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Recruiting NCT04445883

Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Medical Rehab Patients at Joseph Brant Hospital

No phase Interventional Food Intake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Feeding Assistance.
Who it may be relevant to
Registry conditions: Food Intake. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating the Impact of a Volunteer Based Mealtime Assistance Program on the Nutritional Status of Patients at Joseph Brant Hospital in Ontario, Canada

Overview

This research study will determine the impact of the Eating Matters Program on the nutritional status of elderly patients at Joseph Brant Hospital. The Eating Matters Program at Joseph Brant Hospital is a volunteer-based feeding assistance program that aims to improve patients' nutritional intake by providing assistance during mealtimes. As research on the impact of such programs on food intake is limited in Canada, this study will explore how the Eating Matters Program influences protein and energy intake of patients at Joseph Brant Hospital. Further, this study will explore if the hypothesized increase in protein and energy intake with the initiation of the Eating Matters Program is correlated with a decreased risk of malnutrition.

Detailed description

We will be conducting a prospective open-label non-randomized controlled trial to evaluate patients' nutritional outcomes in units that have the Eating Matters Program available (Study Group A) vs. similar units that do not have this program (Control Group B), as this can provide useful data on the effectiveness of such programs in developing innovative prevention strategies to address hospital malnutrition.

A total sample size of eighty participants (40 in each group) will be included in this study from Medical and Rehabilitation units at Joseph Brant Hospital. Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. Baseline food intake data (including breakfast, lunch and dinner) will be gathered during a 2-day period for both Study Group A and Control Group B. Following the collection of baseline data, feeding assistance will then be provided to participants in the units that have the EMP program available (6S100 and 6N400/500). In addition, food intake will be recorded for a total of 6 days for both Study Group A, and Control Group B. Outcome measures including C-reactive protein and weight will be measured weekly. Following, a Subjective Global Assessment (SGA) will be completed and Hand Grip Strength will be recorded on days 1 and 18 as the literature shows that this is an appropriate timeframe to reassess these measures (Flood et al., 2014; Canadian Malnutrition Task Force, 2019). Energy and protein intake will then be calculated using visual estimation by completion of the My Meal Intake Tool, and the hospital's CBORD software. Further, to evaluate the success of the feeding assistance program, volunteers will distribute the feedback survey to patients, staff, family members or friends of participants. To prevent contamination from staff working on both sides, members of the research team will have a discussion with staff to explain that the study and potential benefits should not be discussed, as this may impact the research findings.

Interventions

  • Behavioral Feeding Assistance
    Patients will be receiving assistance during mealtimes. This includes assistance by opening packages, listing/explaining the food products on the tray, providing encouragement and companionship during mealtimes and directly feed patients.

Primary outcome measures

  • Dietary Intake [Time frame: To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).]

Eligibility criteria

Inclusion criteria

  • Patients 65 years and over admitted to Medicine and Rehabilitation units at Joseph Brant Hospital with an anticipated stay 10-14 days
  • Patients with a Subjective Global Assessment score of B or C, and identified to require eating assistance
  • Patients able to provide consent or have a Power of Attorney to do so on their behalf

Exclusion criteria

  • Patients that are NPO status (nothing by mouth)
  • Patients that require enteral or total parenteral feeding
  • Palliative care patients
  • Severe cognitive impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • Joseph Brant Hospital — Burlington

Publications

  • Allard JP, Keller H, Teterina A, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Lou W. Lower handgrip strength at discharge from acute care hospitals is associated with 30-day readmission: A prospective cohort study. Clin Nutr. 2016 Dec;35(6):1535-1542. doi: 10.1016/j.clnu.2016.04.008. Epub 2016 Apr 13. PMID 27155939
  • Allard JP, Keller H, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Teterina A, Lou W. Decline in nutritional status is associated with prolonged length of stay in hospitalized patients admitted for 7 days or more: A prospective cohort study. Clin Nutr. 2016 Feb;35(1):144-152. doi: 10.1016/j.clnu.2015.01.009. Epub 2015 Jan 21. PMID 25660316
  • Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16. PMID 21556200
  • Bharadwaj S, Ginoya S, Tandon P, Gohel TD, Guirguis J, Vallabh H, Jevenn A, Hanouneh I. Malnutrition: laboratory markers vs nutritional assessment. Gastroenterol Rep (Oxf). 2016 Nov;4(4):272-280. doi: 10.1093/gastro/gow013. Epub 2016 May 11. PMID 27174435
  • Curtis LJ, Valaitis R, Laur C, McNicholl T, Nasser R, Keller H. Low food intake in hospital: patient, institutional, and clinical factors. Appl Physiol Nutr Metab. 2018 Dec;43(12):1239-1246. doi: 10.1139/apnm-2018-0064. Epub 2018 May 8. PMID 29738268
  • Curtis LJ, Bernier P, Jeejeebhoy K, Allard J, Duerksen D, Gramlich L, Laporte M, Keller HH. Costs of hospital malnutrition. Clin Nutr. 2017 Oct;36(5):1391-1396. doi: 10.1016/j.clnu.2016.09.009. Epub 2016 Sep 19. PMID 27765524
  • Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available. PMID 30301744
  • Edwards D, Carrier J, Hopkinson J. Assistance at mealtimes in hospital settings and rehabilitation units for patients (>65years) from the perspective of patients, families and healthcare professionals: A mixed methods systematic review. Int J Nurs Stud. 2017 Apr;69:100-118. doi: 10.1016/j.ijnurstu.2017.01.013. Epub 2017 Jan 30. PMID 28199923

Identifiers

NCT: NCT04445883 · JosephBrantH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