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Randomized Control Trials Community optimized management for better eating after hospital sTay among geriatric patients of poor socio-economic status - The COMEAT study Miriam Theilla a, b, Pierre Singer a, *, Boaz Tadmor c, Itai Bendavid a, Moran Hellerman a, Ilya Kagan a a Department of General Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Sackler School of Medicine, Tel Aviv University, Petah Tikva, Israel b Tel Aviv-Yaffo Academic College School for Nursing Sciences, Israel c Administration Ofﬁce, Rabin Medical Center, Beilinson Hospital, Sackler School of Medicine, Tel Aviv University, Petah Tikva, Israel a r t i c l e i n f o Article history: Received 3 April 2022 Accepted 13 June 2022 Keywords: Malnutrition Socio-economic Continuity of care Oral nutrition s u m m a r y Introduction: In patients suffering from disease-related and socioeconomic malnutrition and being dis- charged from hospital, continuity of care is challenging. Lack of adequate nutrition may lead to increase in morbidity and mortality. The aim of this study was to overcome the handicap of limited nutrition access in this category of patients and to study its consequences on clinical outcome. Methods: Hospitalized patients screened to be at risk of malnutrition were approached and if diagnosed as suffering from malnutrition and from limited ﬁnancial resources, they were randomized to receive a delivered daily dinner tray for 6 months and an assistance during the meal by a philanthropic associa- tion, or to regular food. At entry to the study, patients were assessed by indirect calorimetry, bio- impedance, Hospital Anxiety and Depression Scale (HADS), Functional independence measure (FIM) and SF 36 quality of life questionnaire. The latest questionnaires were reproduced after 3 and 6 months. Survival was followed at 6 months. The student t-test, the paired t-test, ANOVA were used. 180 days survival curves were expressed using the Kaplan-Meier method. Results: 631 patients were screened and 60 patients were randomized. There was no difference between groups. Survival at 6 months was improved signiﬁcantly in the intervention group (87%) compared to the control group (65%, p<005). HADS did signiﬁcantly improve at 3 months and other parameters (FIM, SF 36) were not changed signiﬁcantly. Conclusions: In hospitalized patients at nutritional risk, lunch home delivery, supported by a physical company after hospital discharge was associated with signiﬁcantly lower mortality rates and improved depression and anxiety scores in elderly patients suffering from socioeconomic related malnutrition © 2022 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. 1. Introduction Malnutrition affects health outcomes and survival mainly among the geriatric population [1,2]. A study surveying 16,290 hospitalized patients indicated that on the day of data collection (NutritionDay) and during the week prior to inclusion more than half of the patients did not eat more than half the meal provided. Insufﬁcient food intake is an independent risk factor for mortality, regardless of the patient's diagnosis [3]. Various physical, mental and social conditions contribute to the development of malnutrition in older adults [4,5]. A model called DoMAP (Determinants of Malnutrition in Aged Persons ((4) has been deﬁned out of 122 potential causes for malnutrition, including 3 main factors: low intake, increased requirements, and impaired nutrient bioavailability, but other parameters were also included such as demographics, ﬁnancial, food, appetite, longevity, psycho- logical function, physical function, comorbidities and therapies. In addition, direct and indirect causes that contribute to malnutrition, such as low income, poverty, lack of ability to prepare meals and * Corresponding author. General Intensive Care department and Institute for Nutrition Research Rabin Medical Center, Beilinson Hospital Petah, Tikva, 49100, Israel. Fax: þ97239232333 E-mail address: [email protected] (P. Singer). Contents lists available at ScienceDirect Clinical Nutrition journal homepage: http://www.elsevier.com/locate/clnu https://doi.org/10.1016/j.clnu.2022.06.023 0261-5614/© 2022 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. Clinical Nutrition 41 (2022) 1746e1751 Downloaded for Anonymous User (n/a) at Shamir Medical Center Assaf Harofeh from ClinicalKey.com by Elsevier on April 07, 2025. For personal use only. No other uses without permission. Copyright ©2025. Elsevier Inc. All rights reserved. solitude, i.e., the absence of company with the feeling of loneliness, play important roles as well. Other studies conﬁrm that in adult malnutrition patients that are discharged from the hospital, social, economic and environmental factors increase the incidence and severity of depression and anxiety and are related to impaired quality of life [5e9]. Schorr et al. [6] revealed