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MCGILL UNIVERSITY
Medication Pass Pilot Project
Final Report
Miriam Tabet
Student ID: #260376011
Monday August 4th
, 2014
2
ABSTRACT
Elderly are at increased risk of malnutrition, due to cognitive impairment, depression, social isolation,
polypharmacy, multiple comorbidities, etc. This partly explains why it is estimated that 35% to 85% of
long-term care residents are malnourished. Traditional oral nutrition supplementation has been
associated increased non-consumption of supplements and therefore suboptimal impact on nutrition
management. Therefore, the MedPass pilot project is a new patient-centered approach to prevent
malnutrition and the consequences of malnutrition in elderly. The MedPass project takes place at Henri-
Bradet long-term care residence, for 12 weeks. Nineteen participants were recruited for maintenances or
restoration of adequate nutritional status. The implementation of the project involves distribution of 60
ml of a high-energy, high-protein nutritional supplement (Resource 2.0), 4 times per day, by nurses, with
the medication rounds. The MedPass treatment appeared to be beneficial for malnutrition, principally
because of the residents full consumption of the energy- and protein-dense supplement. For the majority
of participants, the results indicated a positive impact on weight change and BMI, as well as
improvement of nutritional status, reflected in the upward shift of the MNA screening score. The project
indicated that MedPass would have a potential cost saving element in health care institutions.
3
I. INTRODUCTION
Elderly individuals are at increased risk of malnutrition, due to their greater risk of cognitive
impairment, depression, social isolation, polypharmacy and multiple comorbidities. The etiology of
malnutrition is multifactorial and despite efforts to remain independent, many elderly are admitted to
nursing homes, therefore exacerbating their malnutrition risk. It is estimated that the prevalence of
malnutrition in the long-term care setting ranges from 35 to 85% (Greene Burger, Kayser-Jones, &
Prince, 2000; Keller, 1993; Laporte, Villalon, & Payette, 2001; Nutrition Screening Initiative, 2002).
Malnutrition, defined by Saunders, Smith and Stroud (2010) as a "deficiency, excess or imbalance of a
wide range of nutrients, resulting in measurable adverse effects on body composition, function and
clinical outcome", is known to be one of the most relevant conditions that negatively affects the health
of elderly population (Norman, Pichard, Lochs, & Pirlich, 2008).
In order to resolve the issue of clinical protein-energy malnutrition, the Medication Pass Nutritional
Supplement Program was introduced in 1996 by Kerrigan, Maxwell and Siegel, later termed Med Pass
program. This approach involves the distribution of low-volumes (60 mL or 90 mL) of a high-calorie,
high-protein nutritional supplement, three to four times a day with medications. This method aims to
prevent any disruption of appetite and is well tolerated by volume-sensitive individuals (Dillabough,
Mammel, & Yee, 2011). It has been associated with high patient compliance, optimized clinical
benefits, reduced product wastage and lower costs (Strange et al., 2013).
The purpose of this study is to determine if the implementation of the Med Pass project at Henri-Bradet
Residential Center would be an effective method for the treatment of malnutrition in elderly patients.
The pilot study has two principal objectives; to evaluate the effects of the Med Pass program on
4
residents' nutritional status through MNA (Malnutrition Nutritional Assessment) score and body weight,
and evaluate the supplement waste-associated costs.
II. MATERIALS AND METHODS
1. Setting and participants
This 3-month pilot study was conducted at a 125-bed long-term care facility in Montreal. Preliminary
work for the Med Pass pilot project began in January 2014, while the study duration was from February
to May 2014. A total of 19 residents were selected to participate in the study. Baseline selection criteria
required all residents to be at least 65 years old, and to be initially receiving traditional oral liquid
supplements. To determine eligibility for study participation, residents were screened at baseline, within
1 week interval, using the short-form of the Mini Nutritional Assessment (MNA) tool (Appendix 1), and
only those screened as malnourished or at risk of malnutrition were selected.
The study eligibility criteria are as follows: residents must be at least 65 years old, not dysphagic, taking
oral supplements, have a MNA score of ≤11 and able to provide consent. Study exclusion criteria
included residents with adequate nutritional status, dysphagic residents on modified honey or pudding
liquid consistency, and cognitively impaired individuals who could not provide consent. To meet
regulations of the Ethics Committee of Research of CSSS Cavendish, all the pilot project participants
personally gave free and informed verbal consent for study participation.
While the 3-month pilot project was taking place, along with data collection of the selected participants,
the Med Pass program was running throughout the whole Center, so that all residents assessed by the
medical team as benefiting from Med Pass would receive the proper nutritional treatment. This report
addresses the methodology and findings only pertaining to the 3-month pilot project and its selected
participants.
5
2. Measurements
Weights of the residents participating in the pilot project were taken at baseline and monthly by nurses,
using the same calibrated balance, from which percent weight change and body mass index (BMI) were
calculated. Participants were reweighed if there was a difference of 3 kg or more from the previous
month's weight. The MNA tool was conducted at baseline and at project end. Resident adherence to the
Med Pass supplement was quantified by a review of medical chart documentation on the medication
administration record (MAR) sheet. Nurses documented whether the residents were consuming 1/4, 1/2,
3/4, or all of Med Pass supplements, distributed with medications, four times per day (Appendix 2). The
pharmacist reviewed each participating resident's medication profile for potential food-drug interaction,
and none were found. Since Med Pass supplements replaced traditional oral supplements, there was no
need to assess the participants' consumption of the latter. Finally, mid-way staff perception was assessed
at week 6, using a non-validated evaluation survey that determined continuation or cessation of the Med
Pass pilot project.
