The proposed RCT with embedded economic and qualitative process evaluations aims to answer the following questions:
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1.
What are the effects on health-related quality of life of a domiciliary welfare rights advice service targeting independent-living, socio-economically disadvantaged older people (aged ≥60 yrs) identified via primary care?
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2.
What are the cost consequences and what is the cost-effectiveness of a domiciliary welfare rights advice service targeting independent-living older people (aged ≥60 yrs) identified via primary care?
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3.
What is the acceptability to trial participants and relevant professionals of a domiciliary welfare rights advice service targeting independent-living older people (aged ≥60 yrs) identified via primary care?
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4.
What are the unanticipated consequences (positive or negative) of a domiciliary welfare rights advice service targeting independent-living older people (aged ≥60 yrs) identified via primary care?
Study Design
The study is a pragmatic, individually randomised, single blinded, wait-list controlled trial of welfare rights advice versus usual care, with embedded economic and qualitative process evaluations. The qualitative study will examine whether the intervention is delivered as intended, explore responses to the intervention and examine reasons for the trial findings, and explore feasibility of the translation of the intervention into routine policy and practice. The trial design is illustrated in Figure 1, which has been drawn according to the CONSORT guidelines [34].
Primary outcome measure
The primary outcome is quality of life, measured using the CASP 19 questionnaire which was developed for use with older people [35, 36]. CASP stands for the four domains of Control, Autonomy, Self realization and Pleasure. CASP 19 will be administered by face-to-face interview at baseline (pre-randomisation) and at follow-up 24 months post-randomisation, and by postal questionnaire at 12 months post-randomisation.
Secondary outcome measures
The following secondary outcomes, based on the findings of previous research, including our own systematic review, qualitative study and pilot trial [7, 8, 20–22, 32, 37] will be collected:
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Health status, measured by the EuroQoL (EQ5D) [38]
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Functional ability measured by the modified Townsend activities of daily living scale [39]
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Independence categorised as: living independently or with carer support, in own home, with relations, care home or hospital (the latter two categories at follow-up only)
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Mental health measured by the PHQ-9 depression questionnaire [40–42]
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Health-related behaviours assessed by self-report to measure change in key indicator behaviours, such as smoking, alcohol consumption, diet (consumption of key food groups) and physical activity, as in our pilot RCT [7]
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Mortality assessed by identifying deaths at 12 months and 24 months from GP records (we will do this prior to commencing follow-up assessments, so as not to attempt to contact the recently deceased, which may cause distress to bereaved relations)
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Social support and participation measured by the Social Support Questionnaire [43].
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Perceived financial wellbeing measured by the Affordability Index [44].
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Fuel poverty measured where a household can achieve temperatures needed to maintain health and comfort for expenditure of less than 10 % of income [45]
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Financial status measured by a standard assessment tool developed and used in our pilot RCT [7]. This includes data on all sources of household income, including benefits, major outgoings (rent/mortgage, fuel bills etc.), debts and capital assets (i.e. home and savings). As well as these data, at follow-up detailed data will be collected (by WR Advisors) on new benefits received since baseline, including one-off (lump sum) payments and regular, weekly or monthly income.
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Material (dis)advantage measured through standard questions to ascertain home ownership, size of home (number of ‘living’ rooms), car ownership, and access to household amenities (such as central heating, cooker, fridge, freezer, etc.).
These outcomes will be assessed by structured, face-to-face interview at baseline (pre-randomisation) and 24 months post-randomisation.
Other quantitative data to be collected
As well as demographic factors including age, sex, ethnicity, marital status and living arrangements, including dependants, data will be collected to assess the costs of the intervention, from public sector and treasury perspectives (see ‘Health economic analyses’ below). The service costs of delivering the intervention will be assessed by collecting data on staff salaries from all participating services, as well as data on typical caseloads. WR Advisors routinely record information on visits to clients and we will use these data to estimate time spent with study clients, as well as travel costs. These data will be used to derive an average cost per case of delivering the intervention to our intervention group participants, as in our pilot RCT [7]. To assess the treasury perspective, total gains in financial benefits for all intervention clients will be provided by WR Advisors. We will also estimate the cost to the treasury of non-financial benefits based on details of successful claims provided by WR Advisors. These costs will then be summed to derive average costs to the treasury per case for all intervention participants.
Study population
Randomised controlled trial
Inclusion criteria – general practices
General practice populations in disadvantaged areas of North East England, including urban, rural and semi-rural areas, with no previous access to targeted welfare rights advice services delivered to primary care patients, will be included. All practices from participating social service districts will be ranked according to deprivation score (2010 English Index of Multiple Deprivation calculated at Middle Super Output Area level for practice postcodes, according to the method of Griffin et al [46].). Those practices in the lower two fifths of the deprivation ranking distribution without existing dedicated or targeted welfare rights advice services will be eligible for inclusion.