that appropriate food supply to the geriatric population may overcome two main hindrances: lack of money to buy food and the depression and anxiety impairing food preparation. In the hospital, between 30% and 85% of hospitalized patients suffer from malnutrition according to different surveys [10]. Eating adequately while being hospitalized is often a matter of necessity rather than pleasure as means to reduce hospital stays, malaise and even mortality [11]. During the hospitalization course, patients' nutritional conditions deteriorate, a phenomenon that was given the name “hospital malnutrition” [12]. Hospital malnu- trition usually persists in the patients' home environment following hospitalization [13]. Hospitalized patients consume lower amounts of food due to various causes, not the least the underlying disease and screening tools have been developed to diagnose patients at risk of malnutrition [14]. A vicious cycle that begins with a decrease in food consumption prior to hospitaliza- tion, worsens during the hospital stay, and continues after discharge from the hospital back to the patient's natural environ- ment, for reasons such as anorexia, depression, cognitive impair- ment, lack of access to food and increased risk of post- hospitalization complications [15e17]. The aim of this research was to evaluate the effects of provision of adequate nutrition and company support in patients' homes after hospital discharge in a population of patients with malnutrition related to the aforementioned socio-economic factors. The end- points were 6 months survival, patients’ quality of life, including the improved level of anxiety and depression, functional inde- pendence measure (FIM) and the rate of resources utilization (outpatient clinic visits, hospital readmissions). 2. Material and methods 2.1. Patients and setting All patients hospitalized to our institution, a tertiary university- afﬁliated centre, were screened systematically. Hospitalized pa- tients were selected using a computerized system that selected patients according to their nutritional status as deﬁned by the MUST (malnutrition universal screening tool) screening tool to identify patients at risk (score of 2 or higher) and if their address was in Petah Tikva, the city supporting the initiative in which our hospital is located. The information was addressed to the investi- gator and patients at risk of malnutrition were approached. After explanation of the course of the study, patients were included in the study after informed consent was obtained. Patients were asked to provide information to the Petah Tikva municipality welfare department detailing their resources, including incomes. Only those with poor incomes, including retirement allocation (less than the equivalent of 1500 Euros per month), were included in the study after conﬁrmation with the social services of Petah Tikva. Patients were randomized into two groups: the control group took their regular nutrition at home for 6 months and the intervention group received a daily dinner tray sponsored by the municipality. “Igud Hazala”, a philanthropic organization, encouraged the inter- vention group patients at lunch for 6 months by sending a volun- teer to patients' homes during meal times to provide company. The study was approved by the Rabin medical centre institutional re- view board (0390-16 RMC). Patients eligible for inclusion were adults (age above 18 and below 90 years) that were considered to be cognitively sound, city residents, at risk of malnutrition (MUST above 2) and with an in- come lower than 1,500 Euros. Exclusion criteria included advanced cancer, dementia and signiﬁcant psychiatric illnesses. Patients receiving nourishment via a feeding tube or PEG (percutaneous endoscopic gastrostomy) were excluded as well. Food supplementation: the daily trays included balanced com- binations of carbohydrates, lipids and protein in seven available options (Supplement 1). Chosen lunch trays were delivered weekly to patient homes. 2.2. Study measures Demographics data were drawn from the patient's data docu- mented in the electronic medical record (Chameleon, Electronic Medical Record (EMR) software system, Israel), and included hos- pitalization diagnosis, sex, age, body weight, height, BMI (body mass index) and MUST score. All patient data were anonymized for analysis. Upon inclusion, an evaluation of the body composition was conducted using the bioimpedance technique (Bioelectrical Imped- ance Analysis) (BIA 4000 Bodystat 4000, UK). Measurement of body mass, fat mass, fat free mass (total body mass minus the fat), impedance and resistance were obtained, and the phase angle ac- cording to the Kyle and Horie equations [18] was calculated. Resting energy expenditure was measured using indirect calorimetry (Fit- mate, COSMED, Rome, Italy) [19]. The Hospital Anxiety and Depression Scale (HADS) questionnaire was ﬁlled on enrolment