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临床试验/NCT05893446
NCT05893446尚未招募不适用

Essential Connections: How Improved Referrals From Hospital to Community Meal Provision Can Impact Malnutrition Outcomes in Older Adults

Academy of Nutrition and Dietetics0 个研究点目标入组 1,120 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,120
主要终点
Quality of Life Scale (CASP-19)

研究概览

简要总结

Meal provision organizations, whether they provide meals within the home or in congregate centers, provide an excellent opportunity to address malnutrition by providing nutrition care and meals to those who are most vulnerable. Data has shown that nutrition care within the home by a dietitian can increase energy, protein intake, and body weight. The goal of this study is to test a new model for continuity of nutrition care for malnutrition treatment across settings and determine if it improves food security and quality of life in patients 60 years and older. The study will specifically recruit sites and a sample that represents individuals who have malnutrition, have experienced or are at risk for food insecurity, and those from rural areas as well as Black, Latino, Indigenous and Native American populations with a goal sample size of 1,120 patients over the five-year duration. The objectives of this study are to: 1) test the feasibility of a patient identification, cross-referral, data reporting, and communication process from an acute care hospital to a community meal provision organization; 2) identify barriers to and facilitators for implementation as well as costs of the new model of continuity of nutrition care across settings; and 3) improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition. Level 1 evidence will be generated from the study. The outcomes to be measured are program sustainability, percent change in referrals, food insecurity, malnutrition risk and diagnosis, and quality of life. The results of this study can provide a new model for nutrition care that may improve food security, quality of life, and health outcomes.

详细描述

We hypothesize that enhanced continuity of nutrition care between acute care hospital settings and community meal provision organizations providing Title III-C Special Need Plan services (C1 and C2) will be sustainable and improve outcomes for patients older than 60 years of age who are diagnosed with malnutrition. Specifically, the enhanced continuity of care will: a) increase referrals and communication between clinical and community nutrition care providers at each study site location; b) increase the percent of patients receiving nutrition care within the community setting; and c) improve food security, quality of life, and reduce determinants of malnutrition.

To test this hypothesis, we propose to conduct a study which will examine a new model of continuity of nutrition care for sustainability and impact. The model has been developed to facilitate cross-referrals and transmission of structured nutrition care documentation from an acute care setting to a meal provision organization and then for the meal provision organization to use the referral data to increase delivery of nutrition care (medical nutrition therapy- MNT) and meals (medically tailored meals - MTM). The primary subjects for this study are adults older than 60 years of age with malnutrition, with particular emphasis on recruiting sites who serve individuals who are Black, Latino, Indigenous and Native Americans and individuals living in rural areas of the country.

The components of the proposed new model of cross-referral, data transfer, and nutrition care across settings has the potential to be scalable throughout the US. However, barriers and facilitators to data transfer and MNT/MTM provision, cost of implementation, and potential impact on outcomes must be evaluated for the model to be replicable. The results of this study will generate new data on the model of care feasibility, rates of malnutrition within older adults at the study sites, impact of MNT with MTM provision on food security, determinants of malnutrition, and quality of life to inform future scalability of the model.

Goals and Objectives The goal of this new model is to improve food security and quality of life in patients 60 years and older from key vulnerable populations with greatest social and economic need by providing continuity of nutrition care for malnutrition treatment across settings. To test the feasibility of this new model, we will use a stepped wedge cluster-randomized trial design at eight sites throughout the US, specifically recruiting sites and individuals who are Black, Latino, Indigenous and Native American, and individuals living in rural areas of the country. The Academy of Nutrition and Dietetics (the Academy), as the research organization, and the Academy of Nutrition and Dietetics Foundation (Academy Foundation) will partner with collaborating organizations in both acute care hospitals and meal provision organizations (Title III-C1 and C2) within the community to test the newly developed model.

Objective 1) To test the feasibility of a patient identification, cross-referral, data reporting, and communication (including data transfer) process from an acute care hospital to a community meal provision organization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English or Spanish speaking,
  • Screened as at risk for malnutrition (Malnutrition Screening Tool),
  • Meet the definition for food insecure per the Food Security Risk tool,
  • Referred to an RDN,
  • Diagnosed with malnutrition using AAIM,
  • Plan for discharge to home, and
  • Eligible to receive Title III-C1 or Title III-C2 nutrition services.

排除标准

  • Patients are receiving hospice care or care for end stage cancer,
  • Unable to consume meals (e.g., using enteral or parenteral to meet nutrition needs), Do not live within the meal provision organizations catchment.

结局指标

主要结局

Quality of Life Scale (CASP-19)

时间窗: 3 months

This tool has been validated in older populations and examined in populations with lower socioeconomic status and in different racial and ethnic populations. It will be conducted to evaluate the change in quality of life over time as a result of the intervention.

次要结局

  • Program Sustainability Assessment Tool(Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4)
  • Malnutrition risk(baseline in hospital and at 3 months post discharge from the hospital)
  • Food Security Risk(3 months post discharge from the hospital)
  • RDN Survey on Barriers and Facilitators to Implementation(Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4)
  • Change in percent of patients receiving nutrition care and meals(3 months)
  • Malnutrition Diagnosis (AAIM tool)(3 months post discharge from the hospital)

研究者

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

Alison L Steiber

Chief Science Officer

Academy of Nutrition and Dietetics

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