Inclusion criteria - patients
Exclusion criteria - patients
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Resident in social care (residential) or nursing homes or hospitals at the time of identification and recruitment
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Diagnosed with terminal illness
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Cannot participate in the research by virtue of current physical/mental health
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Lack of fluency in written and spoken English
Qualitative study
A range of professionals involved in service commissioning, policy and strategy will be interviewed including: (i) public health/NHS (GP commissioning consortia); (ii) social and welfare rights services; (iii) Pension Service, Department for Work and Pensions; and (iv) the voluntary sector. Trial participants will also be purposively selected to take part in interviews (see below).
Screening, recruitment, consent and randomisation
Identification and screening of trial participants
Practices will be recruited with the help of the Northern and Yorkshire Primary Care Research Network (PCRN-NY). The study will take place in 10 local authority districts (Stockton, Darlington, Middlesbrough, County Durham, Sunderland, South Tyneside, North Tyneside, Newcastle, Gateshead, Northumberland) which have agreed to provide welfare rights advice services. We plan to recruit two general practices per local authority district. Potentially eligible practices will be identified as described above. We will then liaise with Welfare Rights Services to establish whether any of these practices have existing dedicated or targeted welfare rights advice services, since this will render them ineligible. Next, we will ask the PCRN-NY to identify which of the practices still eligible have indicated willingness to participate in research. If more than two general practices from each list have expressed willingness to participate in research, we will order the remaining practices randomly and then contact them sequentially until two practices from each social services district have agreed to participate in the trial.
General practices in North East England have access (via PCRN-NY and the Comprehensive Local Research Networks (CLRNs)) to personnel and financial resources to identify and approach research study participants. Using PCRN-NY and CLRN personnel and financial resources, each participating practice will be asked to generate a random sample of up to 300 people aged ≥60 from their practice register. Practice staff will scrutinise their list to identify any patients terminally ill and patients known to be resident in hospital or long-term care, who will be excluded. They will also check to ensure that only one person per household has been selected for this list. If 2 or more people from the same address are found, one will be selected at random to be retained and the other(s) removed from the sample list.
Recruitment
This list of up to 300 names per practice will be randomly ordered and the first 100 patients on the list will be sent a letter and study information sheet by their GP, inviting participation in the trial. The letter will explain that, unless the participant objects (by returning an opt-out form to the practice within 2 weeks), their name and contact details will be passed to the research team, who will then contact them directly to discuss the trial further and seek informed consent. Patients’ views have been incorporated in the design of patient information sheets and consent forms and the opt-out approach has been approved by the Research Ethics Committee.
After two weeks, contact details of those who have not opted out will be passed to the research team. Research staff will contact these individuals and, if acceptable, arrange a face-to-face meeting at a mutually convenient time in the participant’s own home or another location of the participant’s choosing.
Our target for recruitment from each practice will be predetermined (depending on the final number of practices involved) in order to achieve the total sample. If this number is not achieved from the first 100 mailed, subsequent mailings of further names from the list of up to 300 will take place until the required number have been recruited. The number to be included in subsequent mailings will be determined by the number of responses already received (i.e. the yield rate of each wave of invitations). Since recruitment interviews will be spread over a six month period, this iterative recruitment process should not delay overall recruitment.
Consent
At the initial appointment, the research interviewer will first seek written, informed consent and then, if appropriate, proceed to collect baseline data. Interviewers will communicate in English, and if English is not the first language of any participant and (s)he is unable to speak it fluently, the participant will be excluded from the study. Friends, relations or carers will not be used as interpreters and interpreting services available to WR Advisors from local authorities will not be available for research interviews (the CASP19 has not been translated to other appropriate languages nor cross-culturally validated).
The researcher will assess if an individual has the capacity to consent. If it is established that an individual is unable to provide written consent because of literacy, vision or motor problems, it will be arranged for verbal consent to be taken in the presence of an independent witness (e.g. family member) who will initial, sign and date the consent form on the participant’s behalf.
Although unlikely to be a frequent occurrence, it is conceivable that a participant may lose mental capacity during the follow up period. We will explain to participants at baseline that, if this happens, we will retain the information that we gathered prior to his/her loss of capacity. The investigator and research interviewers will undertake all reasonable steps to protect the study participant. In accordance with the Mental Capacity Act 2005, nothing will be done to the person to which he or she appears to object (whether by showing signs of resistance or otherwise) except where what is being done is intended to protect him or her from harm or to reduce or prevent pain or discomfort.