and was repeated by phone after 3 and 6 months. Quality of life was assessed using the 36 SF questionnaire [20], using a in previously validated Hebrew version [21]. This questionnaire was devised in order to supply a brief and all-inclusive tool that holds to required psychometric standards, for purposes of comparison between generic health concepts, and which provides a multi-dimensional representation of health concepts, including the individual level and personal evaluation of the health situation. Functional independence measure (FIM) questionnaire [22] was used for the assessment of functioning and the level of indepen- dence in light of patient disabilities. The questionnaire was completed by a professional, familiar with the subject's functional ability, with emphasis on what the subject actually did or didn't do in the majority of time. The questionnaire is composed of 18 motoric, cognitive and communicative tasks. Each task is granted 1- 7 points, according to the level of independence. A ranking between 1 and 5 indicates a need for assistance and supervision from another person. A ranking of 6 indicates conditional independence and a ranking of 7 indicates full independence. The possible cu- mulative score ranges between 18 (minimal functioning) and 126 (maximal functioning). FIM was assessed on enrollment and after 3 and 6 months. The volunteers visiting the patients reported any side effect or signiﬁcant event that could affect the patient. Use of resources such as medications, physician visits and hospital readmissions were reported using the computerized database of Clalit health services, the leading provider of health care in Israel. Survival was evaluated using a computerized system (American Trans-Data, Corp (ATD) 180 days after meal provision was initiated. 2.3. Statistical analysis In order to calculate the required sample size, a power analysis was performed using G*Power 3.1 [23]. The sample required to achieve a power of 80%, and a of .05 was 50 patients in each group, a M. Theilla, P. Singer, B. Tadmor et al. Clinical Nutrition 41 (2022) 1746e1751 1747 Downloaded for Anonymous User (n/a) at Shamir Medical Center Assaf Harofeh from ClinicalKey.com by Elsevier on April 07, 2025. For personal use only. No other uses without permission. Copyright ©2025. Elsevier Inc. All rights reserved. total of 100 participants. Statistics were calculated using SPSS version 25 (SPSS, Inc., an IBM Company, Chicago, IL). Demographic variables were expressed as means and standard deviations (SD). The student t-test was used to calculate the means of two inde- pendent variables. The paired t-test was used to compare mean differences when paired variables were obtained in the two groups. ANOVA was used to compare the repeated measurements of HADS, FIM and the SF 36 scores between the intervention and control groups on admission and after 3 and 6 months. 180 days survival curves were expressed using the KaplaneMeier method and compared with using the log-rank test and multivariable Cox regression were used. The schemes of points were to observe the probabilities of total survival for each patient in 2-study groups. We used a p-value of 0.05 to determine statistical signiﬁcance. 3. Results During the period of the study, 631 patients were screened (Fig. 1). Only 60 elderly discharged patients suffering from nutri- tional risk and socio-economic frailty were ﬁnally included (29 in the control and 31 in the study group). There was no signiﬁcant statistical difference between the groups in terms of age, gender, BMI, MUST score, body composition-FFMI (fat free mass index), energy requirements per REE measurements or ﬁnancial income. Table 1 summarizes the baseline characteristics. Patients included had low REE and in FFMI values, establishing the diagnosis of malnutrition according to the recent GLIM deﬁnition [24]. Six months survival was signiﬁcantly higher in the intervention group (27/31e87%) compared to the control group (19/29e65%, p < 0.05) (Fig. 2). HADS scores were signiﬁcantly higher in the intervention group compared to the control group (P < 0.05) after 3 months (12.77 ± 3.6; 8.45 ± 3.0, respectively, p < 0.05). The HADS anxiety score was 12.36 ± 3.9 in the intervention vs. 7.92 ± 5.5 in the control group (p < 0.05) and the HADS depression score was 13.18 ± 3.0 vs. 9.0 ± 3.6, respectively (p < 0.05). These data are shown in Fig. 3. The analysis of the “Quality of Life” questionnaire (SF 36) yielded no signiﬁcant difference, neither between the designated time periods nor between the two study groups. There was a trend towards elevation in the FIM questionnaire during the six months of the study in the study group, but this improvement was not statistically signiﬁcant. Moreover, no signiﬁcant difference was observed in the number of hospitalizations, emergency department visits or medications changes between the study groups (Table 2). 