3. Procedure and implementation
The implementation of the pilot project started in January 2014. Once the Med Pass project was
presented to the public and to the multidisciplinary team of the center, the protocol was officially
launched on February 2014, using an energy-dense and protein-dense nutritional supplement called
Resource 2.0. This product was already available at the facility, in the 946 mL bottle format, providing 2
kcal/mL and 0.08 g protein/mL, and is suitable for diabetic patients, as well as those with regular and
nectar liquid consistency. The nurses provided 60 ml of Resource 2.0 with medications, four times per
day thus providing 480 kcal/day and 20 g protein/day and 25% of the recommended intake of vitamins
and minerals in addition to their normal food intake. Resource 2.0 (946 mL bottle format) costs 1.37$.
6
During the pilot study, other supplements were discontinued and replaced with Resource 2.0, while
actual high-energy, high-protein foods continued as is.
III. RESULTS
1. Participants characteristics
From the initial 19 residents eligible for project participation, only 15 completed the study since 1 was
discharged and 3 were discontinued for project abandon; from which 2 changed their mind about their
consent regarding study participation (each after 1 week and 4 weeks), while 1 other refused to continue
gaining more weight after 8 weeks of study participation. The results presented are for the 15 residents
who completed the 3-month pilot study period. Statistical analysis was calculated using SAS 9.4
software and paired t-test were performed in order to assess the significance in change of weight. The
sample size was composed of 5 men and 10 women, with a mean age of 86.7 years old (SD 7.0; age
range 67 to 96). The results from the initial MNA screening tool revealed that 7 out of 15 residents were
at risk for malnutrition and 8 were already malnourished, with a mean MNA score of 7.7 points (SD
2.4). Using the BMI classification suggested by the "Guide Pratique d'Évaluation de l'État Nutritionnel"
(Boivin, Gélinas, Lacroix, Maltais, Lavandier, & Morin, 1993), where normal BMI range for 65-80
years old is 20-27 kg/m2
, and normal BMI for 80+ years old is 20-29 kg/m2
, it was found that 10 out of
15 residents were underweight and 5 were of normal weight, with an overall mean BMI of 20.3 kg/m2
(SD 3.8), equivalent to the lower range of normal BMI classification.
2. Weight change
During the pilot study period, 11 out of 15 residents (73%) made positive weight gains while only 4
(27%) lost weight, for an average weight change of +1.2 kg, calculated as +2.2% (p < 0.05) of initial
weight. As per the Omnibus Budget Reconciliation Act of 1987, significant weight gain is 5% of body
7
weight in 30 days, 7.5% in 60 days, or 10% in 180 days. From the residents who experienced weight
gain, the average weight gain was significant, being 2.2 kg (+4.1%; p = 0.05) in 3 months.
In May, two participants (E and H) refused to be weighted. The total weight change and calculated
percent of weight change are represented for a shorter period of time, 2 months, based on the last weight
available in April. As depicted by Graph 1 below, weight gain of the participants is more prevalent than
weight loss, since 11 of 15 participants experienced weight gain, and only 4 lost weight.
Graph 1
Percentage of weight change (%) per participant in 3-month period.
4. MNA score
The results from the initial MNA screening tool revealed that 7 out of 15 residents at risk for
malnutrition and 8 were already malnourished, with a mean MNA score of 7.7 points. Final MNA score
reassessment after the 3-month period revealed a significantly higher mean score of 9.0 points (p <
0.05). In parallel with the primary study objectives concerning change in body weight, this study
8
examined changes for the two weight-related questions scores that could possibly be influenced by Med
Pass supplementation. During the duration of the pilot study period, Question B ("weight loss during the
last 3 months") had a mean score increase from baseline 2.4 (SD 1.0) to 2.6 (SD 0.8), still classifying the
findings between the same answer categories 2-weight loss between 1 and 3 kg and 3-no weight loss (p >
0.05) . While Question F1 ("BMI kg/m2
") also had a mean score increase from 1.3 (SD 1.3) to 1.5 (SD
1.3), still classifying the final score between 1-BMI 19 to less than 21 and 2-BMI 21 to less than 23
answers (p > 0.05). The change in each participant's MNA score results (total score, question B score
and question F1 score) is summarized in Graph 2 below.
Graph 2
Participants' baseline and final total MNA score, Question B MNA score and Question F1 MNA
score (points)
5. Supplement costs
Since the amount of calories and protein vary per nutritional product, it is necessary to compare the price
per 1000 kcal and per 1g protein, for accurate between-product cost comparison. See Table 1 below for
a visual comparison between 235-237 mL format supplements of Resource 2.0 (used for Med Pass
9
program), Ensure regular and Ensure Plus. Calculations demonstrate that the cost of Resource 2.0 per
mL is slightly more than Ensure Plus but it is also slightly less than the other frequently used product,
Ensure regular. As part of the Med Pass project, the dietary department is only providing the large (946
mL) Resource 2.0 format to the floors for an enhanced ease of use for the nursing staff. As demonstrated
in Table 6 below, the purchase cost per 1000 kcal and per 1 g protein of this large 946 mL format is
significantly more expensive than any other smaller supplement format. More specifically, compared to
the smaller format (237 mL) of the same product, the large Resource 2.0 format is 35% more expensive
per 1000 kcal and 88% more expensive per 1g protein.
