Deliver-EE: evaluación de los efectos de la entrega de comidas
Deliver-EE: evaluación de los efectos de la entrega de comidas en la capacidad de los adultos mayores confinados en el hogar para permanecer en la comunidad a través de un ensayo de eficacia comparativa pragmática, aleatoria y de dos brazos
This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 fourteen diverse Meals on Wheels America member programs in Florida, Illinois, Maryland, Tennessee, 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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92110
- Meals on Wheels San Diego County
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Florida
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Clearwater, Florida, Estados Unidos, 33762
- Neighborly Care Network
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Jacksonville, Florida, Estados Unidos, 32210
- Aging True
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Meals on Wheels Northeastern Illinois
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Meals on Wheels of Central Maryland
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North Carolina
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Durham, North Carolina, Estados Unidos, 27703
- Meals On Wheels Durham
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Greensboro, North Carolina, Estados Unidos, 27408
- Senior Resources of Guilford
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South Carolina
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Anderson, South Carolina, Estados Unidos, 29624
- Meals On Wheels - Anderson
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Columbia, South Carolina, Estados Unidos, 29205
- Senior Resources Inc
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38126
- Metropolitan Inter-Faith Association (MIFA)
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Texas
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Dallas, Texas, Estados Unidos, 75247
- Visiting Nurse Association of Texas
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Houston, Texas, Estados Unidos, 77090
- Northwest Assistance Ministries
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Mission, Texas, Estados Unidos, 78572
- Amigos Del Valle, Inc
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San Antonio, Texas, Estados Unidos, 78229
- Meals on Wheels San Antonio
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Daily home delivered meals
A lunch-time meal delivered to participants' homes five days per week with wellness check and socialization. |
In-home delivery with opportunity for driver observation and interaction Prepared meals compliant with Older Americans Act nutrition programs guidelines |
|
Experimental: Frozen, Drop-shipped Meals
Ten frozen meals that are mailed to participants every two weeks. |
Prepared meals compliant with Older Americans Act nutrition programs guidelines |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
6-Month Ratio of Days in Institutional Settings
Periodo de tiempo: 6 months
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
3-Month Ratio of Days in Institutional Settings
Periodo de tiempo: 3 months
|
Defined similarly to the primary outcome, but assesses the immediate (3-month) impact of meals on days spent in institutional settings |
3 months
|
|
Food Insecurity
Periodo de tiempo: 3 months
|
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
|
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Subjective Isolation/Loneliness
Periodo de tiempo: 3 months
|
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
|
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Health-Related Quality of Life
Periodo de tiempo: 3 months
|
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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kali S. Thomas, PhD, Johns Hopkins University School of Nursing
- Director de estudio: Kimberly P. Bernard, PhD, Brown University School of Public Health
Publicaciones y enlaces útiles
Publicaciones Generales
- Thomas KS, Bernard KP, Clark M, Dionne L, Fisher A, Gadbois E, Harrison J, Juckett L, Locher J, Risica P, Sequeira T, Theilheimer L, Gutman R. 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: study protocol for the Deliver-EE trial. Trials. 2024 Nov 22;25(1):787. doi: 10.1186/s13063-024-08635-3.
- Juckett LA, Bernard KP, Clark MA, Gadbois EA, Wright B, Thomas KS. Core functions and forms in home-delivered meal programs: a stakeholder-driven approach to identifying essential practices. Implement Sci Commun. 2025 Apr 14;6(1):43. doi: 10.1186/s43058-025-00728-7.
- Juckett LA, Bernard KP, Thomas KS. Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies. Trials. 2023 Nov 17;24(1):739. doi: 10.1186/s13063-023-07757-4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2022003287
- IHS-2020C3-21201 (Otro número de subvención/financiamiento: Patient-Centered Outcomes Research Institute)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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