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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Research

A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

Authors: Ruth Stow, Natalie Ives, Christina Smith, Caroline Rick, Alison Rushton

Published in: Trials | Issue 1/2015

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Abstract

Background

Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken.

Methods

Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months.

Results

All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC.

Conclusions

A definitive trial comparing the efficacy of nutritional support interventions in increasing weight and BMI in malnourished care home residents can be conducted. However, whilst the design was feasible, this trial has highlighted the lack of clinically and patient-relevant outcome measures that are appropriate for use in this setting for both research and clinical practice. In particular, this trial identified a need for a more simple measure of functional status, which considers the limitations of functional tests in the care home population.

Trial registration

Current Controlled Trials ISRCTN38047922, Date assigned: 22 April 2014.
Appendix
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Literature
1.
Hoffer LJ. Metabolic consequences of starvation. In: Shils ME, Olson JA, Shike M, et al., editors. Modern nutrition in health and disease. Baltimore: Williams & Wilkins; 1999. p. 645–66.
2.
Correia M, Waitzberg D. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through multivariate model analysis. Clin Nutr. 2003;22:235–9.CrossRefPubMed
3.
McWilliams B. Assessing the benefits of a malnutrition screening tool. Nurs Times. 2008;104:30–1.
4.
5.
6.
7.
Cowan DT, Roberts JD, Fitzpatrick JM, While AE, Baldwin J. Nutritional status of older people in long term care settings: current status and future directions. Int J Nurs Stud. 2004;41:225–37.CrossRefPubMed
8.
Arvanitakis M, Coppens P, Doughan L, Van Gossum A. Nutrition in care homes and home care: Recommendations- a summary based on the report approved by the Council of Europe. Clin Nutr. 2009;28:492–6.CrossRefPubMed
9.
Meijers J, Halfens RJ, Wilson L, Schols JM. Estimating the costs associated with malnutrition in Dutch nursing homes. Clin Nutr. 2012;31:65–8.CrossRefPubMed
10.
Baldwin C, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2011;9:CD00200.
11.
12.
13.
Prickett J. Oral Nutrition support. In: Thomas B, Bishop J, editors. Manual of Dietetic Practice. 4th ed. London: Blackwell Publishing; 2011. p. 91–6.
14.
15.
Odlund OA, Armyr I, Soop M, Jerstrom S, Classon I, Cederholm T, et al. Energy-dense meals improve energy intake in elderly residents in a nursing home. Clin Nutr. 2003;22:125–31.CrossRef
16.
Smoliner C, Norman K, Scheufele R, Hartig W, Pirlich M, Lochs H. Effects of food fortification on nutritional and functional status in frail elderly nursing home residents at risk of malnutrition. Nutrition. 2008;24:1139–44.CrossRefPubMed
17.
Hobday R. Appropriate prescribing of oral nutritional supplements: A challenge and opportunity for dietitians. Diet Today. 2010;6:28–30.
18.
19.
20.
Stratton RJ, Green CJ, Elia M. Disease-related malnutrition: an evidence- based approach. Oxford: CABI Publishing; 2003.
21.
Milne AC, Avenell A, Potter J. Oral protein and energy supplementation in older people: a systematic review of randomized trials. Nestle Nutr Workshop Ser Clin Perform Programme. 2005;10:103–20.CrossRefPubMed
22.
Koretz RL, Avenell A, Lipman TO, Braunschweig CL, Milne AC. Does enteral nutrition affect clinical outcome? A systematic review of the randomized trials. Am J Gastroenterol. 2007;102:412–29.CrossRefPubMed
23.
Milne AC, Potter J, Vivanti A, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2009;2:CD003288.PubMed
24.
Maas M, Kelley L, Park M, Specht JP. Issues in conducting research in nursing homes. West J Nurs Res. 2002;4:373–89.CrossRef
25.
Collingridge Moore D, Hanratty B. Out of sight, out of mind? A review of data available on the health of care home residents in longitudinal and nationally representative cross-sectional studies in the UK and Ireland. Age Ageing. 2013;28:17–7.
26.
Fiatarone Singh MA, Bernstein MA, Ryan AD, O'Neill EF, Clements KM, Evans WJ. The effect of oral nutritional supplements on habitual dietary quality and quantity in frail elders. J Nutr Health Aging. 2000;4:5–12.PubMed
27.