Table 1
Price comparison per 1000 kcal and per 1g protein, for nutritional supplements Resource 2.0,
Ensure regular and Ensure Plus
Table 2 and Graph 3 below summarize the monetary impact of the Med Pass program on total
supplements cost, including Med Pass and non-Med Pass supplement use. There was a 30% decrease in
total supplement cost for the 3-month study duration, despite the gradual increase then stabilisation of
Product Price per
case
Price per
format
Cal /
format
Protein/
format
Price per
1000 kcal
Price per 1g of
protein
Ensure regular (case of 24
bottles of 235 ml)
11,62$ 0,484$ 250 Cal 9,4 g 1,94$ 0.050$
Ensure Plus (case of 24
bottles of 235 ml)
13,51$ 0,563$ 355 Cal 13,5 g 1,58$ 0.041$
Resource 2.0 (case of 27
tetras of 237 ml)
24,26$ 0,90$ 480 Cal 20 g 1,88$ 0.045$
Resource 2.0 (case of 12
tetras of 946 ml)
65,70$ 5,46$ 1915 Cal 80 g 2.9$ 0.373$
10
Resource 2.0 supplement use. This shifting in supplement costs was due to the significant 44% decrease
in non-Med Pass supplement use (Boost, Ensure, Boost diabetic, Glucerna, Novasource Renal, etc.) that
were gradually substituted by Resource 2.0 supplements, throughout the Center.
Table 2
Monthly cost (February to May 2014) of total supplements, non-Med Pass supplements and
Resource 2.0, as well as total percentage change
Graph 3
Baseline and final cost (February and May 2014) of total supplements, non-Med Pass supplements
and Resource 2.0
6. Participants adherence
Compliance to Med Pass was high. From the 15 residents included in the pilot project, all were 100%
compliant.
11
7. Nursing staff perception
The non-validated mid-way evaluation form was completed by a total of 9 nursing employees at the
Henri-Bradet centre. Results demonstrate that 88.9% of respondents affirmed that they strongly
agree/agree that passing out Resource 2.0 to residents (Question 1) and that documenting resident’s
intake on the MAR sheet (Question 2) is simple. Respectively, 87.5% and 71.4% of respondents
strongly agree/agree that compliance for intake of Resource 2.0 is good (Question 3) and that there is
less non-Med Pass supplement use (Question 4). Finally, 85.7% of respondents strongly agree/agree that
residents taking Resource 2.0 appear to have an improved health status (Question 5), and 88.9% said
that the med Pass Program is beneficial and should be continued (Question 6).
IV. DISCUSSION
The 3-month Med Pass program had a positive impact on the weight of the subjects, but not as clinically
significant as expected, based on the promising findings of previous literature assessing the impact of
Med Pass on anthropometrical nutritional markers (Kerrigan, Maxwell, & Siegel, 1996; Lewis, &
Moyle, 1998; Dillabough, Mammel, & Yee, 2011; Welch, Porter, & Endres, 2003; Doll-Shankaruk,
Yau, & Oelke, 2008; Remsburg, Sobel, Cohen, Koch, & Radu, 2001; Jukkola, & MacLennan, 2005;
Strange et al., 2013). Although weight gains were statistically significant (p < 0.05) and occurred for
most of the subjects, they were smaller than expected. For the participants' weight gain to be significant
and within the guidelines of the Budget Reconciliation Act of 1987, this would have required the
residents to meet their nutritional needs consuming the meals provided, with the additional Med Pass
supplemental calories for intended weight gain. Resource 2.0 fully consumed (60 ml four times/day),
theoretically translates to a gain of 0.44 kg (0.96 lbs) per week. One could speculate that the participants
who consumed the totality of the supplements ate less than their nutritional needs through food, on most
study days. The residents who lost weight were known to be eating very little food for various reasons.
12
Among residents taking Resource 2.0, greater weight loss may have occurred due to poor nutritional
intake had they not had the supplement. This knowledge-based assumption would need to be validated
by assessing the amount of food and calories daily ingested by the participants.
The Med Pass program had a significant (p < 0.05) positive impact on the MNA short-form result
scores, since the initial mean MNA score upgraded from 7.7 points (SD 2.4), to the final MNA score of
9.0 points (SD 2.3). The increase in mean MNA scores revealed that after the 3-month period, the pilot
project participants went from the "malnourished" classification (higher range) to the "at risk of
malnutrition" (lower range), indicating a clinically significant improvement in malnutrition status
despite the short period of study time. The score change of two MNA short-form questions pertaining to
weight change, respectively Question B ("weight loss during the last 3 months") and Question F1 ("BMI
kg/m2
"), an increase in mean score was also noted from 2.4 (SD 1.0) to 2.6 (SD 0.8), as well as from 1.3
(SD 1.3) to 1.5 (SD 1.3). Even though an increase in mean score of those two specific questions was
observed, this was not clinically significant within the 3-month period of time, since it still classifies the
findings between the same answer categories, respectively 2-weight loss between 1 and 3 kg and 3-no
weight loss and 1-BMI 19 to less than 21 and 2-BMI 21 to less than 23. Since the MNA short-form
assessment comprises data on anthropometry, dietary assessment and general assessment it is believed
that the results observed would have been more significant in a longer than 3-month study period of
time.
Compliance on the Med Pass system was high. The cost of Resource 2.0 per ml is slightly more than
some of the other supplements, but it is also slightly less than one of the most frequently used products
(Ensure regular). The traditional supplement are known to go to waste compare to the Med Pass system.
This explains why the monthly cost of total supplements went down to attain a 30% decrease within the
13
3-month pilot project. In Table 7, the Med Pass supplement (Resource 2.0) cost has been fluctuating,
depicting the adjustments in quantity ordered and purchased throughout the establishment.
The hypothesis of the residents' adherence, is due to the supplement being distributed in small
quantities (60ml) between meals. Also, Resource 2.0 was perceived by the residents as a medical
treatment which could explain the totality of amount ingested. It’s possible that residents are more
compliant to a perceived medical therapy versus a dietary supplement provided in its container and
served with meals.
