Title: Exploring habit formation in medication adherence for an archetypal long-term condition: time series analyses of objective nebuliser data in people with Cystic Fibrosis
Funder: Department of Health and Social Care

Abstract: Background Poor adherence is a significant barrier to managing long-term conditions. The NHS spends 13-14 billion annually on medicines, yet 30-50% of these are not taken as recommended.[10] Effective adherence interventions may have a greater impact on population health than improvement in specific medical treatments.[10] CF is an archetypal long-term condition. Good nebuliser adherence in CF is associated with better health and lower treatment costs,[11] but median adherence is only 36%.[2] Improving nebuliser adherence will improve health by reducing the gap between what people with CF (PWCF) need and what they receive. Habitual behaviours tend to remain stable with unchanging context. Statistical process control (SPC) is a visual statistical method that can be used to identify the stability and timing of behavioural patterns. This research proposes using SPC to study nebuliser adherence and 'habit' the psychological concept of 'habit' to understand and change nebuliser adherence among PWCF. Aims Determine the role of SPC as an investigative tool to understand adherence patterns Explore the role of SPC in tracking habit objectively Explore the role of habit in supporting adherence Develop and test the feasibility of a personalised habit-forming nebuliser adherence intervention Questions to be addressed1A How best to identify a change in adherence? 1B How to measure habit objectively? 2 What sustains nebuliser adherence? 3 How durable is habit? 4 How to personalise a habit-forming intervention with objective adherence data? Investigation plan A series of 4 work packages is planned: Work package 1: (month 1-4) Retrospective analysis of objective adherence data using SPC to: Determine the optimal way of identifying a change in adherence and habit Generate a novel 'objective' habit score and validate it against established habit indicators Work package 2: (month 1-10) Mixed methods cross-sectional study of PWCF with stable adherence of 80% over a year to understand: Predictors (including habit strength) of behaviours among this group Processes surrounding nebuliser use and the automaticity of these processes Questionnaires and semi-structured interview with script elicitation will be used among 20 PWCF. Work package 3: (month 1-31) Mixed methods prospective observational study of newly transitioned PWCF to understand how context, habit, behaviour (adherence) and other predictors of behaviours (e.g. motivation, opportunity) change over 12 months during this turbulent period. This will involve questionnaires and semi-structured interviews with adapted script elicitation during every routine clinic review for 15 PWCF. Work package 4: (month 6-28) A proof of concept study to develop and test the feasibility of delivering a personalised habit-forming behaviour change intervention to support nebuliser adherence, guided by adherence data analysed with SPC. This is a prospective single-arm un-blinded study with 25 PWCF delivered in 2 phases: Phase I: personalised habit-forming advice and self-monitoring, then review at 3 months Phase II: regular contact with investigator and intervention adjusted based on adherence response for 6 months This work package aims to: understand the process of habit formation for using nebuliser develop and test the feasibility of a personalised habit-forming nebuliser adherence intervention Summary of potential benefits PWCF: Improving adherence can improve the health of PWCF but no effective adherence intervention exists.[11] Habit formation can provide a mechanism to sustain long-term adherence.[12] NHS: Poor adherence increases unscheduled care (including hospital admission), so poses considerable costs to the NHS.[13] As more expensive new treatment options are introduced,[14] optimising medication use is vital to obtain value-for-money. The NHS will benefit from this work by the cost savings arising from optimising medication use. General benefit for other patients with long-term conditions: 30-50% of all prescribed medications are not taken.[10,15] Knowledge generated by this research can aid the development of adherence-promotion interventions in other long-term conditions.

Lay abstract: Daily nebulised treatment is crucial for people with cystic fibrosis to stay healthy, but average adherence is only 36%. Making nebuliser use 'habitual' (i.e. automatic) may aid adherence, but more work is needed to examine the role of 'habit' in adherence. Statistical analysis and visual display of electronically-captured nebuliser usage data can potentially identify and monitor habitual adherence.CHAR(13) + CHAR(10)CHAR(13) + CHAR(10)This research uses innovative statistical methods to study nebuliser use behaviour and habit, and to inform the development of a novel evidence-based strategy to support nebuliser adherence. Four projects, using both qualitative (i.e. interviews) and quantitative (i.e. statistical) methods, are proposed.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CONGENITAL DISORDERS