This is an innovative trial designed to assess whether welfare rights advice delivered in their own homes to people from disadvantaged areas aged ≥60
years leads to improvement in health-related quality of life. The study is built on extensive prior research, which has led to consideration of a range of ethical and methodological issues. These are discussed in detail below.
Study design, level of randomisation, contamination and dilution
An appropriate trial design is required, preferably with both randomisation and concurrent controls. Individual level randomisation is preferable to cluster randomisation (e.g. at general practice level) as it requires a smaller sample size. The potential problem with individual level allocation is that there may be ‘contamination’ between intervention and control participants in the same general practice. Where welfare rights advice is available from an open access service delivered in the general practice this is more likely to be the case. However, by using a WR advisor who only sees patients in their own homes, we found in our pilot RCT that contamination did not occur; no control participants independently sought welfare rights advice during a follow-up period, albeit of only 6
Equipoise and the control condition
A key consideration in designing the proposed trial was whether there is genuine equipoise. Welfare rights advice is known to increase access to financial and material resources in eligible clients. However, our systematic review of published and grey literature indicated that there is, as yet, no conclusive evidence that welfare rights advice leads to positive or negative changes in health [21
]. We discussed these findings with welfare rights advisors, with directors of adult social services, with a selection of GPs and with members of the public in our target age group. We found each of these groups to be in equipoise with regard to the proposed trial health outcomes. Having established this, we also carefully considered the issue of study design and the ideal and feasible control conditions.
Ideally, controls should be adults as similar as possible to intervention group participants, but should not receive welfare rights advice, nor claim or receive new benefits, during the period of outcome follow-up. In clinical trials, it is usual to withhold the intervention from the control group because the health benefits of the intervention are not proven (i.e. clinical equipoise exists). Whilst this is the case with regard to the health impacts of welfare rights advice, as indicated above there is adequate evidence that welfare rights advice leads to significant financial and material gains for a proportion of recipients. Thus, it is considered ethically problematic to identify that control group participants are eligible to receive additional financial benefits, but either to keep this information from them, or to tell them of their eligibility but not give them advice or help with claims. To circumvent this dilemma, we proposed that control participants should not receive a welfare rights assessment until the end of the trial period (i.e. following final outcome measurement). The full intervention (i.e. a full benefit assessment and active assistance with claims until resolved) will then be offered.
There may be concerns about whether the welfare rights advisors might feel tempted to offer benefits advice to controls before the two year ‘wait period’ has elapsed. This will not be possible for the simple reason that the welfare right advisors will not know the names of controls until a few weeks before their benefits assessment is due (i.e. two years after the their baseline assessment). Control participants’ names will be held securely by the study team over this period.
The proposed design thus avoids unfairly raising expectations among controls. It also helps to avoid the potential problem of contamination, which could arise if control participants independently sought welfare advice (leading to dilution of the outcome effect), although we will not make any attempt to prevent this. The control condition is therefore, in effect, a ‘wait-list’ control, whereby the control group will wait to receive the intervention 24
months after the intervention group.