As demonstrated by the mid-way evaluation, the nurses seemed pleased with the Med Pass program.
Most importantly, 88.9% of respondents said that the program is beneficial and should be continued
(Question 6 of the mid-way evaluation form). The nurses did not perceive the program as an increase of
workload, but welcomed it as a new tool for the treatment and prevention of malnutrition, even if it
required extra nursing time. The positive outcome of the mid-way questionnaire decided that the project
should continue until the 12th
week.
The baseline MNA nutritional screening permitted validation of the previously documented severity of
the issue of malnutrition in elderly living in long-term care facilities (Greene Burger, Kayser-Jones, &
Prince, 2000; Keller, 1993; Laporte, Villalon, & Payette, 2001; Nutrition Screening Initiative, 2002),
which stresses the importance of nutritional management. However, the studied sample was not
representative of the Henri-Bradet Residential Center's total population. First, due to the small sample
size (n= 15) and second, because inclusion criteria comprised non-severely cognitively impaired
residents, and residents on regular and nectar liquid consistency, while literature demonstrated that
elderly with cognitive impairment or with dysphagia are at increased risk of malnutrition (Ministère de
Santé et de Services sociaux du Québec, 2011).
14
V. CONCLUSION
The Med Pass treatment appeared to be beneficial in treating malnutrition. For the majority of
participants, the results indicated a positive impact on weight change. The pilot project indicated that
Med Pass would have a potential cost saving element in health care institutions.
This pilot project is relevant to clinical nutrition as it offers an alternative to low-compliance and
suboptimal nutritional impact associated to traditional nutritional supplementation. It is believed that the
Med Pass program, offered in conjunction with a high quality menu, would be a patient-centered and
cost-effective approach for the management and treatment of malnutrition.
15
REFERENCES
Chevalier, S., Desjardins, I., & Mainville, D. (2008). Dépistage de la dénutrition et impact d'une
intervention nutritionnelle chez les personnes âgées en soins de longue durées. Nutrition: science
en évolution, 6(1), 17-20.
Chumlea, W. C., Roche, A. F., & Steinbaugh, M.L. (1985). Estimating stature from knee height for
persons 60 to 90 years of age. Journal of the American Geriatrics Society, 33(2), 116-20.
Comité des diététistes en évaluation nutritionnelle gériatrique (1993). Guide Pratique D'Évaluation de
l'État Nutritionnel. Canada, Québec: Boivin, D., Gélinas, M. D., Lacroi, G., Maltais, M.,
Lavandier, L. M., & Morin, A.
Constans, T., Bacq, Y., Brechot, J., Guilmot, J., Choutet, P., & Lamide, F. (1992). Protein energy
malnutrition in elderly medical patients. Journal of the American Geriatrics Society, 40, 263-
268.
Covinsky, K., Martin, G., Beyth, R., Justice, A., Seghal, A., Landefeld, C. (1999). The relationship
between clinical assessments of nutritional status and adverse outcomes in older hospitalized
medical patients. Journal of the American Geriatrics Society, 47, 532-538.
Dillabough, A., Mammel, J., & Yee, J. (2011). Improving nutritional intake in post-operative hip
fracture patients: A quality improvement project. Journal of Orthopedic and Trauma Nursing,
15, 196-201.
Greene Burger, S., Kayser-Jones, J., & Prince, J., (2000). Malnutrition and dehydratation in nursing
homes: Key issues in prevention and treatment. Retrieved from
http://www.commonwealthfund.org/publications/publications_show.htm?doc_id=221392
16
Guigoz, Y., Vellas, B., & Garry, P. J. (1994). Mini Nutritional Assessment: a practical assessment tool
for grading he nutritional state of elderly patients. Facts and Research in Gerontology, 2, 15-59.
Jukkola, K., MacLennan, P. (2005). Improving the efficacy of nutritional supplementation in the
hospitalised elderly. Australasian Journal on Ageing, 24(2), 119-124.
Keller, H. H. (1993). Malnutrition in institutionalized elderly: How and why? Journal of the American
Geriatrics Society, 41, 1212-1218.
Kerrigan, E. R., Maxwell, J., & Siegel, C. (1996). Dispensing of a calorically dense oral supplement
with medication pass: a creative approach to oral supplementation. J Am Diet Assoc, 96, A32.
Laporte, M., Villalon, L., & Payette, H. (2001). Simple screening tools for healthcare facilities:
Development and validity assessment. Canadian Journal of Dietetic Practice and Research, 62,
26-34.
Ministère de Santé et de Services sociaux du Québec. (2009). Approche adaptée à la personne âgée en
milieu hospitalier: Cadre de référence. Quebec: La Direction des communications du ministère
de la Santé et des Services sociaux du Québec.
Ministère de Santé et de Services sociaux du Québec. (2013). Livre blanc sur la création d’une
assurance autonomie. Québec : Ministère de Santé et de Services sociaux du Québec.
Nutrition Screening Initiative. (2002). Nutrition statement of principle. Retrieved from
http://www.eatright.org/ada/files/nutrition(1).pdf
Saunders, J., Smith, T., & Stroud, M. (2010). Malnutrition and undernutrition. Undernutrtion and
Clinical Nutrition, 39(1), 45-50.
17
Strange, I., Bartram, M., Liao, Y., Poeschl, K., Kolpatzik, S., Uter, W., ... Volkert, D. (2013). Effects of
a low-volume, nutrient- and energy-dense oral nutritional supplement on nutritional and
functional status: A randomized, controlled trial in nursing home residents. JAMDA, 14, e1-e8.
