Elsevier

Clinical Nutrition

Volume 23, Issue 2, April 2004, Pages 195-204
Clinical Nutrition

ORIGINAL ARTICLE
A prospective randomised controlled trial of nutritional supplementation in malnourished elderly in the community: clinical and health economic outcomes

https://doi.org/10.1016/S0261-5614(03)00107-9Get rights and content

Abstract

Background & aims: Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs.

Methods: Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals’ services and social services were measured throughout the study.

Results: Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24.

Conclusions: In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early.

Introduction

During the last few years there have been increasing numbers of publications showing that the prevalence of malnutrition varies from between 20% and 40% in patients in hospital,1., 2., 3. and is approximately 10% in patients in the community.4., 5.

Malnutrition can result in increased infection rates,6 increased length of hospital stay,7 delayed wound healing,8 reduced appetite and increased mortality rates.9 It has also been shown that in patients with cancer, chronic diseases and cardiovascular disease in the community,10., 11. there is a relationship between nutritional status and use of health-care resources. Patients with these diseases who also have a low body mass index (BMI), have increased requirements for prescription drugs, visits to the general practitioner and hospital admissions and higher mortality rates.11., 10. Beattie and Pennington.12 have shown that post-surgical patients lose significant amounts of weight in hospital, that this weight loss continues after discharge, but it can be reversed with supplementation with a concomitant improvement in quality of life.

Despite this scientific evidence, general practitioners may be reluctant to prescribe nutritional support for patients in the community because of the burden on their budgets. Many argue that malnutrition results from severity of disease, and it is this, rather than malnutrition, which increases patients’ requirements for health-care resources. We have conducted a randomised, prospective controlled trial to determine whether providing short-term supplemental nutrition to a heterogeneous group of elderly malnourished patients after discharge from hospital improves body weight and hence BMI, and handgrip strength, a functional measure of overall strength.13 An additional objective was to determine if supplemental nutrition improves quality of life and mortality rates, or reduces the numbers of prescriptions and other health-care resources required by malnourished patients who receive supplements when compared with those who do not.

This multi-centre prospective open label, randomised controlled trial was conducted between October 2000 and September 2001 in four hospitals. The study was approved by the Local Research Ethics Committee of each of the trusts participating in the study.

Subjects were eligible for entry if they were ⩾65 years and were to be discharged from hospital with either (i) a BMI < 20, or (ii) BMI ⩾20 but <25 with documented evidence of weight loss of ⩾10% of their body weight in the 6 months prior to the study period or ⩾5% in the 3 months prior to the study period. Subjects were also required to score ⩾7 on the Abbreviated Mental Test.

Subjects were excluded if they were incapable of taking study supplements to provide a minimum of 600 kcal/day in addition to usual food intake, could not stand to be weighed, were intolerant to any of the ingredients in the study supplements, had a history of diabetes, hyperglycaemia or chronic renal failure, required total parenteral nutrition or enteral feeds as sole source of nutrition or had been prescribed supplements during the last week of their hospital stay.

Potential study subjects were screened by an investigator (dietitian) in each hospital. Subjects who were identified as being malnourished as described above, fulfilled all entry criteria and gave written informed consent, were entered into the study. The baseline visit was carried out in the hospital or in the patient's home within 72 h before Study Day 1. Baseline measurements included demography, medical history including reason for hospitalisation and length of hospital stay, body weight and height, mid-arm circumference (MAC) and triceps skinfold thickness (TST). BMI was calculated from the formula: BMI=weight (kg)/height2 (m2). Mid arm muscle circumference (MAMC) was calculated from the formula: MAMC (cm)=MAC (cm) −3.14×TST (cm). Muscle strength was measured using Handgrip Dynamometry and quality of life was assessed using the EuroQol Questionnaire (EQ5D).14., 15. The number of drugs and the name of each drug prescribed in the 7 days prior to discharge and those prescribed on discharge from hospital were also recorded.