It is, of course, possible that some members of both intervention and control groups may die during the proposed 24
months follow-up period, and we would expect this in the course of any prospective study of this age group. In our pilot study, we recorded 7 deaths (4 intervention group, 3 control group) after 24
months follow-up [7
The proposed design of this RCT is fair because, at present, this kind of intervention is not routinely available to primary care patients and is generally only available to those who seek such services or are referred to them by a health or social care professional (e.g. a hospital social worker); these options remain open to patients in this trial. When targeted services are available in primary care, they tend to be short term and ad hoc
. If we find any general practices in participating districts with access to such services they will be excluded from this trial. Genuine equipoise exists for the proposed health-related outcomes because participants will not be denied any entitlement that they would otherwise have received and, at present, the health impact of the proposed intervention is unknown [21
Pragmatic versus explanatory
Not all participants in the intervention group will be eligible for additional benefits, and for those who are, they may receive variable amounts of financial and non-financial benefits. Ideally, we would wish to examine the health impact of receiving versus not receiving such benefits, as well as examining the potential for a gradient of effect (‘dose-response’ relationship) by amount of benefit received. However, to do so would require a substantially larger sample size. In practice, therefore, the receipt of welfare rights advice is the intervention we are evaluating (rather than receipt of specific benefits), since ‘welfare rights advice’ is the service being delivered. The proposed trial is therefore a pragmatic (intention-to-treat) RCT of this complex intervention. Nevertheless, we will also assess the potential for exploratory sub-group analyses looking at differential effects by participant characteristics (such as age and sex), receipt/non-receipt of, and levels of any benefits received. We anticipate that the trial will therefore contribute both to answering the question of whether the complex welfare rights advice intervention is effective in improving health and to providing new evidence on the theoretical question of whether increasing resources leads to better health [9
Length of follow-up
To enable accurate assessment of the health and social effects of welfare rights advice, an appropriate length of follow up is required. Experience from previous work suggests that considerable time may elapse between first advice session and receipt of new financial or material benefits. Often this is between 3 and 6
months, but can be longer if the case is not straightforward or if there is an appeal. For example, in our pilot RCT, 45
% had received their entitlements by 3
months after their welfare assessment, 85
% after 6
% after 9
months and 100
% by 12
]. Given such delays in receipt of benefits, as well as the fact that once received they need to be spent, it seems unlikely that they will have substantial impacts on health within the first 12
months. In our pilot, which was not adequately powered for substantive analyses, we found no suggestion of differences in health-related outcomes between intervention and control groups after 6, 12 or 24
months (although controls received the intervention after 6
]. Nevertheless, it seems likely that the longer the delay between receipt of intervention and measurement of outcomes, the greater the chance of demonstrating a substantive effect on health.
To assess the acceptability of a range of delays in receiving the intervention among control group participants, we undertook an experiment in the context of a focus group discussion with a representative sample of low income, older people. To achieve this, simulations of the RCT randomisation procedures were undertaken. The first simulation concerned a typical drug trial and participants were given different coloured sweets depending on whether they were in the intervention or control groups. Then, randomisation for the proposed trial was simulated. The concept of equipoise, with regard to the health impacts of welfare rights advice was explained. Next, each group member was given an envelope from which they found out whether they were in the control group or the intervention group. If in the intervention group, they were allocated various types of benefit (e.g. Attendance Allowance
Council Tax Benefit
Housing Benefit) and the monetary value of these was revealed to them. We then talked through various time delays until the control group would also receive their welfare rights assessment and advice. The time delays used were 3
months and 60
months. The initial response to the design was that it was unfair on the control group. However, when it was explained that: (i) while such services exist, they are not routinely targeted at or delivered to all people aged over 60, but only available on referral or demand; (ii) the findings of this study could influence the development of such services, involving collaboration between health and social services; and (iii) that a substantial ‘wait’ between intervention and control groups is needed to establish any differences in health outcome, the consensus of the group was that a delay of 24
months would be acceptable in the context of the proposed trial. We have, therefore, opted for a wait-list design for the proposed RCT, with a 24
month follow-up period for the main outcome assessment, followed immediately by delivery of the full intervention to the control group.
In our pilot RCT, GPs wrote to random samples of people aged over 60
years, inviting them to respond with an indication of their willingness to participate in the trial, i.e. to ‘opt in’ [7
]. Using this method, 36
% initially agreed to participate, 14
% declined to participate and 50
% failed to respond. Low levels of positive response to an ‘opt in’ approach carry risks of participation bias [55
]. In their work on evaluating the impact of welfare rights advice for the Department of Work and Pensions [36
], Sainsbury and colleagues routinely use an ‘opt out’ method of recruitment for similar populations [57
]. With the agreement of NRES we are using this type of recruitment method in this trial. This should significantly reduce the potential recruitment bias associated with ‘opt in’ recruitment methods and significantly increase the efficiency of trial recruitment.
Choice of outcome measures
Previously reported studies of the health effects of welfare rights advice have restricted reported health outcomes to general measures of health or psycho-social functioning (such as the SF36 [29
]) together with measurement of financial gains. In our earlier qualitative research among recipients of welfare rights advice, we identified a range of potential benefits of advice: [22
Health (improvements in anxiety, depression, insomnia, reductions in medication or consultation, and health promoting changes in smoking, diet, physical activity, alcohol consumption)
Social (improvements in family or other relationships, increased ability to work, ability to care for relatives, etc.)