18
APPENDIX 1
Mini Nutritional Assessment (MNA) tool, short-form
19
APPENDIX 2
Sample of Medication Administration Record (MAR) sheet
20
APPENDIX 3
Nursing mid-way evaluation form

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Report_MEDPASS

  • 1. MCGILL UNIVERSITY Medication Pass Pilot Project Final Report Miriam Tabet Student ID: #260376011 Monday August 4th , 2014
  • 2. 2 ABSTRACT Elderly are at increased risk of malnutrition, due to cognitive impairment, depression, social isolation, polypharmacy, multiple comorbidities, etc. This partly explains why it is estimated that 35% to 85% of long-term care residents are malnourished. Traditional oral nutrition supplementation has been associated increased non-consumption of supplements and therefore suboptimal impact on nutrition management. Therefore, the MedPass pilot project is a new patient-centered approach to prevent malnutrition and the consequences of malnutrition in elderly. The MedPass project takes place at Henri- Bradet long-term care residence, for 12 weeks. Nineteen participants were recruited for maintenances or restoration of adequate nutritional status. The implementation of the project involves distribution of 60 ml of a high-energy, high-protein nutritional supplement (Resource 2.0), 4 times per day, by nurses, with the medication rounds. The MedPass treatment appeared to be beneficial for malnutrition, principally because of the residents full consumption of the energy- and protein-dense supplement. For the majority of participants, the results indicated a positive impact on weight change and BMI, as well as improvement of nutritional status, reflected in the upward shift of the MNA screening score. The project indicated that MedPass would have a potential cost saving element in health care institutions.
  • 3. 3 I. INTRODUCTION Elderly individuals are at increased risk of malnutrition, due to their greater risk of cognitive impairment, depression, social isolation, polypharmacy and multiple comorbidities. The etiology of malnutrition is multifactorial and despite efforts to remain independent, many elderly are admitted to nursing homes, therefore exacerbating their malnutrition risk. It is estimated that the prevalence of malnutrition in the long-term care setting ranges from 35 to 85% (Greene Burger, Kayser-Jones, & Prince, 2000; Keller, 1993; Laporte, Villalon, & Payette, 2001; Nutrition Screening Initiative, 2002). Malnutrition, defined by Saunders, Smith and Stroud (2010) as a "deficiency, excess or imbalance of a wide range of nutrients, resulting in measurable adverse effects on body composition, function and clinical outcome", is known to be one of the most relevant conditions that negatively affects the health of elderly population (Norman, Pichard, Lochs, & Pirlich, 2008). In order to resolve the issue of clinical protein-energy malnutrition, the Medication Pass Nutritional Supplement Program was introduced in 1996 by Kerrigan, Maxwell and Siegel, later termed Med Pass program. This approach involves the distribution of low-volumes (60 mL or 90 mL) of a high-calorie, high-protein nutritional supplement, three to four times a day with medications. This method aims to prevent any disruption of appetite and is well tolerated by volume-sensitive individuals (Dillabough, Mammel, & Yee, 2011). It has been associated with high patient compliance, optimized clinical benefits, reduced product wastage and lower costs (Strange et al., 2013). The purpose of this study is to determine if the implementation of the Med Pass project at Henri-Bradet Residential Center would be an effective method for the treatment of malnutrition in elderly patients. The pilot study has two principal objectives; to evaluate the effects of the Med Pass program on
  • 4. 4 residents' nutritional status through MNA (Malnutrition Nutritional Assessment) score and body weight, and evaluate the supplement waste-associated costs. II. MATERIALS AND METHODS 1. Setting and participants This 3-month pilot study was conducted at a 125-bed long-term care facility in Montreal. Preliminary work for the Med Pass pilot project began in January 2014, while the study duration was from February to May 2014. A total of 19 residents were selected to participate in the study. Baseline selection criteria required all residents to be at least 65 years old, and to be initially receiving traditional oral liquid supplements. To determine eligibility for study participation, residents were screened at baseline, within 1 week interval, using the short-form of the Mini Nutritional Assessment (MNA) tool (Appendix 1), and only those screened as malnourished or at risk of malnutrition were selected. The study eligibility criteria are as follows: residents must be at least 65 years old, not dysphagic, taking oral supplements, have a MNA score of ≤11 and able to provide consent. Study exclusion criteria included residents with adequate nutritional status, dysphagic residents on modified honey or pudding liquid consistency, and cognitively impaired individuals who could not provide consent. To meet regulations of the Ethics Committee of Research of CSSS Cavendish, all the pilot project participants personally gave free and informed verbal consent for study participation. While the 3-month pilot project was taking place, along with data collection of the selected participants, the Med Pass program was running throughout the whole Center, so that all residents assessed by the medical team as benefiting from Med Pass would receive the proper nutritional treatment. This report addresses the methodology and findings only pertaining to the 3-month pilot project and its selected participants.
  • 5. 5 2. Measurements Weights of the residents participating in the pilot project were taken at baseline and monthly by nurses, using the same calibrated balance, from which percent weight change and body mass index (BMI) were calculated. Participants were reweighed if there was a difference of 3 kg or more from the previous month's weight. The MNA tool was conducted at baseline and at project end. Resident adherence to the Med Pass supplement was quantified by a review of medical chart documentation on the medication administration record (MAR) sheet. Nurses documented whether the residents were consuming 1/4, 1/2, 3/4, or all of Med Pass supplements, distributed with medications, four times per day (Appendix 2). The pharmacist reviewed each participating resident's medication profile for potential food-drug interaction, and none were found. Since Med Pass supplements replaced traditional oral supplements, there was no need to assess the participants' consumption of the latter. Finally, mid-way staff perception was assessed at week 6, using a non-validated evaluation survey that determined continuation or cessation of the Med Pass pilot project. 3. Procedure and implementation The implementation of the pilot project started in January 2014. Once the Med Pass project was presented to the public and to the multidisciplinary team of the center, the protocol was officially launched on February 2014, using an energy-dense and protein-dense nutritional supplement called Resource 2.0. This product was already available at the facility, in the 946 mL bottle format, providing 2 kcal/mL and 0.08 g protein/mL, and is suitable for diabetic patients, as well as those with regular and nectar liquid consistency. The nurses provided 60 ml of Resource 2.0 with medications, four times per day thus providing 480 kcal/day and 20 g protein/day and 25% of the recommended intake of vitamins and minerals in addition to their normal food intake. Resource 2.0 (946 mL bottle format) costs 1.37$.
