ORAL LIQUID NUTRITIONAL SUPPLEMENTS FOR PEOPLE WITH DEMENTIA IN RESIDENTIAL AGED CARE FACILITIES

ORAL LIQUID NUTRITIONAL SUPPLEMENTS FOR PEOPLE WITH DEMENTIA IN RESIDENTIAL AGED CARE FACILITIES SYSTEMATIC REVIEW PROTOCOL August 2007 Reviewers: Prof Jenny Abbey Deborah Parker Jacinda Wilson* Dementia Collaborative Research Centre Consumers, Carers and Social Research Queensland University of Technology (QUT) School of Nursing N610 Kelvin Grove 148 Victoria Park Road Kelvin Grove QLD 4059 AUSTRALIA *Corresponding author Ph: +617 3138 3852 Email: jacinda.wilson@qut.edu.au

OBJECTIVES The overall objective is to establish best practice in relation to oral liquid nutritional supplements for people with dementia living in residential aged care facilities. 1. To establish factors associated with the prescription and administration of oral liquid nutritional supplements for people with dementia living in RACFs 2. To assess the effectiveness of administering oral liquid nutritional supplements for people with dementia living in RACFs on mortality, morbidity, functional and nutritional status, and economic outcomes 3. To identify what the attitudes are of people with dementia in RACFs and their family carers regarding the administration of oral liquid nutritional supplements 4. To identify what the attitudes are of staff regarding the administration of oral liquid nutritional supplements for people with dementia in RACFs BACKGROUND Older people with dementia living in RACFs are at increased risk of malnutrition [1]. Malnutrition may be due to many factors, including difficulty in choosing food, transferring to the mouth and chewing, [2] and behavioural symptoms such as agitation/aggression and irritability/lability [3]. Poor nutrition is associated with many negative outcomes, including poor skin integrity (such as pressure ulcer development and compromised wound healing), dehydration, pneumonia, falls and urinary tract infections [1]. There are different forms of dementia and each has its own causes. Dementia is an umbrella term for a large group of conditions that cause a progressive decline in a person s functioning. This review will include Alzheimer s disease, vascular dementia, frontotemporal dementia, dementia with Lewy bodies, Wernicke Encephalopathy, Creutzfeldt-Jakob Syndrome, Korsakoff Syndrome [4]. In an effort to optimise nutrient intake, residents may be prescribed an oral liquid nutritional supplement (OLNS). Commercially available liquid supplements include milk type supplements (e.g. Entera, Build-Up ) and juice-type supplements (e.g. Enlive, Resource ). However the supplements are not always well accepted by residents and may be only partially consumed, if at all. Nolan [5] measured the volume of liquid supplements wasted in their study conducted in elderly and rehabilitation wards, and estimated that on average 41% (range 35-63%) of Enlive and 44% (range 31-63%) of Entera supplements issued were wasted. From their study conducted with older patients in an acute setting, Ross [6] reported that oral sip feed supplements were refused in 32% of cases. Reasons for non compliance with OLNS orders vary. Questionnaires were completed by 16 patients in Gosney s [7] study, of which 56% stated they did not like sip feeds, 25% reported disliking the taste, 19% disliked the texture, 38% disliked the sweetness and 19% reported feeling sick or bloated after drinking them. Issues regarding tolerance and side effects were also identified and were reported in five of the studies included in Milne et al. s [8] 2004 systematic review, which investigated protein and energy supplementation in older people at risk of malnutrition. This review was not dementia-specific, and included older people living in all settings. Supplementation was not found to be the preferred nutritional intervention in a study by Simmons et al. [9]. The authors interviewed family members of residents in skilled nursing facility, and provision of OLNS was rated the fifth most desirable preference, out of six options. More desirable nutritional approaches were improvement in food quality, better feeding assistance, providing snacks and seating the resident in a dining setting. Wastage of OLNS has financial implications. Gosney [7] reported that over a 24 hour period, the mean wastage of sip feeds given to 96 older patients of four hospital

