Clinical trial NCT04445883: Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Medical Rehab Patients at Joseph Brant Hospital
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Intake
Lead sponsor: Joseph Brant Hospital
Sponsor class: OTHER
Collaborators: name: Western University
First posted: 2020-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will be evaluating patients' nutritional outcomes in units that have the Eating Matters Program available vs. similar units that do not have this program. Therefore, there will be two groups, Study Group A and Control Group B.
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Dietary Intake
timeFrame: To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).
Secondary outcomes:
Other outcomes:
measure: Percent weight change
timeFrame: A change from baseline body weight at 1 week and 2 weeks marks (+/-2) days post the initiation of the Eating Matters Program (EMP).
measure: Handgrip strength
timeFrame: A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP.
measure: C-Reactive Protein
timeFrame: A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP.
measure: Eating Matters Program Feedback
timeFrame: This will be measured on day 19 (+/-2 days) (total study period for each participant).
measure: Length of stay
timeFrame: This data will be gathered on day 120 (+/-2days), upon completion of the study.
measure: Mortality rate
timeFrame: This data will be gathered on day 120 (+/- 2days), upon completion of the study.
measure: Re-admission rate
timeFrame: This data will be gathered on day 120 (+/- 2 days), upon completion of the study.
Locations:
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Latifa Ahmadi, PhD
role: STUDY_CHAIR
References:
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