Identification and recruitment of participants for qualitative sub-study
Interviews with approximately 30 purposively sampled trial participants will take place between 8–11 months and between 20–23 months from baseline (approximately 15 interviews in each period). Trial participants will be identified through the trial database and recruited to achieve a maximum variation sample with respect to group allocation, gender, age, benefit entitlements and any unanticipated consequences of the intervention identified at 12 month follow-up.
A sample of approximately 10 professionals/stakeholders will also be interviewed at 20–23 months from baseline. Stakeholders will include representatives of the Department for Work and Pensions, Benefits Agency, adult social services managers, welfare rights advisors, General Practitioners (GPs), primary care commissioners and directors of public health.
Trial participants will be asked during baseline assessment and consent procedures if they would be willing to participate in the qualitative interviews. Those selected for interview (trial participants and professionals/stakeholders) will be sent a letter of invitation and additional participant information sheet by the research team. Contact details for the researchers will be provided so that those approached to participate can ask any questions they may have before coming to a decision on participation. Separate informed consent will be taken for the interviews and lack of consent to participate in this element of the research will not prevent trial participants from continuing in the trial.
Sampling and interviews with both groups will continue until data saturation is achieved [47]. Interviews with trial participants will explore: acceptability of the intervention and research design; unanticipated consequences of the intervention; and perceived impacts of the intervention. Interviews with stakeholders will explore: acceptability of the intervention, training and research; fidelity of the intervention; and likely implications of the intervention for translation into routine policy and practice, both within the North East and more widely.
Sample size
Trial sample size and power
A minimum of 750 participants will be randomised to intervention and control arms, providing 90 % power at 5 % significance level to detect a 1.5 unit difference in mean CASP19 score [35, 36] between intervention and control groups, assuming a standard deviation of 8.7 and a correlation between baseline and 24 months of 0.74 [48], and 15 % attrition over 24 months (as experienced in our pilot RCT) [7]. There has been no published work to establish a meaningful or clinically important difference on the CASP19 scale. However, we have used data from two waves of the English Longitudinal Study of Ageing in those aged ≥60 yrs to investigate the adjusted mean difference in CASP19 at Wave 2 between groups whose social or health circumstances had changed [48].
Examples of changes in CASP19 score associated with changes in health or social circumstances that we might expect to see in the proposed trial include: ‘developed limiting illness’ -2.8 units; ‘developed depression’ -2.7units; ‘lost access to car’ -1.8 units; ‘increased chance will not meet financial needs’ -1.1 units. These differences on the CASP19 scale suggest that a difference of 1.5 units would represent a ‘clinically’ important difference.
The chosen sample size should also provide power to demonstrate some clinically significant differences in secondary outcomes. For example, 750 participants will provide 90 % power to detect a difference between a prevalence of 11 % and 4 % of clinically significant depressive symptoms (PHQ-9 score ≥10).
Qualitative sub-study sample size
Sample size for the qualitative sub-study will be determined by data saturation. We anticipate that up to 30 trial participants and up to 10 stakeholders will be included.
Study intervention details
Intervention
Welfare rights advice consultations and active assistance with benefit claims will be offered and delivered in participants’ own homes, tailored to individual needs by a trained WR Advisor employed by a local authority or Citizens’ Advice Bureaux (CAB) in North East England. Following randomisation, intervention group participants will be given an appointment in their own home with a WR Advisor within 2 weeks, during which participants will undergo a full benefit entitlement assessment involving: assessment of financial, material and welfare status; assessment of previous benefit entitlement and claims; discussion of current entitlement and options for action, including new claims (financial and non-financial). Active assistance with benefit claims and other welfare issues will be given. Complex claims or those referred for further assessment or tribunal will be managed in the usual way by WR Advisors. Participants will be followed up intermittently by WR Advisors until they no longer require assistance (cases are usually ‘closed’ once all claims and appeals have been resolved satisfactorily). It is expected that approximately 50 per cent of claims will be resolved within 3 months, but some may take up to 12 months [7]. The intervention will be funded and provided by WR Advice departments and CAB in 10 local authority areas across the North East by trained WR Advisors.
The North East Strategic Health Authority has provided funding for training of WR Advisors to ensure a consistent approach to delivery of the intervention. Such training was delivered in the context of our pilot RCT [7, 8] and Newcastle City Council, Welfare Rights Service has agreed to provide similar training for this trial.
Comparator (wait-list control condition)
Participants randomised to the control group will receive ‘usual care’ from both health and social services after randomisation until they have completed their 24-month follow-up assessment. They will be given no advice regarding welfare rights as a part of the study intervention during this period. However, they may independently seek welfare rights advice from the local authority, CAB or voluntary sector organisations. If this occurs, they will remain in the trial, but details of such advice and ensuing claims and outcomes will be recorded at the 24 months follow-up assessment. Following their 24-month follow-up assessment, they will receive the intervention, as delivered to the intervention group (described above), including all follow-up visits by WR Advisors and assistance with claims and appeals over the following months, until all claims have been resolved.