wards was 63%. Using data collected over a 24 hour period from observing the 96 patients, the authors extrapolated that _18, 294 per annum was wasted in the four wards, on OLNS that were not drunk. Welch et al. [10] reported significantly less (p<0.001) wastage in OLNS intake when a medication pass supplement program was implemented in a nursing home. They estimated that providing OLNS at the same time as medications were distributed led to significant increases in prealbumin levels (p <0.03) and significant difference in the cost of supplement wastage (p<0.001). In a conference poster, Kerrigan et al. [11] also reported cost savings from their study conducted in a nursing home, which trialled dispensing OLNS in parallel with the routine medication pass. Research findings into the effectiveness of OLNS have been mixed. An issue pertinent to the effectiveness or otherwise of OLNS is whether they truly do only supplement food intake, or whether they replace it, and thereby become counterproductive. That is, some researchers have expressed concern that providing supplements between meals may fill residents up, so they are less able to attempt consuming normal food. A Certified Nursing Assistant (CNA) in a five year study conducted by Kayser Jones et al. [12] reported that if residents drank an OLNS at 10am, they were not hungry at lunchtime, and residents and family members expressed similar concerns. Kayser-Jones et al. also found inadequate staffing levels impacted on whether supplements replaced food, as some staff in the study reported that they found it quicker to give residents a can of OLNS, than to spend time feeding them. [12] The systematic review by Milne et al. [8] suggested that supplementation can have a beneficial effect on mortality, however found little evidence to suggest supplementation leads to improved clinical outcome or functional benefit in older people at risk of malnutrition. In addition to including literature published since the Milne et al. review (i.e. post March 2004), the current proposed systematic review will differ by restricting the population and setting of interest to only people with dementia living in RACFs. A limitation reported by Milne et al. [8] was the possibility that because participants were part of trials, they possibly received more assistance (e.g. encouragement offered, physical help etc) than what may be given in real life practice. As such, the current review will include qualitative studies which investigate factors pertaining to the prescription and administration of OLNS in RACFs. CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW Types of participants The review will consider studies that included people with dementia living in RACFs who are receiving oral liquid nutritional supplements. The nutritional status of participants (i.e. undernourished or otherwise) and how this has been assessed will be recorded, where available. Types of interventions This review will consider studies that include the oral administration of liquid supplements aimed at improving the intake of protein and energy. These may be: juice based supplements or milk based supplements These may be reported as sip feeds or liquid food. Studies which investigate vitamin and/or mineral supplements only will not be included in this review. Types of outcome measures

This review will consider studies that include outcomes relating to the effectiveness of oral liquid nutritional supplements administered to people with dementia in RACFs: Mortality Morbidity, number of people with complications (pressure sores, deep vein thrombosis, falls, respiratory and urinary infections) Functional status (cognitive functioning, muscle functioning, mobility, ability to perform activities of daily living) Nutritional status (change in anthropometry) Economic outcomes Outcomes relating to the prescription and administration of oral liquid nutritional supplements to people with dementia in RACFs: Factors associated with the prescription and administration of oral liquid nutritional supplements to people with dementia living in RACFs Resident s and carers attitudes regarding the administration of oral liquid nutritional supplements Staff attitudes regarding the administration of oral liquid nutritional supplements Types of studies To investigate questions relating to the effectiveness of oral liquid nutritional supplements administered to people with dementia in RACFs: randomised control trials, quasi-experimental studies, cohort studies, case control studies and observational studies without control group will be considered. To investigate questions relating to the prescription and administration of oral liquid supplements to people with dementia in RACFs: Descriptive studies, qualitative studies (including ethnographies, phenomenologies, grounded theory studies) and discussion papers. In the absence of these, opinion papers, or reports that meet with inclusion criteria will be considered. Language Only studies reported in English will be considered for inclusion. SEARCH STRATEGY The search strategy aims to identify both published and unpublished studies, reported in English. A three-step strategy will be followed, in which the initial phase will consist of searches of the CINAHL, Medline and PsycINFO databases using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group. Secondly, a more extensive search will be performed using the appropriate Subject Headings and/or keywords/phrase/strategy for each of the databases listed below. Finally, the reference lists of identified reports and articles will be hand searched for additional studies. Databases Searches will be conducted from 1995 to current. The databases to be searched include: PsycARTICLES Ageline EMBASE APAIS Health Current Contents Dissertation and Thesis Abstracts

Social Science Citation Index Sociological Abstracts NHMRC guidelines Pre-Cinahl Cochrane Controlled Trials Register (CCTR) Cochrane Central Register of Controlled Trials (CENTRAL) International Bibliographic Information on Dietary Supplements (IBIDS) database Health & Society National Rehabilitation and Information Centre (NARIC) Meditext Hand searching Hand searching will be conducted through the following specialised relevant journals that are not indexed in the electronic databases: Dementia: International Journal of Social Research and Practice SIGNPOST - Journal of Dementia and Mental Health for Older People Anthropology of Food Dietary Supplement and Food Labelling News Food Quality and Preference Food Science and Technology International Journal of Nutritional Medicine Nutrition Abstracts Nutrition Clinics (absorbed by Topics in Clinical Nutrition) Perspectives in Food and Nutrition Perspectives: Nutrition News and Views Grey literature The grey literature search will consist of: searching reference lists of included articles contacting authors who may be knowledgeable about the phenomena of interest to attempt to identify further published, un-published or ongoing studies conducting a computer search of within databases and websites including, but not limited to, the following: o Google Scholar o PsycEXTRA o National Institute of Clinical Studies o Australian Centre for Evidence Based Clinical Practice (http://www.acebcp.org.au) o Alzheimer's Disease Education and Referral Centre Clinical Trials Database host: Food and Drug Administration and the National Institute on Aging (http://www,alzheimers.org/trials/index.html) o National Institutes of Health (NIH) Clinical Trials Database host: NIH (http://clinicaltrials.gov/ct) o National Institute of Clinical Studies (http://www.med.monash.edu.au/healthservices/cce/index.html

