Occupational Therapy and Dietitian Services for Reducing Falls

Overseen By Lisa A Juckett, PhD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Receiving meals, Residential care, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to reduce the risk of falls for people receiving home-delivered meals. Participants will be divided into four groups to test different combinations of services: meals alone, meals with dietitian support, meals with occupational therapy, and meals with both dietitian and occupational therapy. The focus is on improving safety and nutrition for those who can't easily leave their homes. Suitable candidates for this trial are individuals over 60 who have difficulty leaving home safely, live in the specified service area, and can store and reheat frozen meals.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance safety and nutrition for homebound individuals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these service models are safe for reducing fall risk?

Research has shown that adding registered dietitian (RD) and occupational therapy (OT) services to home-delivered meal programs can help reduce the risk of falls. In a previous study, these services were combined to assess their impact on reducing falls among older adults receiving meal deliveries. The study found potential benefits without major safety concerns.

Specifically, studies on RD services have not reported serious negative effects. These services typically include nutrition assessments and education, which are generally safe. Similarly, OT services aimed at preventing falls have improved balance and safety without major safety issues. In one case, individuals who received OT services experienced fewer falls than those who did not.

These findings suggest that both RD and OT services are safe and can be effectively integrated into meal programs for older adults. Participants have not reported significant negative effects from these services, making them a safe option for reducing fall risks at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique combination of services aimed at reducing falls, specifically using occupational therapy (OT) and registered dietitian (RD) services alongside meal delivery. Unlike standard fall prevention methods that might focus solely on physical therapy or home modifications, this approach integrates personalized nutrition guidance and home safety assessments to address fall risks comprehensively. The trial's innovative method combines targeted dietary advice for managing health conditions like diabetes and cardiovascular disease with home safety evaluations to identify and mitigate fall hazards. By offering a holistic approach, this trial has the potential to uncover more effective strategies for preventing falls, particularly for individuals managing multiple health conditions.

What evidence suggests that this trial's treatments could be effective for reducing fall risk?

Research has shown that occupational therapy can significantly help older adults improve their balance and reduce their fear of falling. Studies found a 48% reduction in falls requiring medical care when occupational therapy was involved. Assistance from registered dietitians, particularly in increasing dairy intake, has been linked to fewer falls. In this trial, participants will be assigned to different arms to evaluate the effectiveness of these services. One arm will receive meals only, another will receive meals plus registered dietitian services, a third will receive meals plus occupational therapy services, and a final arm will combine both dietitian and occupational therapy services with home-delivered meals. These findings suggest that using these services together can effectively lower the risk of falls in older adults. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for home-delivered meal clients who may be frail, have diabetes, weakness, cardiovascular disease or functional disability. It aims to find the best service model to reduce fall risk among these individuals.

Inclusion Criteria

Lives within LifeCare Alliance's 5-county service area

Has a working freezer to store between 7-14 frozen meals/week

Has a working microwave or oven to reheat meals

Exclusion Criteria

Individuals residing in residential care or a skilled nursing facility

Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection

Unable to independently answer LifeCare Alliance's in-take questions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive meals and various combinations of registered dietitian and occupational therapy services for 3 months

12 weeks

Weekly meal deliveries, phone assessments by dietitians and occupational therapists

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Occupational Therapy and Registered Dietitian Services

Trial Overview

The study is testing four different combinations of services: meals alone; meals with dietitian (RD) services; meals with occupational therapy (OT); and meals with both RD and OT services to see which reduces fall risks most effectively.

How Is the Trial Designed?

Group I: Arm 1: Meals only Active Control 1 Intervention

ARM 1: Meals only. Participants randomized to receive "meals only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 42 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards.

Group II: Arm 2: Meals + RD services Active Control 1 Intervention

ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment.

Group III: Meals + OT services Active Control 1 Intervention

ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment).

Group IV: Arm 4: Meals + RD + OT services Active Control 1 Intervention

ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

LifeCare Alliance

Collaborator

Trials

2

Recruited

810+

Published Research Related to This Trial

The employment of a part-time dietetic technician (D.T.) significantly improved the efficiency of the registered dietitian (R.D.) in a burn unit, as evidenced by an increase in the percentage of nutrition information charted and recommendations made for nutrition support from year 1 to year 2.

While the study showed that the R.D. was able to document more nutrition recommendations with the D.T.'s assistance, there was not enough data to assess the direct impact of this team on the nutritional status of burn patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the dietitian-technician team on a burn unit. Ptak, KM., Egenmaier, MC., Godfrey, LB., et al.[2018]

The study emphasizes the need for a collaborative approach between dietitians and speech therapists to improve swallowing training for elderly patients with oropharyngeal dysphagia in long-term care facilities.

By implementing a structured care model that includes specific protocols for swallowing training and dietary adjustments, the study aims to enhance the effectiveness of interventions, ultimately improving the quality of life for patients and meeting the expectations of their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interprofessional Collaborative Practice in Long-Term Care: Swallow Training]. Liang, FC., Cho, MH.[2022]

The geriatric consultation team at Massachusetts General Hospital, established in 1980, provides comprehensive care for elderly patients, addressing their complex medical, psychological, and social needs to help them regain independence.