Financial (debt rescheduling and receipt of new benefits, e.g. Attendance Allowance, Disability Living Allowance, Mobility Allowance, Invalid Care Allowance, Incapacity Benefit, Housing Benefit, Income Support)
Material (e.g. access to free prescriptions, council tax exemption, entitlement to respite care, meals on wheels, re-housing or home modifications etc.)
The qualitative findings identified perceived benefits of the intervention in terms of:
increased affordability of necessities
increased capacity to manage unexpected future problems
decrease in stress related to financial worries
increased independence, including ability to travel, shop, visit GP etc.
increased ability to participate in family life and society
We undertook further qualitative work with study participants in our pilot RCT as well as collected planned outcome measures [8
]. The pilot trial was not sufficiently powered for substantive analyses, but the feasibility of measurements was good, and well tolerated by older people.
These findings, together with those from recent, similar research [37
] point to the most significant health-related impacts of welfare rights advice being on quality of life, independence, social participation and mental health. There is no single, ideal outcome measure that captures all of these domains, but the CASP19 instrument [35
], developed specifically with a view to measuring quality of life in older people, comes close and has been recommended by Corden et al as a composite measure of the impact of welfare rights advice [36
]. It is a self-reported summative index, comprising 19 Likert scale items in 4 domains: control, autonomy, self-realisation and pleasure [35
]. Its performance has been examined in several prospective studies, including the English Longitudinal Study of Ageing (ELSA) [48
Our pilot trial was undertaken in one social services district (Newcastle upon Tyne) and in 4 general practice populations [7
]. However, we know, from other work and discussions locally, that service delivery in welfare rights advice varies from area to area, as do general practice populations. To enhance the potential generalisability of the results, the RCT will therefore be undertaken across a range of geographical and local authority areas (including urban and rural) and general practices. It is possible, indeed likely, that the present welfare regime will change during the course of the trial. The proposed intervention is not dependent on any particular set of benefits and is adaptable to any new regime. This adds to its future generalisability.
Although we recognise that isolated older people who are eligible for benefits may live in all areas, in order to maximise the efficiency (and impact) of welfare rights advice services provided through primary health care, this RCT focuses on practice populations in socio-economically disadvantaged areas. Eligibility for health-related benefits (and failure to claim) increases with age, particularly post-retirement, although there are other key target groups such as single parents, non-claimants most likely to be accessed through primary care are predominantly in older age groups [15
]. This trial therefore focuses on a predominantly post-retirement population (aged ≥60
years), residing in areas of economic deprivation.
Nature of the intervention
The intervention to be delivered in the proposed trial is based on standard WR Advice services, of the type that can be found across local authorities in England. Conventionally, however, these services are available only on demand or by referral. Thus, for example, an older person admitted to hospital may be referred by a hospital social worker, doctor or nurse for benefits assessment prior to discharge. Only some services have undertaken targeting of WR Advice at a population level [21
]. Those that have done so have found that there is a significant level of under-claiming in the general population and in particular among older people [18
]. The proposed intervention is therefore a modification of a standard WR Advice service to target proactively a particularly vulnerable population in which we know there are high levels of under-claiming (i.e. over 60s in disadvantaged areas). The only reliable population registers in England at a local level are the primary care patient registration lists held by GPs and PCTs, which will be used to sample this target group selectively.
In our pilot RCT, we identified that efficiency and effectiveness (in terms of successful claims) could be maximised by making the service domiciliary, since a substantial proportion of over-60s have limited mobility and clients often need access during assessments to information kept at home [22
]. Domiciliary visits also proved more popular with clients. We also found that welfare rights advisors need to provide ‘active assistance’ with claims, for example completing claim forms for clients, since this is a key barrier to claiming [8
]. Lastly, GPs need to have appropriate awareness of welfare entitlements and, for health-related benefits in particular, an understanding of the medical criteria on which decisions are made so as to be able to support reasonable claims effectively in medical assessments requested by the benefits agency. Good communication between GPs and welfare rights advisors is essential to facilitate this. In our pilot RCT, we delivered education and training on these issues to all GPs in participating practices [7
], another feature that is included in the proposed definitive RCT.