Randomised controlled trial of welfare rights advice accessed via primary health care : pilot study [ ISRCTN 61522618 ]

Background: Little research has directly evaluated the impact of increasing financial or material resources on health. One way of assessing this lies with assisting people to obtain full welfare benefit entitlements. In 2000–1, 2.3 million pensioners were living in poverty in the UK and estimates suggest that around one million do not claim the financial support to which they are entitled. The effectiveness of welfare rights advice services delivered via primary health care to promote health and reduce health inequalities is unknown. Methods: The main objectives of this study were to assess the feasibility and acceptability of a randomised controlled trial of welfare rights advice in a community setting and identify appropriate health and social outcome measures in order to plan a definitive trial. This was a single blind, community-based, pilot randomised controlled trial. 126 men and women aged 60 years and over, recruited from 4 general practices in Newcastle upon Tyne, UK, participated. The intervention comprised a structured welfare rights assessment followed by active assistance with welfare benefit claims over the following 24 months. The control group received the intervention after a six month delay. A range of socio-economic, health, behavioural and psycho-social outcomes were measured. Results: 126 out of 400 people invited agreed to participate and 109 were followed up at 24 months. Both the intervention and research procedures were feasible and acceptable to participants and professionals involved. 68 (58%) of all participants received a welfare benefit award (31 financial, 16 non-financial and 21 both). Median time to receipt of benefits from initial assessment was 14 (range 1 to 78) weeks and median financial award was £55 (€81, $98) per household per week. There was little evidence of health-related differences between groups or over time, which could be due to limitations of the study design. Conclusion: Modification of the study design, including selection of study participants, timing of interventions and length of follow up are recommended for a definitive trial. More appropriate health and psycho-social outcome measures relevant to the elderly population should be sought, particularly focussing on those issues highlighted in the accompanying qualitative study. Published: 21 June 2006 BMC Public Health 2006, 6:162 doi:10.1186/1471-2458-6-162 Received: 01 February 2006 Accepted: 21 June 2006 This article is available from: http://www.biomedcentral. com/1471-2458/6/162 © 2006 Mackintosh et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Page 1 of 10 (page number not for citation purposes) BMC Public Health 2006, 6:162 http://www.biomedcentral. com/1471-2458/6/162 Background Major inequalities in health result from differences in socio-economic position between individuals, families and population groups[1]. Whilst the link between resources and health is well established[1-4], there has been little conclusive research evaluating the impact of increasing resources on health[5]. In the UK large amounts of welfare benefits are unclaimed[6], particularly amongst vulnerable groups such as older people. It has been estimated that only around 40–60% of those eligible actually claim the health-related benefits to which they are entitled[7]. Appropriate targeting and active assistance with benefit claims can result in substantial increases in financial and non-financial resources (e.g. parking permits, household aids and adaptations) for eligible nonclaimants[8-10]. In the UK welfare rights advice is offered through local government social services departments, Citizens Advice Bureaux (one of the UK's largest voluntary organisations, providing free advice and information on money, legal or other problems) or primary care[11], with clients accessing the services either through self-referral, referral from another agency or both. However, these services are not available to everyone. Evaluating the health impact of complex social interventions poses ethical and methodological challenges. In particular, the ethical acceptability of withholding welfare advice or benefits from control group participants has been questioned[12]. Pilot studies play an important role in health research and are a necessary prerequisite for definitive randomised controlled trials[13,14]. Evaluations of the health effects of social interventions are essential to identify effective ways to reduce health inequalities[10,12]. We report the results of a pilot randomised controlled trial of welfare rights advice in a primary care setting, whilst Moffatt et al, in an accompanying paper[15], report the findings of an embedded qualitative study. We aimed to evaluate the methods, including a range of potential outcome measures, estimate effect sizes and sample size for a definitive trial. Methods Study design We conducted a single blind RCT with individuals randomly allocated to intervention (receipt of immediate welfare rights assessment, advice and active assistance with claims) or control condition (receipt of the intervention after a six month delay). Recruitment General practices Four practices working from five premises in Newcastle upon Tyne participated. Three premises were in the top ten per cent of the most deprived wards in England and two were in the top one per cent, measured using the Index of Multiple Deprivation[16]. Participants A random sample of 400 patients aged 60 years or over was generated using participating practices' computer systems, and invited to participate. Patients likely to have received full welfare assessments, such as the permanently hospitalised or those in residential or nursing care homes, were excluded. The sample size was pragmatic and aimed to enable us to estimate sample size for a future definitive trial. Intervention condition Within 3 weeks of the baseline assessment, a welfare rights officer from Newcastle City Council Social Services undertook a structured assessment of current welfare status and benefits entitlement, including a full assessment of household income and expenditure. Participants were then offered active assistance with making benefit and other welfare claims where appropriate over the following months. Advice was offered either at home or at the GP surgery, but all participants preferred a domiciliary service. Control condition Participants in the control group were given an appointment for a follow up interview with the researcher six months after their baseline assessment. Following this second interview, the control group were offered an appointment with the welfare rights officer, who offered a full welfare benefits assessment and active assistance with claims as appropriate, following the same procedure as the intervention group. Randomisation and blinding Following the baseline assessment, participants were randomly allocated to the intervention or control group by the project secretary using a sequential allocation table independently generated from random number tables prior to recruitment. The researcher conducting the assessments was blind to the randomisation group. Baseline assessment and outcome measures Written informed consent was obtained at baseline assessment. The following outcomes were collected in a structured, face-to-face interview at baseline, 6, 12 and 24 months: Health Short Form 36 (SF36)[17], Hospital Anxiety and Depression Scale (HADS)[18], activity limiting long term illness[19], symptoms inventory[20], the Pittsburgh Sleep Quality Index[21], and self-reported height and weight Page 2 of 10 (page number not for citation purposes) BMC Public Health 2006, 6:162 http://www.biomedcentral. com/1471-2458/6/162 (used to calculate Body Mass Index (weight in kg/height in m2)). Health related behaviours The Dietary Inventory for Nutrition Education (DINE),[22] the Physical Activity Scale for the Elderly (PASE)[23], current smoking status and weekly alcohol consumption[24]. Psycho-social factors Social Support Questionnaire[25], the Self-Esteem Inventory[26], the Personal Mastery Scale[27] and the Life Events Inventory[20]. Socio-economic status Affordability (financial vulnerability)[28] and Standard of Living Index[29]. In addition data were collected at baseline on age, sex, ethnicity and educational attainment. The salary, travel and administrative costs of providing welfare rights advice were estimated. Participants were contacted by telephone for repeat welfare assessments at 6, 12 and 24 (intervention) or 6 and 18 months (control) from the initial welfare assessment. When an application for benefits was made, the Welfare Rights Officer asked participants to notify her when a decision letter arrived, so that an accurate record could be kept of benefits received. Participants who had not notified her were followed up with telephone calls. Intervention cost per case was estimated by recording the number of minutes spent on each participant's case by the Welfare Rights Officer, including advice sessions, telephone calls and letter writing, and recording the number of miles travelled. Travel was costed at £0.404 (€0.595, $0.716) per mile, and staff time at £0.934 (€1.374, $1.656) per minute. Household income and major expenditure (housing costs, council tax, loan repayments and energy costs) were used to estimate household disposable income. Statistical methods Initial analyses were conducted on an 'intention-to-treat' basis, without regard to whether participants had received benefits as a result of the intervention. Explanatory analyses then compared outcomes in the intervention at different time points. The differences between mean changes from baseline in each outcome measure for the intervention an