A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

D E Patton,E Clark,F Smith,C A Cadogan,C M Hughes,J J Francis,C Ryan

doi:10.1186/s40814-019-0506-6

Abstract

BackgroundAdhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change.MethodsAs part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive.DiscussionUsing pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures.Trial registrationThis study is registered at ISRCTN: https://doi.org/10.1186/ISRCTN73831533

Highlights

Adhering to multiple medications as prescribed is challenging for older patients and a difficult behaviour to improve
Process evaluation and progression criteria A process evaluation will be embedded in the study to assess: (1) training fidelity and acceptability, (2) intervention fidelity and acceptability from the viewpoint of patients and pharmacists and (3) the mechanism of action of the intervention. It will explore if the training is delivered by the researchers and received by the pharmacists as intended and evaluate how acceptable this is to pharmacists
The findings of this study will be communicated to all participants, published in relevant journals and presented at conferences. The aim of this pilot study is to test the feasibility of the Solutions for Medications Adherence Problems (S-MAP) intervention and study procedures in community pharmacies in Northern Ireland (NI) and London

Summary

Introduction

Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Polypharmacy, often defined as the use of multiple medicines [1], is increasingly accepted as the new paradigm for prescribing in older adults (≥ 65 years) [2] This can give rise to challenges with adherence, a behaviour that is influenced by multiple factors, and has proved resistant to interventions [3]. The UK Medical Research Council (MRC) recommends that complex interventions are designed, evaluated and reported in a systematic and rigorous way [6]

Objectives

Methods

Conclusion