  • 6. 6 During the pilot study, other supplements were discontinued and replaced with Resource 2.0, while actual high-energy, high-protein foods continued as is. III. RESULTS 1. Participants characteristics From the initial 19 residents eligible for project participation, only 15 completed the study since 1 was discharged and 3 were discontinued for project abandon; from which 2 changed their mind about their consent regarding study participation (each after 1 week and 4 weeks), while 1 other refused to continue gaining more weight after 8 weeks of study participation. The results presented are for the 15 residents who completed the 3-month pilot study period. Statistical analysis was calculated using SAS 9.4 software and paired t-test were performed in order to assess the significance in change of weight. The sample size was composed of 5 men and 10 women, with a mean age of 86.7 years old (SD 7.0; age range 67 to 96). The results from the initial MNA screening tool revealed that 7 out of 15 residents were at risk for malnutrition and 8 were already malnourished, with a mean MNA score of 7.7 points (SD 2.4). Using the BMI classification suggested by the "Guide Pratique d'Évaluation de l'État Nutritionnel" (Boivin, Gélinas, Lacroix, Maltais, Lavandier, & Morin, 1993), where normal BMI range for 65-80 years old is 20-27 kg/m2 , and normal BMI for 80+ years old is 20-29 kg/m2 , it was found that 10 out of 15 residents were underweight and 5 were of normal weight, with an overall mean BMI of 20.3 kg/m2 (SD 3.8), equivalent to the lower range of normal BMI classification. 2. Weight change During the pilot study period, 11 out of 15 residents (73%) made positive weight gains while only 4 (27%) lost weight, for an average weight change of +1.2 kg, calculated as +2.2% (p < 0.05) of initial weight. As per the Omnibus Budget Reconciliation Act of 1987, significant weight gain is 5% of body
  • 7. 7 weight in 30 days, 7.5% in 60 days, or 10% in 180 days. From the residents who experienced weight gain, the average weight gain was significant, being 2.2 kg (+4.1%; p = 0.05) in 3 months. In May, two participants (E and H) refused to be weighted. The total weight change and calculated percent of weight change are represented for a shorter period of time, 2 months, based on the last weight available in April. As depicted by Graph 1 below, weight gain of the participants is more prevalent than weight loss, since 11 of 15 participants experienced weight gain, and only 4 lost weight. Graph 1 Percentage of weight change (%) per participant in 3-month period. 4. MNA score The results from the initial MNA screening tool revealed that 7 out of 15 residents at risk for malnutrition and 8 were already malnourished, with a mean MNA score of 7.7 points. Final MNA score reassessment after the 3-month period revealed a significantly higher mean score of 9.0 points (p < 0.05). In parallel with the primary study objectives concerning change in body weight, this study
  • 8. 8 examined changes for the two weight-related questions scores that could possibly be influenced by Med Pass supplementation. During the duration of the pilot study period, Question B ("weight loss during the last 3 months") had a mean score increase from baseline 2.4 (SD 1.0) to 2.6 (SD 0.8), still classifying the findings between the same answer categories 2-weight loss between 1 and 3 kg and 3-no weight loss (p > 0.05) . While Question F1 ("BMI kg/m2 ") also had a mean score increase from 1.3 (SD 1.3) to 1.5 (SD 1.3), still classifying the final score between 1-BMI 19 to less than 21 and 2-BMI 21 to less than 23 answers (p > 0.05). The change in each participant's MNA score results (total score, question B score and question F1 score) is summarized in Graph 2 below. Graph 2 Participants' baseline and final total MNA score, Question B MNA score and Question F1 MNA score (points) 5. Supplement costs Since the amount of calories and protein vary per nutritional product, it is necessary to compare the price per 1000 kcal and per 1g protein, for accurate between-product cost comparison. See Table 1 below for a visual comparison between 235-237 mL format supplements of Resource 2.0 (used for Med Pass
  • 9. 9 program), Ensure regular and Ensure Plus. Calculations demonstrate that the cost of Resource 2.0 per mL is slightly more than Ensure Plus but it is also slightly less than the other frequently used product, Ensure regular. As part of the Med Pass project, the dietary department is only providing the large (946 mL) Resource 2.0 format to the floors for an enhanced ease of use for the nursing staff. As demonstrated in Table 6 below, the purchase cost per 1000 kcal and per 1 g protein of this large 946 mL format is significantly more expensive than any other smaller supplement format. More specifically, compared to the smaller format (237 mL) of the same product, the large Resource 2.0 format is 35% more expensive per 1000 kcal and 88% more expensive per 1g protein. Table 1 Price comparison per 1000 kcal and per 1g protein, for nutritional supplements Resource 2.0, Ensure regular and Ensure Plus Table 2 and Graph 3 below summarize the monetary impact of the Med Pass program on total supplements cost, including Med Pass and non-Med Pass supplement use. There was a 30% decrease in total supplement cost for the 3-month study duration, despite the gradual increase then stabilisation of Product Price per case Price per format Cal / format Protein/ format Price per 1000 kcal Price per 1g of protein Ensure regular (case of 24 bottles of 235 ml) 11,62$ 0,484$ 250 Cal 9,4 g 1,94$ 0.050$ Ensure Plus (case of 24 bottles of 235 ml) 13,51$ 0,563$ 355 Cal 13,5 g 1,58$ 0.041$ Resource 2.0 (case of 27 tetras of 237 ml) 24,26$ 0,90$ 480 Cal 20 g 1,88$ 0.045$ Resource 2.0 (case of 12 tetras of 946 ml) 65,70$ 5,46$ 1915 Cal 80 g 2.9$ 0.373$
  • 10. 10 Resource 2.0 supplement use. This shifting in supplement costs was due to the significant 44% decrease in non-Med Pass supplement use (Boost, Ensure, Boost diabetic, Glucerna, Novasource Renal, etc.) that were gradually substituted by Resource 2.0 supplements, throughout the Center. Table 2 Monthly cost (February to May 2014) of total supplements, non-Med Pass supplements and Resource 2.0, as well as total percentage change Graph 3 Baseline and final cost (February and May 2014) of total supplements, non-Med Pass supplements and Resource 2.0 6. Participants adherence Compliance to Med Pass was high. From the 15 residents included in the pilot project, all were 100% compliant.