Initial keywords Initial keywords include, but will not be limited to: DELIRIUM DEMENTIA MALNUTRITION PROTEIN ENERGY MALNUTRITION (CINAHL Heading, MeSH) DIETARY SUPPLEMENTS (covers food supplements as well in CINAHL) Alzheimer* disease Creutzfeldt-Jakob syndrome Lewy Body Disease Wernicke Encephalopathy Korsakoff Syndrome METHODS OF THE REVIEW Data retrieval All studies identified by the database searches will be assessed for relevance to the review based on the title and abstract. For studies that appear to meet the inclusion criteria, the full paper will be retrieved and will be assessed for relevance to the review criteria. Criteria on which quality of studies will be assessed Quantitative studies will be assessed by two independent reviewers for methodological quality prior to inclusion in the review using the appraisal checklist instrument developed by the Joanna Briggs Institute (JBI) and based on the work of the Cochrane Collaboration and Centre for Reviews and Dissemination (Appendix 1). Data from qualitative studies will be assessed using the Qualitative Assessment and Review Instrument (JBI-QARI) data extraction tool developed by JBI (Appendix 2). Conclusions/recommendations from opinion papers, discussion papers and letters will be extracted using the Narrative, Opinion and Text Assessment and Review Instrument (JBI-NOTARI) data extraction tool developed by JBI (Appendix 3). Any disagreements that arise between the reviewers will be resolved by the third reviewer. Data extraction Data from quantitative studies will be extracted using a data extraction tool developed by JBI (Appendix 4). Data from qualitative studies will be extracted using JBI-QARI (Appendix 5) and conclusions/recommendations from non-research papers (such as opinion papers, discussion papers and letters) will be extracted using JBI- NOTARI (Appendix 6). Data synthesis For quantitative studies, where possible, odds ratio (for categorical outcome data) or standardised mean differences (for continuous data) and their 95% confidence intervals will be calculated for each included study. If appropriate with available data, results from comparable groups of studies will be pooled in statistical meta-analysis using Review Manager (RevMan) software from the Cochrane Collaboration. Heterogeneity between combined studies will be tested using standard chi-square test. Where statistical pooling is not appropriate or possible, the findings will be summarised in narrative form. For qualitative studies, where possible, data will be synthesised using JBI-QARI. Where synthesis is not possible or appropriate, the findings will be summarised in a narrative, listing significant factors or themes. Conclusions/recommendations from

non-research papers (such as opinion papers, discussion papers and letters), will be synthesised using JBI-NOTARI. Potential conflict(s) of interest None known. Acknowledgments This systematic review is being funded by the Dementia Collaborative Research Centre Consumers, Carers and Social Research under the Commonwealth Government s Dementia a National Health Priority Initiative. The reviewers acknowledge Dr Angela Vivanti, Research and Development Dietician (Department of Nutrition and Dietetics, Princess Alexandra Hospital), Professor Lynne Daniels, Nutrition and Dietetics (Research), Queensland University of Technology and Professor Anne Chang (Nursing Research), Director The Queensland Centre for Evidence Based Nursing & Midwifery, Mater Health Services for their comments on the protocol.

