The Impact Study: A Cluster-randomised Clinical and Health Economic Feasibility Study of a Theory-based Manualised Intervention to Support People With Tuberculosis Disease During Treatment

<h3>Introduction and Objectives</h3> Treatment for tuberculosis (TB) with multiple, potentially toxic, drugs lasts months but will cure &gt;90% with drug sensitive TB, if taken as prescribed. Non-adherence inevitably occurs, and most methods to improve adherence use medication ‘reminders’ or supervised treatment that may not take into account the broader psychosocial and structural issues affecting adherence. We developed a theory-based manualised intervention including an enhanced structured needs assessment and risk management plan, educational videos, and an interactive patient booklet, to support adherence during anti-TB treatment. We report the intervention’s acceptability to patients and its ability to influence perceptions and behaviour when compared to standard care. <h3>Methods</h3> Adult TB patients were recruited from four London TB centres within a pilot cluster-randomised controlled trial. Assessments included a process evaluation (to determine acceptability), the Beliefs about Medicines Questionnaire (BMQ) administered at 2 weeks, 3 and 6 months from baseline (measuring patient perception), and treatment monitoring boxes recording medication use (reflecting patient behaviour, measured as the proportion of doses taken at 168 days from treatment start). <h3>Results</h3> 80 patients were recruited to the study (37 intervention, 43 control). Ethnicity and gender were evenly split between arms, age ranged from 18–81 years, with the largest group 28–38 years. The intervention had a positive effect on perceptions of treatment necessity compared to controls from 2 weeks to 3 months (<i>p</i>=.05) (medium to large effect size). Patients regarded all elements of the intervention as helpful, with mean helpfulness ratings (min0-max100) of 86 (patient booklet), 82 (needs assessment), 77 (medication diary/plan) and 72 (videos). The unadjusted mean proportion of doses taken over 168 days in the control arm was 0.88 compared to 0.81 in the intervention arm (estimated mean difference of -0.07, p= 0.23, CI -0.41–0.27). Adjusted estimates were similar. <h3>Conclusions</h3> The IMPACT intervention is acceptable to patients and may change their perceptions of anti-TB treatment, though this was not reflected in increased total adherence. Measures to sustain the intervention’s effect throughout treatment should be investigated in future work. Please refer to page A211 for declarations of interest related to this abstract. 

S80 A cluster-randomised evaluation of a theory-based intervention to help people with TB disease get the most from their treatment and care: the IMPACT feasibility study

<h3>Introduction and Objectives</h3> Compared to the rest of the UK and Western Europe, England has high rates of tuberculosis (TB). Non-adherence to TB treatment can be detrimental for patients’ health and lead to onward infection. The IMPACT study developed a complex manualised intervention including an enhanced TB needs assessment (TNA) for use in routine care within the National Health Service (NHS) to address the demographic, medical, practical, structural, and psychosocial factors contributing to poor adherence. For the health economics workstream of this feasibility study, we aimed to assess the feasibility of capturing useable health economic data in this context, with a view to planning a cost-effectiveness analysis in a future full trial. <h3>Methods</h3> Client Service Receipt Inventory (CSRI) and EQ-5D-5L questionnaires were administered at baseline and two, four, and six months post-baseline to 79 adult study participants from four sites in London to collect information on healthcare resource use and health-related quality of life (HRQoL), respectively. Use of TB-related medications was captured from records at baseline and every follow-up timepoint (two weeks, then monthly from one to six months). Time spent delivering the intervention or standard of care was also captured in the respective arm. Descriptive statistics including levels of missingness were produced for the whole group and by intervention arm. No formal statistical testing was performed due to the small sample size, in accordance with the analysis plan. <h3>Results</h3> Completion rates of CSRI and EQ-5D-5L questionnaires ranged between 71–99% across timepoints, with differing degrees of missingness and data queries required according to the type of information captured. Utility scores could be calculated from EQ-5D-5L responses for HRQoL, and costs could be calculated for the different categories of healthcare resources used by applying unit cost information to the captured resource use information, with input from clinical and other colleagues on the study team. <h3>Conclusions</h3> Our preliminary results suggest that collecting patient-reported and record-based resource use and HRQoL data is feasible in this patient group. Further refinement of the database design would be required to make the collection and analysis of resource use data less labour intensive for the future study. Please refer to page A215 for declarations of interest related to this abstract. 

P151 Intervening with a Manualised Package to AChieve treatment adherence in people with Tuberculosis (IMPACT): feasibility of collecting cost and quality of life data from records and patients

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The Impact Study: A Cluster-randomised Clinical and Health Economic Feasibility Study of a Theory-based Manualised Intervention to Support People With Tuberculosis Disease During Treatment

S80 A cluster-randomised evaluation of a theory-based intervention to help people with TB disease get the most from their treatment and care: the IMPACT feasibility study

P151 Intervening with a Manualised Package to AChieve treatment adherence in people with Tuberculosis (IMPACT): feasibility of collecting cost and quality of life data from records and patients