  • 11. 11 7. Nursing staff perception The non-validated mid-way evaluation form was completed by a total of 9 nursing employees at the Henri-Bradet centre. Results demonstrate that 88.9% of respondents affirmed that they strongly agree/agree that passing out Resource 2.0 to residents (Question 1) and that documenting resident’s intake on the MAR sheet (Question 2) is simple. Respectively, 87.5% and 71.4% of respondents strongly agree/agree that compliance for intake of Resource 2.0 is good (Question 3) and that there is less non-Med Pass supplement use (Question 4). Finally, 85.7% of respondents strongly agree/agree that residents taking Resource 2.0 appear to have an improved health status (Question 5), and 88.9% said that the med Pass Program is beneficial and should be continued (Question 6). IV. DISCUSSION The 3-month Med Pass program had a positive impact on the weight of the subjects, but not as clinically significant as expected, based on the promising findings of previous literature assessing the impact of Med Pass on anthropometrical nutritional markers (Kerrigan, Maxwell, & Siegel, 1996; Lewis, & Moyle, 1998; Dillabough, Mammel, & Yee, 2011; Welch, Porter, & Endres, 2003; Doll-Shankaruk, Yau, & Oelke, 2008; Remsburg, Sobel, Cohen, Koch, & Radu, 2001; Jukkola, & MacLennan, 2005; Strange et al., 2013). Although weight gains were statistically significant (p < 0.05) and occurred for most of the subjects, they were smaller than expected. For the participants' weight gain to be significant and within the guidelines of the Budget Reconciliation Act of 1987, this would have required the residents to meet their nutritional needs consuming the meals provided, with the additional Med Pass supplemental calories for intended weight gain. Resource 2.0 fully consumed (60 ml four times/day), theoretically translates to a gain of 0.44 kg (0.96 lbs) per week. One could speculate that the participants who consumed the totality of the supplements ate less than their nutritional needs through food, on most study days. The residents who lost weight were known to be eating very little food for various reasons.
  • 12. 12 Among residents taking Resource 2.0, greater weight loss may have occurred due to poor nutritional intake had they not had the supplement. This knowledge-based assumption would need to be validated by assessing the amount of food and calories daily ingested by the participants. The Med Pass program had a significant (p < 0.05) positive impact on the MNA short-form result scores, since the initial mean MNA score upgraded from 7.7 points (SD 2.4), to the final MNA score of 9.0 points (SD 2.3). The increase in mean MNA scores revealed that after the 3-month period, the pilot project participants went from the "malnourished" classification (higher range) to the "at risk of malnutrition" (lower range), indicating a clinically significant improvement in malnutrition status despite the short period of study time. The score change of two MNA short-form questions pertaining to weight change, respectively Question B ("weight loss during the last 3 months") and Question F1 ("BMI kg/m2 "), an increase in mean score was also noted from 2.4 (SD 1.0) to 2.6 (SD 0.8), as well as from 1.3 (SD 1.3) to 1.5 (SD 1.3). Even though an increase in mean score of those two specific questions was observed, this was not clinically significant within the 3-month period of time, since it still classifies the findings between the same answer categories, respectively 2-weight loss between 1 and 3 kg and 3-no weight loss and 1-BMI 19 to less than 21 and 2-BMI 21 to less than 23. Since the MNA short-form assessment comprises data on anthropometry, dietary assessment and general assessment it is believed that the results observed would have been more significant in a longer than 3-month study period of time. Compliance on the Med Pass system was high. The cost of Resource 2.0 per ml is slightly more than some of the other supplements, but it is also slightly less than one of the most frequently used products (Ensure regular). The traditional supplement are known to go to waste compare to the Med Pass system. This explains why the monthly cost of total supplements went down to attain a 30% decrease within the
  • 13. 13 3-month pilot project. In Table 7, the Med Pass supplement (Resource 2.0) cost has been fluctuating, depicting the adjustments in quantity ordered and purchased throughout the establishment. The hypothesis of the residents' adherence, is due to the supplement being distributed in small quantities (60ml) between meals. Also, Resource 2.0 was perceived by the residents as a medical treatment which could explain the totality of amount ingested. It’s possible that residents are more compliant to a perceived medical therapy versus a dietary supplement provided in its container and served with meals. As demonstrated by the mid-way evaluation, the nurses seemed pleased with the Med Pass program. Most importantly, 88.9% of respondents said that the program is beneficial and should be continued (Question 6 of the mid-way evaluation form). The nurses did not perceive the program as an increase of workload, but welcomed it as a new tool for the treatment and prevention of malnutrition, even if it required extra nursing time. The positive outcome of the mid-way questionnaire decided that the project should continue until the 12th week. The baseline MNA nutritional screening permitted validation of the previously documented severity of the issue of malnutrition in elderly living in long-term care facilities (Greene Burger, Kayser-Jones, & Prince, 2000; Keller, 1993; Laporte, Villalon, & Payette, 2001; Nutrition Screening Initiative, 2002), which stresses the importance of nutritional management. However, the studied sample was not representative of the Henri-Bradet Residential Center's total population. First, due to the small sample size (n= 15) and second, because inclusion criteria comprised non-severely cognitively impaired residents, and residents on regular and nectar liquid consistency, while literature demonstrated that elderly with cognitive impairment or with dysphagia are at increased risk of malnutrition (Ministère de Santé et de Services sociaux du Québec, 2011).