4. Discussion The study shows that the supplementation of a daily meal tray combined with companionship during said meal was associated with decreased mortality rates as well as lower depression and anxiety scores in low-income elderly patients at risk for malnutri- tion after hospitalization. There was no signiﬁcant difference in the overall quality of life, the number of readmissions or the number of medications. Fig. 1. Flow chart of the study recruitment process. M. Theilla, P. Singer, B. Tadmor et al. Clinical Nutrition 41 (2022) 1746e1751 1748 Downloaded for Anonymous User (n/a) at Shamir Medical Center Assaf Harofeh from ClinicalKey.com by Elsevier on April 07, 2025. For personal use only. No other uses without permission. Copyright ©2025. Elsevier Inc. All rights reserved. Malnutrition is a widespread phenomenon among elderly pa- tients and its relation to poor outcomes has been well established [25], especially after hospitalization [13]. All the patients in the current study were at risk for malnutrition and it was expected that their nutritional status might deteriorate during and after their hospitalization course. The mean age of the study population was 77 years and the mean monthly income 1,420 Euros or 5,100 NIS (new Israeli Shekels), which is considered a very household income, allowing for the most basic standards of living, practically falling under the deﬁnition of poverty. Previous works have determined a signiﬁcant correlation between low income and malnutrition [26,27] and poor socio-economic states have been included in the ESPEN list of conditions predisposing to malnutrition [24]. As revealed in a previous study, the incidence of malnutrition in the elderly population is possibly even higher than the incidence reported for the general population, largely due to greater eco- nomic adversity [28]. High economic resources afforded protection from malnutrition [29] while undernutrition was related to social factors [8]. Negative social factors including loneliness, lower socio- economic levels, and solitary marital states, i.e. divorced, single or widowed, were all found to contribute to the development of malnutrition since they were associated with decreased food intake and depression [16]. The lack of cooking skills or habits of un- healthy cooking may further impair the nutritional condition [17]. As feelings of loneliness were reported as higher, the prevalence of depression increased and the caloric intake decreased. It has also been shown that elderly people who experienced loss of social interactions derived less enjoyment from eating [30,31]. Our results show that ensuring a daily meal tray taken with the company of a volunteer can reduce the anxiety and depression Table 1 Comparison of baseline demographic and nutritional characteristics between the two study groups on admission. SD: standard deviation; BMI: body mass index; FFMI: fat-free mass index; MUST: malnutrition universal screening tool; REE: resting energy expenditure; NIS: new Israeli Shekel. Variables Control group N ¼ 29 Mean (SD) Study group N ¼ 31 Mean (SD) P-value Age (years) 77 ± 7 77 ± 10 NS Sex (male/female) 18/11 15/16 NS BMI (kg/m2) 23.1 ± 6.4 24.6 ± 4.3 NS MUST 2.42 ± 0.7 2.5 ± 0.7 NS REE (kcal/d) 1217 ± 456 1418 ± 338 NS FFMI (kg/m2) 15.8 ± 4.8 15.5 ± 3.5 NS Phase Angle () 3.9 ± .9 3.8 ± .7 NS Income (NIS/month) 5015 ± 1712 5112 ± 1686 NS Euros/month 1 Euro ¼ 3.4 NIS at date of conversion 6/2020 1,475 ± 971 1,503 ± 496 NS Fig. 2. KaplaneMeier survival curves for the intervention and control and groups. *P 0.05 M. Theilla, P. Singer, B. Tadmor et al. Clinical Nutrition 41 (2022) 1746e1751 1749 Downloaded for Anonymous User (n/a) at Shamir Medical Center Assaf Harofeh from ClinicalKey.com by Elsevier on April 07, 2025. For personal use only. No other uses without permission. Copyright ©2025. Elsevier Inc. All rights reserved. associated with undernutrition. Loneliness is a factor of depression, and using an NGO (Non- Governmental Organization) to provide company to elderly lonely patients may improve their feelings and decrease their level of anxiety and depression as described in our study. There is almost no study available that actively compares the efﬁcacy of meals on malnutrition in elderly patients following hospitalization. In one study on Canadian seniors that used community-based services comprising a meal plan and a social component like supportive housing or family support with meals, there were lower rates of malnutrition risk in those receiving nutritional support [32]. Another ﬁnding of this study was the as- sociation between providing food actively and reducing mortality after hospitalization, a ﬁnding similar to ours. A previous study demonstrated that undernutrition could increase the risk for mortality [33] and might also inﬂuence various complications, including higher hospitalization rates and poorer quality of life [33]. In contrast, our