Essential Connections: Hospital to Community Impacting Malnutrition Outcomes in Older Adults

NCT05893446 | Not Yet Recruiting

• 1 other identifier: 95INNU0045
• Study Type: interventional
• Target: 1,120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malnutrition; Protein

Outcome Measures

Primary Outcomes (1)

• Quality of Life Scale (CASP-19)

  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.

  3 months

Secondary Outcomes (6)

• Program Sustainability Assessment Tool

  Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4

• 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

• Food Security Risk

  3 months post discharge from the hospital

• Malnutrition risk

  baseline in hospital and at 3 months post discharge from the hospital

Interventions

Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms. DIETARY_SUPPLEMENT

RDNs in the community will provide MNT and meals for three months post discharge from the hospital

Also known as: Meals

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead
• University of New Mexico: collaborator
• Hartford Hospital: collaborator
• Meals on Wheels Central Texas: collaborator

MeSH Terms

Conditions

Kwashiorkor

Interventions

Meals

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alison L Steiber

  Academy of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Woodstock, PhD

CONTACT

3128994797; lwoodstock@eatright.org

Constantina Papoutsakis, PhD

CONTACT

3128994721; cpapoutsakis@eatright.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Model Details: Patient enrollment and data collection will begin in year two. In year one, sites will have been randomized to the intervention condition within four sequence blocks on a staggered schedule. The stepped wedge cluster-randomized trial design will go through 5 periods with each period lasting for 7 months for a total of 35 months (year 2 through year 4). The goal of year two is for all sites to initiate the schedule to which they are randomly assigned. All participating sites will start in the control condition (usual process/care) in period 1. By the end of year two, we aim for sites to be within period 2. At this time, two sites will be implementing the intervention. Patients will be recruited and enrolled from acute care hospital sites in a rolling fashion across the entire study period (year 2 to year 4).

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 8, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share