Manders M, de Groot CP, Blauw YH, Dhonukshe-Rutten RA, van Hoeckel-Prüst L, Bindels JG, et al. Effect of a nutrient-enriched drink on dietary intake and nutritional status in institutionalized elderly. Eur J Clin Nut. 2009;63:1241–50.CrossRef
28.
Lee LC, Tsai AC, Wang JY. Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: A randomized controlled trial. Int J Nurs Stud. 2013;50:1580–8.CrossRefPubMed
29.
Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and metaanalyses: the PRISMA Statement. Ann Intern Med. 2009;151:264–9.CrossRefPubMed
30.
Elia M. The ‘MUST’ report. Nutritional screening for adults: a multidisciplinary responsibility. Redditch: BAPEN; 2003.
31.
Department of Health. Mental Capacity Act 2005. Department of Health. 2005. http://​www.​dh.​gov.​uk/​en/​Publicationsands​tatistics/​Publications/​PublicationsPoli​cyAndGuidance/​DH_​4137745.​Accessed 7 February 2013
32.
33.
34.
Stratton RJ, Elia M. Who benefits from nutritional support: what is the evidence? Eur J Gastroenterol Hepatol. 2007;19:353–8.CrossRefPubMed
35.
Department of Health. The Nutrition of Elderly People. Report of the Working Group on the Nutrition of Elderly People of the Committee on Medical Aspects of Food Policy: No. 43. London: HMSO; 1992.
36.
37.
Schulz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002;359:781–5.CrossRefPubMed
38.
Care Quality Commission (CQC). Guidance about compliance: Essential standards of quality and safety. London: CQC; 2010.
39.
Bruno de Carvalho-Silva L. Nutritional Care in Amyotrophic Lateral Sclerosis: An Alternative for the Maximization of the Nutritional State. In: Maurer MH, editor. Amyotrophic Lateral Sclerosis. Rijeka: InTech; 2012. p. 595–612.
40.
Powell-Tuck J, Hennessey EM. A comparison of mid upper arm circumference, body mass index and weight loss as indices of undernutrition in acutely hospitalized patients. Clin Nutr. 2003;22:307–12.CrossRefPubMed
41.
Harris DG, Davies C, Ward H, Haboubi NY. An observational study of screening for malnutrition in elderly people living in sheltered accommodation. J Hum Nutr Diet. 2008;21:3–9.CrossRefPubMed
42.
Wang J, Thornton JC, Kolesnik NS, Pierson Jr RN. Anthropometry in body composition: an overview. Ann N Y Acad Sci. 2000;904:317–26.CrossRefPubMed
43.
44.
Sallinen J, Stenholm S, Rantanen T, Heliövaara M, Sainio P, Koskinen S. Hand-grip strength cut points to screen older persons at risk for mobility limitation. J Am Geriatr Soc. 2010;58:1721–6.CrossRefPubMedPubMedCentral
45.
Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practice. NEJM. 1977;296:716–21.CrossRefPubMed
46.
Brazier J, Roberts J, Tsuchiya A. A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ. 2004;13:873–84.CrossRefPubMed
47.
Rabin R, De Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–43.CrossRefPubMed
48.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011;20:1727–36.CrossRefPubMedPubMedCentral
49.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes relat Metab Disord. 2000;24:38–48.CrossRefPubMed
50.
Parker BA, Sturm K, MacIntosh CG, Feinle C, Horowitz M, Chapman IM. Relation between food intake and visual analogue scale ratings of appetite and other sensations in healthy older and young subjects. Eur J Clin Nutr. 2004;58:212–8.CrossRefPubMed
51.
Jenkinson C, Lawrence K, McWhinnie D, Gordon J. Sensitivity to change of health status measures in a randomised controlled trial: a comparison of the Dartmouth COOP charts and the SF-36. Qual Life Res. 1995;4:47–52.CrossRefPubMed
52.
McHorney CA, Ware JE, Rogers W, Raczek AE, Lu JF. The validity and relative precision of MOS short and long form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study. Med Care. 1992;30:253–65.CrossRef
53.
Arain M, Campbell MJ, Copper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.CrossRefPubMedPubMedCentral
54.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10:307–12.CrossRefPubMed
55.
56.
Eldridge SM, Ukoumunne OC, Carlin JB. The Intra-Cluster Correlation Coefficient in Cluster Randomized Trials: A Review of Definitions. Int Stat Rev. 2009;77:378–94.CrossRef
57.
Donner A, Piaggio G, Villar J. Meta-analyses of cluster randomization trials: Power considerations. Eval Health Prof. 2003;26:340–51.CrossRefPubMed
58.
Killip S, Mahfoud Z, Pearce K. What is an Intracluster Correlation Coefficient? Crucial Concepts for Primary Care Researchers. Ann Fam Med. 2004;2:204–8.CrossRefPubMedPubMedCentral
59.
Cresswell JW. Research Design, Qualitative, Quantitative and Mixed Method Approaches. 3rd ed. Thousand Oaks: Sage Publications; 2009.
60.