The multidisciplinary approach, including nutritional screening and collaboration among health professionals, has led to earlier identification of patient needs, more personalized care plans, and a reduction in hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric team dynamics: the dietitian's role. Delahanty, LM.[2008]

Collaboration with dietitians in functional rehabilitation services helps prevent recidivism and supports patients in regaining independence.

A coordinated care approach involving dietitians has shown benefits for patients with various conditions that lead to functional impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nurse and dietitian: effective collaboration in rehabilitation]. Poindessous, JL., Basta, M., Renaud, A., et al.[2018]

A study of 117 malnourished older inpatients showed that multidisciplinary oral health management by a nutrition support team significantly improved their nutrition-intake methods and oral health, as indicated by better scores on the Functional Oral Intake Scale (FOIS), Dysphagia Severity Scale (DSS), and Oral Health Assessment Tool (OHAT).

The improvements in nutrition intake were positively correlated with the length of the intervention, suggesting that longer NST involvement leads to better outcomes in both nutrition intake and oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Nutrition-Intake Method and Oral Health through a Multidisciplinary Team Approach in Malnourished Older Patients Admitted to an Acute Care Hospital. Suzuki, H., Furuya, J., Nakagawa, K., et al.[2023]

A study involving 124 healthcare professionals (87 dietitians and 37 dietitian assistants) across eight hospitals in Queensland, Australia, revealed that dietitians felt there were inadequate guidelines for delegating malnutrition care activities, with less than 50% agreement on key areas like assessment and care coordination.

Despite dietitian assistants feeling adequately prepared for certain delegated tasks, the actual practice showed that dietitians routinely performed most nutrition care activities, indicating a need for clearer delegation processes and guidelines to enhance nutrition care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delegation Opportunities for Malnutrition Care Activities to Dietitian Assistants-Findings of a Multi-Site Survey. Rushton, A., Young, A., Keller, H., et al.[2021]

A nutritional rehabilitation program for individuals with severe developmental disabilities successfully met weight management goals for residents in a long-term care facility over 6 months, with individualized menus created by a dietitian.

The program demonstrated that effective nutritional management can be achieved without increasing food quantity, highlighting the importance of dietitian involvement in enhancing the health of these residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nutritional rehabilitation program for persons with severe physical and developmental disabilities. Hogan, SE., Evers, SE.[2017]

Consultant dietitians in nursing homes play a crucial role in improving nutrition through menu planning, dietary consultations, and staff training, which are essential for resident health.

Administrators noted that the most significant impact of these consultants was in modifying diets and enhancing communication between foodservice and other departments, leading to better overall food safety and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The consultant dietitian in nursing homes. II. Functions and change effectiveness. Spear, DM., Vaden, AG., Spears, MC.[2007]

The study found that compliance with key nutritional support standards was low, with only 46% adherence to one standard and 82% to another, indicating significant gaps in the management of malnutrition among community-dwelling adults.

Despite high patient satisfaction (86%) with the community prescribing support service, the overall findings suggest a need for quality improvement initiatives to enhance the identification and management of malnutrition, as current practices vary widely among dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research identified variation in nutrition practice by community prescribing dietitians with regards to the identification and management of malnutrition amongst community dwelling adults. Allmark, G., Calder, PC., Marino, LV.[2021]

Registered dietitian nutritionists (RDNs) and nutrition and dietetics technicians, registered (NDTRs) are crucial for providing nutrition services to individuals with intellectual and developmental disabilities (IDD) and children and youth with special health care needs (CYSHCN), addressing various health risks and nutritional challenges throughout their lives.

Timely nutrition interventions by RDNs and NDTRs can significantly promote health maintenance and reduce the risk of comorbidities, highlighting the importance of their role in community-based care for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the Academy of Nutrition and Dietetics: nutrition services for individuals with intellectual and developmental disabilities and special health care needs. Ptomey, LT., Wittenbrook, W.[2022]

Registered dietitians (RDs) and dietetic technicians, registered (DTRs) play a crucial role in providing nutrition services for individuals with developmental disabilities and special health care needs, addressing various nutrition-related concerns throughout their lives.

Timely and effective nutrition interventions can help manage health risks and promote better health outcomes, highlighting the importance of RDs and DTRs in improving the quality of life for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: Providing nutrition services for people with developmental disabilities and special health care needs. Van Riper, CL., Wallace, LS.[2019]

After allowing registered dietitians (RDs) to enter nutrition-related orders directly, error rates decreased by 15%, indicating improved patient safety.

The time delays for processing these orders were reduced by 39%, demonstrating that RDs can enhance the efficiency of nonmedication order entries in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet order entry by registered dietitians results in a reduction in error rates and time delays compared with other health professionals. Imfeld, K., Keith, M., Stoyanoff, L., et al.[2018]

Older adults should have access to evidence-based food and nutrition programs to ensure they receive safe and adequate food, which is essential for promoting optimal health, functionality, and quality of life.

Registered dietitian nutritionists and nutrition technicians should collaborate with other health professionals to create coordinated services that include nutritional screening, education, and monitoring, which are crucial for managing chronic diseases and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the Academy of Nutrition and Dietetics and the Society for Nutrition Education and Behavior: Food and Nutrition Programs for Community-Residing Older Adults. Saffel-Shrier, S., Johnson, MA., Francis, SL.[2020]

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