  • 14. 14 V. CONCLUSION The Med Pass treatment appeared to be beneficial in treating malnutrition. For the majority of participants, the results indicated a positive impact on weight change. The pilot project indicated that Med Pass would have a potential cost saving element in health care institutions. This pilot project is relevant to clinical nutrition as it offers an alternative to low-compliance and suboptimal nutritional impact associated to traditional nutritional supplementation. It is believed that the Med Pass program, offered in conjunction with a high quality menu, would be a patient-centered and cost-effective approach for the management and treatment of malnutrition.
  • 15. 15 REFERENCES Chevalier, S., Desjardins, I., & Mainville, D. (2008). Dépistage de la dénutrition et impact d'une intervention nutritionnelle chez les personnes âgées en soins de longue durées. Nutrition: science en évolution, 6(1), 17-20. Chumlea, W. C., Roche, A. F., & Steinbaugh, M.L. (1985). Estimating stature from knee height for persons 60 to 90 years of age. Journal of the American Geriatrics Society, 33(2), 116-20. Comité des diététistes en évaluation nutritionnelle gériatrique (1993). Guide Pratique D'Évaluation de l'État Nutritionnel. Canada, Québec: Boivin, D., Gélinas, M. D., Lacroi, G., Maltais, M., Lavandier, L. M., & Morin, A. Constans, T., Bacq, Y., Brechot, J., Guilmot, J., Choutet, P., & Lamide, F. (1992). Protein energy malnutrition in elderly medical patients. Journal of the American Geriatrics Society, 40, 263- 268. Covinsky, K., Martin, G., Beyth, R., Justice, A., Seghal, A., Landefeld, C. (1999). The relationship between clinical assessments of nutritional status and adverse outcomes in older hospitalized medical patients. Journal of the American Geriatrics Society, 47, 532-538. Dillabough, A., Mammel, J., & Yee, J. (2011). Improving nutritional intake in post-operative hip fracture patients: A quality improvement project. Journal of Orthopedic and Trauma Nursing, 15, 196-201. Greene Burger, S., Kayser-Jones, J., & Prince, J., (2000). Malnutrition and dehydratation in nursing homes: Key issues in prevention and treatment. Retrieved from http://www.commonwealthfund.org/publications/publications_show.htm?doc_id=221392
  • 16. 16 Guigoz, Y., Vellas, B., & Garry, P. J. (1994). Mini Nutritional Assessment: a practical assessment tool for grading he nutritional state of elderly patients. Facts and Research in Gerontology, 2, 15-59. Jukkola, K., MacLennan, P. (2005). Improving the efficacy of nutritional supplementation in the hospitalised elderly. Australasian Journal on Ageing, 24(2), 119-124. Keller, H. H. (1993). Malnutrition in institutionalized elderly: How and why? Journal of the American Geriatrics Society, 41, 1212-1218. Kerrigan, E. R., Maxwell, J., & Siegel, C. (1996). Dispensing of a calorically dense oral supplement with medication pass: a creative approach to oral supplementation. J Am Diet Assoc, 96, A32. Laporte, M., Villalon, L., & Payette, H. (2001). Simple screening tools for healthcare facilities: Development and validity assessment. Canadian Journal of Dietetic Practice and Research, 62, 26-34. Ministère de Santé et de Services sociaux du Québec. (2009). Approche adaptée à la personne âgée en milieu hospitalier: Cadre de référence. Quebec: La Direction des communications du ministère de la Santé et des Services sociaux du Québec. Ministère de Santé et de Services sociaux du Québec. (2013). Livre blanc sur la création d’une assurance autonomie. Québec : Ministère de Santé et de Services sociaux du Québec. Nutrition Screening Initiative. (2002). Nutrition statement of principle. Retrieved from http://www.eatright.org/ada/files/nutrition(1).pdf Saunders, J., Smith, T., & Stroud, M. (2010). Malnutrition and undernutrition. Undernutrtion and Clinical Nutrition, 39(1), 45-50.
  • 17. 17 Strange, I., Bartram, M., Liao, Y., Poeschl, K., Kolpatzik, S., Uter, W., ... Volkert, D. (2013). Effects of a low-volume, nutrient- and energy-dense oral nutritional supplement on nutritional and functional status: A randomized, controlled trial in nursing home residents. JAMDA, 14, e1-e8.
  • 18. 18 APPENDIX 1 Mini Nutritional Assessment (MNA) tool, short-form
  • 19. 19 APPENDIX 2 Sample of Medication Administration Record (MAR) sheet
  • 20. 20 APPENDIX 3 Nursing mid-way evaluation form