The Identification of Medication Adherence Barriers Questionnaire intervention (IMAB-Qi): Developing a package to support IMAB-Qi delivery in general practice and a trial to test IMAB-Qi effectiveness and cost-effectiveness

Background Half of patients do not adhere to prescribed medication directions.

Patients and Health Care Professionals (HCPs) struggle to identify a patient s main barriers to adherence and therefore fail to select tailored interventions. We have developed and validated the 10-item Identification of Medication Adherence Barriers Questionnaire (IMAB-Q). The IMAB-Q diagnoses a patient s main barriers to adherence.

Each IMAB-Q barrier is linked to theory and evidence-based adherence interventions from which HCPs and patients can select.

The IMAB-Q to identify barriers to adherence combined with interventions to address them forms the IMAB-Q intervention (IMAB-Qi). Medication reviews (MRs) in general practices require HCPs to identify and address non-adherence. Implementing IMAB-Qi into MRs fulfils this requirement.

Our underpinning PDG determined that general practice teams require an implementation package to deliver the IMAB-Qi within existing MRs.

Aims To develop an implementation package to deliver the IMAB-Qi in MRs and test IMAB-Qi s safety, effectiveness and cost-effectiveness.

Methods The IMAB-Qi is intended for patients with any diagnoses and prescribed medicines; work packages (WP) 1 and 2 will develop an implementation package to deliver the IMAB-Qi within all MRs.

Our PDG co-design workshops determined that WPs 3, 4 and 5 will test the IMAB-Qi delivered in a subset of MRs for patients prescribed at least one antihypertensive medicine.

This fulfils PGfAR requirements for a clinically relevant primary outcome (blood pressure at 12 months) whilst still testing IMAB-Qi in a population prescribed a diverse range of medicines to treat co-morbidities.

WP1(6 months): Using scenarios designed by patients, we will user test the IMAB-Qi with HCPs (n=20) in MR simulations in general practices followed by focus groups to understand their experience and diagnose the determinants of IMAB-Qi delivery.

WP2(11 months): We will co-design an IMAB-Qi implementation package to address determinants of delivery within MRs and an associated fidelity framework with panels of patients (n=12) and primary care staff (n=8-12) involved in IMAB-Qi implementation and delivery.

WP3(17 months): Three intervention general practices will test the feasibility of trial procedures and IMAB-Qi implementation package, one control practice will test trial procedures. Trial and process evaluation data will determine whether a definitive trial is feasible. WP4(36 months): We will 1:1 randomise 38 general practices to intervention or control.

Practices will have two months to deploy the implementation package followed by two months of IMAB-Qi delivery (n=1,520).

This will provide 90% power at 5% significance for detecting a mean 5 mmHg difference in systolic blood pressure between intervention and control at 12-months.

WP5(53 months): Alongside WPs 3/4, we will undertake an economic evaluation, constructing a long-run hypertension-focussed health economic model to estimate the costs and benefits associated with IMAB-Qi s effects over participants lifetimes.

Impact and dissemination Underpinned by an evidence-based framework for dissemination, we will work with the PPI and primary care influencer groups established in our PDG to identify dissemination audiences, design activities to share messages and strategies to monitor impact. Passive dissemination activities will include a website, newsletters and social media.

Active dissemination activities will include workshops, webinars and discussion fora.