REFERENCES [1] Stratton RJ, Green CJ, Elia M. Disease-related malnutrition: an evidencebased approach to treatment. Oxon UK: CABI Publishing 2003. [2] Berkhout A, Cools H, Houwelingen HV. The relationship between difficulties in feeding oneself and loss of weight in nursing-home patients with dementia. Age and Ageing. 1998;27(5):637-42. [3] White HK, McConnell ES, Bales CW, Kuchibhatla M. A 6-month observational study of the relationship between weight loss and behavioural symptoms in institutionalised Alzheimer's disease subjects. Journal of the American Medical Directors Association. 2004;5:89-97. [4] Alzheimer's Australia. Dementia Terminology Framework; 2004 Position Paper 4. [5] Nolan A. Audit of supplement use on care of the elderly and rehabilitation wards. Journal of Human Nutrition and Dietetics. 1999;12:453-8. [6] Ross F. An audit of nutritional supplement distribution and consumption on a care of the elderly ward. Journal of Human Nutrition and Dietetics. 1999;12:445-52. [7] Gosney M. Are we wasting out money on food supplements in elder care wards? Journal of Advanced Nursing. 2003;43(3):275-80. [8] Milne A, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition: Cochrane Database of Systematic Reviews; 2005. Report No.: Issue 1. [9] Simmons SF, Patel AV. Nursing home staff delivery of oral liquid nutritional supplements to residents at risk for unintentional weight loss. Journal of the American Geriatrics Society. 2006;54:1372-6. [10] Welch P, Porter J, Endres J. Efficacy of a medication pass supplement program in long-term care compared to a traditional system. Journal of Nutrition for the Elderly. 2003;22(3):19-28. [11] Kerrigan ES, Maxwell J, Siegel C. Dispensing of a calorically dense oral supplement with medication pass: A creative approach to oral supplementation. Journal of the American Dietetic Association. 1996;96(9 (supp)):a32. [12] Kayser-Jones J, Schell E.S, Porter C, Barbaccia J.C, Steinbach C, Bird WF, et al. A prospective study of the use of liquid dietary supplements in nursing homes. Journal of the American Geriatrics Society. 1998;46:1378-86.

Appendix 1 Critical Appraisal of Evidence of Effectiveness Reviewer Date Author Year Record No 1. Was the assignment to treatment groups random? 2. Were the participants blinded to treatment allocation? 3. Was allocation to treatment groups concealed from the allocator? 4. Were the outcomes of people who withdrew described and included in the analysis? 5. Were those assessing the outcomes blind to the treatment allocation? 6. Were control and treatment groups comparable at entry? 7. Were groups treated identically other than for the named interventions? 8. Were outcomes measured in the same way for all groups? 9. Were outcomes measured in a reliable way? 10. Was there adequate follow-up of participants (>80%)? 11. Was appropriate statistical analysis used? Overall appraisal: Include Exclude Seek further info Comments (including reasons for exclusion

Appendix 2 JBI-QARI Critical Appraisal Form Criteria Yes No Unclear 1) There is congruity between the stated philosophical perspective and the research methodology 2) There is congruity between the research methodology and the research question or objectives 3) There is congruity between the research methodology and the methods used to collect data 4) There is congruity between the research methodology and the representation and analysis of data 5) There is congruity between the research methodology and the interpretation of results 6) There is a statement locating the researcher culturally or theoretically 7) The influence of the researcher on the research, and vice-versa, is addressed 8) Participants, and their voices, are adequately addressed 9) The research is ethical according to current criteria or, for recent studies, there is evidence of ethical approval by an appropriate body 10) Conclusions drawn in the research report do appear to flow from the analysis, or interpretation, of the data TOTAL Reviewers Comments:

Appendix 3 JBI-NOTARI critical appraisal FORM Criteria Yes No Unclear 1) Is the source of the opinion clearly defined? 2) Does the source of the opinion have standing in the field of expertise? 3) Are the interests of the patients/clients the central focus of opinion? 4) Is the opinion s basis in logic/experience clearly argued? 5) Is the argument developed analytical? 6) Is there reference to the extant literature/evidence and any incongruence with it logically defended? 7) Is the opinion supported by peers? Include: Yes / No Reason:

Appendix 4 JBI Data Extraction Form for Experimental/Observational Studies Reviewer Date Author Year Record No Study Method RCT Quasi RCT Longitudinal Participants Retrospective Observational Other Setting Population Sample size Intervention1 Intervention 2 Intervention 3 Interventions Intervention1 Intervention2 Intervention 3 Clinical Outcome Measures Outcome Description Scale/measure

Study results Dichotomous data Outcome Intervention ( ) Number/total number Intervention ( ) Number/total number Continuous data Outcome Intervention ( ) Mean and SD (number) Intervention ( ) Mean and SD (number) Author conclusions Reviewer conclusions /comments Include Exclude Seek further info

Appendix 5 JBI-QARI Data Extraction Form Qualitative Data Extraction Tool Author: Record Number: Journal: Year: Reviewer: Methodology Method Data Analysis Setting & Context Geographical Context Cultural Context Participants: Number: Description: Phenomena of Interest

Findings Narrative Description Qual Evid. Rating 1,2,3 Authors conclusion Comments

Appendix 6 JBI-NOTARI Data Extraction Tool Type of text: Those represented: Stated allegiance/position: Setting: Geographical: Cultural: Logic of argument: Data analysis: Author s conclusion: Reviewers Comments: