside in program's daily service area

• Must be able to eat a general diet with no dietary restrictions

Exclusion Criteria:

• Primary language is not English or Spanish

• Has end stage renal disease/requires specialized renal diet

• Unable to participate in a phone survey/interview (e.g., difficulty hearing, lack of comprehension of study purpose, does not have working phone)

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Wellness Check and Socialization
In-home delivery with opportunity for driver observation and interaction

Other:
• Prepared Meals
Prepared meals compliant with Older Americans Act nutrition programs guidelines

Locations

Country	Name	City	State
United States	Meals On Wheels - Anderson	Anderson	South Carolina
United States	Neighborly Care Network	Clearwater	Florida
United States	Senior Resources Inc	Columbia	South Carolina
United States	Visiting Nurse Association of Texas	Dallas	Texas
United States	Meals On Wheels Durham	Durham	North Carolina
United States	Meals on Wheels Northeastern Illinois	Evanston	Illinois
United States	Senior Resources of Guilford	Greensboro	North Carolina
United States	Aging True	Jacksonville	Florida
United States	Meals on Wheels San Antonio	San Antonio	Texas
United States	Meals on Wheels San Diego County	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Johns Hopkins University, Meals on Wheels America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Month Ratio of Days in Institutional Settings	Ratio between the number of days that are spent in an institutional setting (i.e., acute care hospital, psychiatric hospital, long-term care hospital, nursing home, or skilled nursing facility) and the number of days alive in the six months following receipt of meals	6 months
Secondary	3-Month Ratio of Days in Institutional Settings	Defined similarly to the primary outcome, but assesses the immediate (3-month) impact of meals on days spent in institutional settings	3 months
Secondary	Food Insecurity	U.S. Household Food Security Survey Module: Six-Item Short Form; Minimum value (0) indicates high food insecurity; Maximum value (6) indicates very low food insecurity	3 months
Secondary	Subjective Isolation/Loneliness	University of California, Los Angeles 3-Item Loneliness Scale; Minimum value (3) indicates low feelings of loneliness; Maximum value (9) indicates high feelings of loneliness	3 months
Secondary	Health-Related Quality of Life	The Centers for Disease Control and Prevention's Health-Related Quality of Life 4-question core modules, called the "Healthy Days Measures"; The unhealthy days index is calculated by summing the number of physically and mentally unhealthy days, capped at 30 total days.	3 months