At the baseline visit, eligible subjects were randomised to intervention or control (i.e. standard of care, which means that patients do not routinely receive nutritional supplements on discharge) using envelopes prepared by the statistician. The energy and protein requirements of each individual were estimated by the dietitian using the Schofield equation.16., 17. Supplement intakes of between 600 and 1000 kcal/day were prescribed, using the appropriate factors(s) to correct for each subject's clinical condition, for those in the intervention group in order to increase energy and protein intake to achieve a weight gain of at least 0.5 kg/week. These subjects were given a choice of one or more nutritional supplements (Ensure Plus ®tetrapak, Enlive®tetrapak, Formance® Pudding or Ensure Bar®, Abbott Laboratories Ltd, Maidenhead). Although these supplements have different nutrient compositions, the objective was to increase subjects’ energy and macronutrient intake overall and to help to improve compliance by minimising taste fatigue. It was intended that these subjects should receive supplements for the first 8 weeks of the study, but those who wished to continue for longer were encouraged to do so if the dietitian felt it was appropriate. Throughout the study, the dietitian actively encouraged the subjects in the intervention group to take their supplements by telephoning them regularly between visits and suggesting innovative ways to incorporate them into their daily diet without compromising food intake. Subjects in the control group received no nutritional intervention and ate their usual meals at home after discharge.

Supplements were supplied to subjects in the intervention group at the initial visit and at weeks 1, 4, and 8 if supplementation was required after week 8. Subjects in both the intervention and control groups were provided with a diary card and asked to record any visits from, or requirements for, social services or health-care professionals’ services throughout the study. These included consultations with their general practitioner (GP) either at home or at the surgery, district nurse visits, visits to the GP practice, hospital admissions, outpatient visits and requirements for NHS carers, home help or meals on wheels. Subjects in the intervention group were provided with an additional diary in which they were asked to record daily the amount and type of supplement taken. Compliance was assessed using this diary and by monitoring the numbers of supplements the subject did not take. Adverse events were recorded throughout the study.

Study Day 1 occurred within 7 days after discharge from hospital and was defined as the first day of supplementation for the intervention group, and the first day the subject filled in a diary card for the control group. Subjects in both groups were visited by the dietitian at home at the end of the first week, then at weeks 4, 8, 12 and 24. At the end of the first week and at week 12, all subjects completed a 3-day dietary diary. These were analysed using MICRODIET or similar programmes, which are all based on the food composition data from McCance and Widdowson's ‘The Composition of Foods’,18 to calculate macronutrient and micronutrient intake. At week 4, the energy requirements of the subjects in the intervention group were reassessed and supplement intake adjusted if necessary. At week 8, all subjects were weighed and BMI calculated. For subjects in the intervention group who continued to take supplements, energy requirements were reassessed and supplement intake adjusted as required. Muscle strength was measured in both groups using handgrip dynamometry.

At week 12 and the final visit (week 24), all subjects were weighed, BMI calculated and anthropometric measurements taken. Muscle strength was measured using handgrip dynamometry. In addition, the EQ5D assessment of quality of life was administered to all subjects.

After the last visit, a retrospective review of the subjects’ GP notes was conducted to determine the nature and number of health-care resources the patient had used during the 24 week study period and the 24 weeks prior to the study. This included the number of prescriptions, number of visits to the GP or house calls from the GP, and the number of hospital admissions and outpatient visits. In addition, if the patient had been re-admitted to hospital during the study period, the notes were reviewed to determine length of stay.

Section snippets

Sample size calculation

The sample size calculation was based on a previous study which showed that following 8 weeks of supplemental feeding, patients had a mean increase in body weight of approximately 4 kg compared with the control group, and that the standard deviation for the change in body weight was approximately 4.5 kg.12 We aimed to recruit approximately 48 subjects per treatment group to detect a difference in mean change in body weight of 3 kg between subjects who received supplemental feeding and those who

Results

Six hundred and 19 subjects were eligible for entry into the study. Five hundred and 19 did not participate for the following reasons: 391 refused consent, 30 were too ill, 38 were discharged before informed consent could be obtained, 56 were excluded because they scored <7 on the Abbreviated Mental Test, one was participating in another study, and three died before informed consent could be obtained. One hundred subjects entered the study, 55 women, 45 men, mean age 78 years, range 65–95

Discussion

In this randomised controlled trial of nutritional supplementation in a heterogeneous group of undernourished elderly subjects, we found that body weight, BMI and TST, increased significantly over the course of the study in the intervention group. These changes in anthropometric indices occurred throughout the course of the study despite the fact that the period of supplementation was only 8 weeks. There were no significant increases in these variables in the control group and no significant

Acknowledgements

This study was funded by Abbott Laboratories, Maidenhead, Berkshire, SL6 4XE, UK.

References (20)

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