Murray DM, Catellier DJ, Hannan PJ, Treuth MS, Stevens J, Schmitz KH, et al. School level intraclass correlation for physical activity in adolescent girls. Med Sci Sports Exerc. 2004;36:876–82.CrossRefPubMedPubMedCentral
61.
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomised trials. Intl J Epidemiol. 1999;28:319–26.CrossRef
62.
Parsons EL, Elia M, Cawood AL, Smith TR, Warwick H, Stratton RJ. Randomised controlled trials shows greater total nutritional intakes with liquid supplements than dietary advice in care home residents. Clin Nutr. 2011;6:31.
63.
Donner A, Klar N. Methods for comparing event rates in intervention studies when the unity of allocation is a cluster. Am J Epidemiol. 1994;140:279–89.PubMed
64.
Detsky A, McLaughlin J, Baker J. What is subjective global assessment of nutritional status. J Parenter Enter Nutr. 1987;11:8–13.CrossRef
65.
Hubbard GP, Elia M, Holdoway A, Stratton RJ. A systematic review of compliance to oral nutritional supplements. Clin Nutr. 2012;31:293–312.CrossRefPubMed
66.
Simmons SF, Reuben D. Nutritional intake monitoring for nursing home residents: a comparison of staff documentation, direct observation, and photography methods. J Am Geriatr Soc. 2000;48:209–13.CrossRefPubMed
67.
Castellanos VH, Andrews YN. Inherent flaws in a method of estimating meal intake commonly used in long-term care facilities. J Am Diet Assoc. 2002;102:826–30.CrossRefPubMed
68.
Wijnhoven HAH, de Boer MR, van Maanen MJ, van Dongen DM, Kraaij SF, Smit T, et al. Reproducibility of measurements of mid-upper arm circumference in older persons. J Hum Nutr Diet. 2013;26:24–31.CrossRefPubMed
69.
Ulijaszek SJ, Kerr DA. Anthropometric measurement error and the assessment of nutritional status. Br J nutr. 1999;82:165–77.CrossRefPubMed
70.
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, et al. Sarcopenia: European consensus on definition and diagnosis: report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010;39:412–23.CrossRefPubMedPubMedCentral
71.
Hoppitt T, Sackley C, Wright C. Finding the right outcome measures for care home research. Age Ageing. 2010;39:119–22.CrossRefPubMed
72.
Stange I, Bartramb M, Liao YB, Poeschl K, Kolpatzik S, Uter W, et al. 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. 2012;14:628. e1-8.
73.
Turic A, Gordon KL, Craig LD, Ataya DG, Voss AC. Nutrition supplementation enables elderly residents of long term care facilities to meet or exceed RDAs without displacing energy or nutrient intakes from meals. J Am Diet Assoc. 1998;98:1457–9.CrossRefPubMed
74.
Iuliano S, Woods J, Robbins J. Consuming two additional serves of dairy food a day significantly improves energy and nutrient intakes in ambulatory aged care residents: A feasibility study. J Nutr Health Aging. 2013;17:509–13.CrossRefPubMed
75.
Kwok T, Woo J, Kwan M. Does low lactose milk powder improve the nutritional intake and nutritional status of frail older Chinese people living in nursing homes? J Nutr Health Aging. 2001;5:17–21.PubMed
76.
Leslie WS, Woodward M, Lean MEJ, Theobald H, Watson L, Hankey CR. Improving the dietary intake of under nourished older people in residential care homes using an energy-enriching food approach: a cluster randomised controlled study. J Hum Nutr Diet. 2013;26:387–94.CrossRefPubMed
77.
Lauque S, Arnaud-Battandier F, Mansourian R, Guigoz Y, Paintin M, Nourhashemi F, et al. Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Age Agein. 2000;29:51–6.CrossRef
78.
Wouters-Wesseling W, Wouters AE, Kleijer CN, Bindels JG, de Groot CP, van Staveren WA. Study of the effect of a liquid nutrition supplement on the nutritional status of psycho-geriatric nursing home patients. Eur J Clin Nutr. 2002;56:245–51.CrossRefPubMed
79.
Miller MD, Crotty M, Giles LC, Bannerman E, Whitehead C, Cobiac L, et al. Corrected arm muscle area: an independent predictor of long-term mortality in community-dwelling older adults? J Am Geriatr Soc. 2002;50:1272–7.CrossRefPubMed
80.
Warburton D, Gledhill N, Quinney A. The effects of changes in musculoskeletal fitness on health. Can J Appl Physiol. 2001;26:161–216.CrossRefPubMed
81.
Paterson D, Govindasamy D, Vidmar M, Cunningham DA, Koval JJ. Longitudinal study of determinants of dependence in an elderly population. J Am Geriatr Soc. 2004;52:1632–8.CrossRefPubMed
82.
Metadata
Title
A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents
Authors
Ruth Stow
Natalie Ives
Christina Smith
Caroline Rick
Alison Rushton
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0952-2

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