Long-term care
Both intervention and control group participants will remain clients of the welfare advice service beyond the end of the trial, if necessary, until such time as their help is no longer needed, as per usual welfare rights advice service protocols.
Randomisation
Following baseline measurements, participants will be randomised in a 1:1 ratio to intervention or control condition. Research interviewers will notify the project administrator after each baseline interview that a new participant has been successfully recruited. The administrator will hold sequential allocation tables for each practice, independently generated from random numbers prior to recruitment. The administrator will allocate all participants to intervention or control group in the sequence that they are recruited and immediately send each participant a standard letter informing them of their group allocation. The administrator will also immediately inform the appropriate WR Advisor of the contact details of each newly allocated intervention group participant and indicate that they are to be seen within 2 weeks. WR Advisors will be sent lists of control group participants to assess 24 months later. The research interviewers will not be notified of allocation status to ensure that they remain blinded for the duration of the study.
Study data
Data handling and record keeping
Study data will be entered directly into a secure database during interviews for processing and management, and a record of any changes made to the data post-entry will be maintained. All personal information obtained for the study will be held securely at Newcastle University and will be treated as strictly confidential. Entry and verification of twelve month data from self-completion questionnaires will be outsourced to a data entry company.
Data collection and transfer in this study will comply with UK NHS Research Ethics Service (NRES) http://www.nres.npsa.nhs.uk/ and Caldicott guidelines http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/Patientconfidentialityandcaldicottguardians/DH_4100563 and the Data Protection Act (1998) http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/Recordsmanagement/DH_4000489. All patients will be allocated a unique study identifier, which will be used on all data collection forms and questionnaires to preserve confidentiality; names or addresses will not appear on completed questionnaires or other data collection forms. Only a limited number of members of the research team will be able to link the unique identifier to patient-identifiable details (name, address and telephone number) which will be held on a password-protected database. All study documentation will be held in secure offices, not open to the public and all members of the research team with access to identifiable or anonymised data will operate to a signed code of confidentiality. Transmission of original or hard copy records (e.g. questionnaires, interview recordings) will be by secure fax, post or hand delivery by members of the research team or by the WR Advisors. Participants will be informed in the patient information sheet about the transfer of information to the research team and about levels of access to patient identifiable data, and will be asked to consent to this. Any data used in publications from the Do-Well study will be fully anonymised; it will not be possible to identify individual patients from such publications.
At the end of the study, original questionnaires, interview transcripts and consent forms will be securely archived for 15 years following publication of the last paper or report from the study, in line with Sponsor policy and Newcastle Clinical Trials Unit (NCTU) standard operating procedures. This will also allow any queries or concerns about the data, conduct or conclusions of the study to be resolved. Both sets of data will be archived after 5 years. Anonymised data will be submitted to a national archive collection.
Statistical analyses
Analyses of covariance and regression methods will compare primary and secondary outcomes between intervention and control groups at 24 months, adjusting for baseline outcome values and any imbalance in other covariates as appropriate.
Analyses will be by intention-to-treat. It will be necessary to consider any difference in attrition rates, and the non-randomness of the attrition, when comparing quality of life between the two groups. In the pilot RCT only 7/126 (5.5 %) died during the 24 month follow-up, so it is thought unlikely that methods for joint modelling of survival and longitudinal data will be necessary.
Exploratory sub-group analyses will also be undertaken, for example to examine differences in outcome between men and women, by age and by amount and type of benefits received.
Health economic analyses
The economic evaluation will consist of a cost analysis conducted from the perspectives of public sector services (‘Do-Well’ service delivery costs), and that of the Treasury (total cost of additional benefits paid out). The mean change in benefits and the mean change in total income of participants will also be calculated.
The cost analyses above will be used in conjunction with study outcomes to produce a cost consequences analysis [49]. If any significant change in EQ-5D health utility scores can be attributed to the intervention, we will undertake a cost-utility analysis [49]. The assumptions that underpin any such cost-utility analysis will be subjected to one-way sensitivity analysis [50] and, in addition, extensive probabilistic sensitivity analysis [50] will be used with results presented in the form of cost-effectiveness acceptability curves [50].
Qualitative analyses
All interviews will be digitally recorded (with permission) and transcribed verbatim. Data will analysed thematically following the Framework method [51] with constant comparison [52] and deviant case analysis [53] to enhance validity, supported by NVivo software [54].