ﬁnding did not ﬁnd a signiﬁcant effect on the quality of life, readmission events or the number of medication despite the decreased anxiety and depression levels in the inter- vention group that could have been attributed to the accompanying volunteers during the dinner. In a recently published study, Sanchez-Torralvo and colleagues [34] found a signiﬁcant associa- tion between malnutrition and the levels of anxiety and depression in older hospitalized cancer patients [34]. Patients suffering from depression tend to eat smaller quantities of low-quality food and therefore lose weight and muscle, in turn contributing to the development of malnutrition [35]. Malnutrition was signiﬁcantly more prevalent among older depressed patients compared to the non-depressed population [36]. Moreover, poor socio-economic states also increased the rates of depression and anxiety in the geriatric population [37]. Depression, anxiety and ﬁnancial hard- ship are all independent risk factors for malnutrition as well as increased morbidity and mortality rates [38,39]. Our study is the ﬁrst study to our knowledge that attempted to break the vicious circle of the malnourishment in elderly patient of low socio-economical states discharged from the hospital and face difﬁculties recovering alone from the disease and the associated malnutrition. Our protocol targeted several points in combination: screening and diagnosis during hospitalization, post-discharge plan of providing daily ensured meals delivered home, the offering of company to encourage the patient to increase his intake and the nutritional and mental follow-up evaluations, and to our knowl- edge was unique. This combined approach achieved an improve- ment in the survival rates, the degree of malnutrition and the related anxiety and depression. Our study had several limitations. Recruitment was limited owing to several hindrances, explaining the small number of patients included in the study. Patients were reluctant to disclose their income Fig. 3. Hospital Anxiety and Depression Scale (HADS) according to the time interval in the study groups. *: P > 0.05 between baseline and 3 months HADS Anxiety and Depression. Table 2 Comparison of other parameters between the two study groups at day 0 and after 3 and 6 months. FIM: Functional Independence Measure. ADL: activities of daily living. SF-36: short form questionnaire 36. *P < 0.05 Parameter Study Group (N ¼ 31) Control Group (N ¼ 29) Day 0 After 3 month After 6 month Day 0 After 3 month After 6 month P Mean ± SD Mean ± SD Functional independence measure (FIM) ADL 38 ± 16 40 ± 19 45 ± 18 39 ± 20 42 ± 21 43 ± 20 NS Moto 29 ± 14 30 ± 14 32 ± 12 27 ± 15 32 ± 17 32 ± 15 NS Social 31 ± 8 30 ± 8 30 ± 7 29 ± 7 29 ± 7 30 ± 6 NS Total FIMFﬁg 32 ± 11 33 ± 14 36 ± 13 31 ± 12 34 ± 13 35 ± 13 NS Quality of Life SF-36 2.6 ± .28 2.1 ± .32 2.4 ± .56 2.4 ± .27 2.1 ± .22 2.2 ± .49 NS Medication (number) 7.1 ± 4.3 6.6 ± 3.8 7.4 ± 3.8 7.3 ± 4.3 NS Readmission (nunber) 2.3 ± 2.2 2.3 ± 2.4 NS Surgery (number) .51 ± .9 .65 ± 1.7 NS M. Theilla, P. Singer, B. Tadmor et al. Clinical Nutrition 41 (2022) 1746e1751 1750 Downloaded for Anonymous User (n/a) at Shamir Medical Center Assaf Harofeh from ClinicalKey.com by Elsevier on April 07, 2025. For personal use only. No other uses without permission. Copyright ©2025. Elsevier Inc. All rights reserved. out of shame or for protection of their privacy. They were also reluc- tant to receive meal delivery on a regular basis as they feared neigh- bors' judgment. Some rejected the offered meals because of incompatibility of taste related to ethnic origin as well as meal stan- dardization for budgetary purposes. Efﬁcient recruitment was also hindered by the fact that many eligible patients were not discharged directly to home but rather to rehabilitation or nursing home, pre- cluding their inclusion in the study. It should also be noted that the study was interrupted due to changes in the city's mayorship; how- ever, it was relaunched after approval by the new municipality. 5. Conclusions In hospitalized patients at nutritional risk, lunch home delivery, supported by a physical company after hospital discharge was associated with signiﬁcantly lower mortality rates and improved depression and anxiety scores in elderly patients suffering from socio-economic related malnutrition. These ﬁndings should encourage larger prospective studies. Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.clnu.2022.06.023. References [1] Buys DR, Roth DL, Ritchie CS, Sawyer P, Allman RM, Funkhouser EM, et al. Nutritional risk and body mass index predict hospitalization, nursing home admissions, and mortality in community-dwelling older adults: results from the UAB Study of Aging with 8.5 years of follow-up. J Gerontol A Biol Sci Med Sci 2014;69:1146e53. [2] Yang Y, Brown CJ, Burgio KL, Kilgore ML, Ritchie CS, Roth DL, et al. 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