Title: Randomised controlled trial economic and process evaluation of domiciliary welfare rights advice for socio-economically disadvantaged older people recruited via primary health care (DO-WELL Trial)
Funder: Department of Health (England)

Abstract: Design: An individual randomised single blind wait-list controlled trial with economic and qualitative process evaluations.Setting: GP 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.Target population: Volunteer men and women 60 years and over (1/household) identified from GP patient registers. Patients in nursing homes or hospitals will be excluded.Intervention being evaluated: Welfare advice consultations and active assistance with benefit claims delivered in participants’ own homes by a trained welfare rights advisor (WRA).Control condition: ‘Usual care’ including voluntary access to available welfare rights services until 24m follow up when the trial intervention will be offered.Measurement of outcomes and duration of follow up:Primary outcome: quality of life (CASP 19)Secondary outcomes: health status (Euroqol EQ5D) functional ability (ADLs/IADLs) independence (living independently with carer support in own home or a relations care home or hospital) social support/participation (Social Support Questionnaire) depression (PHQ-9) mortality key health related behaviours (diet physical activity alcohol smoking) perceived financial well-being (Affordability Index) fuel poverty (achievement of household temperature sufficient to maintain health for expenditure of <10% of household income).Outcomes will be assessed by structured face-to-face interview at baseline and 24 months and by self-completion questionnaire (CASP19 only) at 12 months. We will cost the intervention and welfare outcomes using methods developed in our pilot RCT.Sample size: A minimum of 750 participants will be randomised to intervention and control arms (375 to each arm) providing 90% power at 5% significance level to detect a 1.5 unit difference in mean CASP19 score between intervention and control groups assuming 15% attrition between baseline and 24 months (as experienced in our pilot RCT).A qualitative process evaluation study will examine whether the intervention is delivered as intended explore responses to the intervention examine reasons for the trial findings and assess generalisability of the intervention. Semi-structured interviews will be undertaken with up to 30 purposively sampled participants in two phases and with up to 10 stakeholders. Interviews will be digitally recorded (with permission) and transcribed verbatim.Planned analyses: Intention-to-treat analyses will compare primary and secondary outcomes between interventions and controls at 24 months adjusting for baseline values. Exploratory analyses will also be undertaken.Economic analyses will be conducted from the perspectives of the public sector (service delivery costs) and the Treasury (total cost of additional benefits paid out). A cost consequences analysis in relation to outcomes will be conducted and the potential for a cost-effectiveness analysis using EQ-5D will be explored.Qualitative data will be analysed using the Framework method. Qualitative findings will aid interpretation of trial outcomes.Project timetable: months -6 to 0: set up (recruitment of staff completion of ethics/governance requirements); months 0-3: finalise materials recruitment & training of GPs and WRAs; months 4-9: recruitment; months 16-33: follow-up; months 34-39: analyses; months 37-42: preparation of publications policy briefing stakeholder event conference dissemination public engagement and contingency.Recruitment rate will be 30 participants/week over 25 weeks across 10 general practices in 5 local authority areas served by 5 WRAs and 4 research interviewers.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: GENERIC HEALTH RELEVANCE