Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05893446 |
| Other study ID # |
95INNU0045 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
May 31, 2028 |
Study information
| Verified date |
June 2023 |
| Source |
Academy of Nutrition and Dietetics |
| Contact |
Lindsay Woodstock, PhD |
| Phone |
3128994797 |
| Email |
lwoodstock[@]eatright.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Objective 1a) To identify barriers to and facilitators for implementation as well as the cost
of the new model of continuity of nutrition care across settings.
Objective 2) To increase the rate of patients older than 60 years of age with malnutrition
receiving care (MNT, MTM) in the community setting.
Objective 3) To 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.
There are two distinct portions of the study intervention: the clinical component, which
includes patient identification, effective cross-referrals, and enhanced data reporting and
transfer to the community partner, and the community component, including enhanced nutrition
care and reporting including both MNT and MTM. The meals and nutrition care within the
community can occur at home or within a congregate meal setting (Title III C1 and C2).
The study will compare the usual care process with no referral to the new model which
includes a referral and nutrition care in the community using a stepped wedge
cluster-randomized trial design.12 All participating sites will start in the control
condition (usual process/care) and then be randomized to unidirectionally crossover to the
intervention condition within four sequence blocks on a staggered schedule (see work plan
year 2 for detailed table). Patients diagnosed with malnutrition in the hospital setting will
be cross-sectionally identified and enrolled within each study period. All enrolled patients,
regardless of whether they are in the control or receive the intervention will have outcome
measures collected 3 months post-discharge (+/- two weeks). All sites will begin in the
control period and then two sites at a time will implement the intervention in a staggered
approach. Thus, in period 1 all are following usual care, then in period 2, two sites will
implement the new model, in period 3, two additional sites will implement it, and this will
continue until all sites have implemented the new model (intervention) at the end of period
5. Each period will last 7 months for a total study duration of 35 months. Patient
recruitment will occur within all 5 periods for a total of 1120 patients and at a rate of
approximately six to seven patients per month per site. This approach ensures all sites test
the intervention and evaluate sustainability and impact of the new model.
Clinical setting: Standards for usual care within the hospital includes screening for
malnutrition risk by nursing or other non-RDN staff, 14 within 24 hours of admission. A
positive screening elicits a consultation with an RDN who conducts a comprehensive assessment
to determine whether a nutrition problem, such as malnutrition, exists. The RDN will then
provide nutrition care to patients for the duration of their hospital stay. The nutrition
care is documented in the hospital's electronic health record (EHR) and includes
anthropometric and laboratory data in addition to the nutrition problem and care plan.For the
new model of care, the data collection tool (ANDHII) will be modified to use the HL7® FHIR
standard to import (pull) data from acute care hospital EHRs. The data will then be available
via ANDHII for the community RDN to use.
Community setting: Within our new model of continuity of nutrition care, an RDN within the
meal provision organization (Title III-C1 and 2) will log into ANDHII and accept the referral
and subsequent data sent by the clinical RDN. The community RDN will review the data and the
discharge nutrition care plan before visiting with the patient within their home or at the
congregate meal center. At the initial community visit (home visit or congregate meal site),
the community RDN will reassess the person for malnutrition and adjust the nutrition care
plan as needed for the home/community environment and the patient's social, functional, and
economic circumstances. The aim within the community setting will be for the community RDN to
have three subsequent visits, approximately a month apart, for three months post-discharge
from the hospital. A dedicated Research RDN at each site will conduct the malnutrition, food
security, and QOL tools at baseline and again at the end of month three post-discharge for
all the enrolled patients, regardless of whether they are in the control or intervention
period.
