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

Patton, D. E., Francis, J ORCID: 0000-0001-5784-8895, Clark, E., Smith, F., Cadogan, C. A., Ryan, C. and Hughes, C. M. (2019). A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: Study protocol. Pilot and Feasibility Studies, 5(1), doi: 10.1186/s40814-019-0506-6

Abstract

Background: Adhering 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. Methods: As 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. Discussion: Using 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 registration: This study is registered at ISRCTN: https://doi.org/10.1186/ISRCTN73831533

Publication Type: Article
Additional Information: © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
Publisher Keywords: Medication adherence, Polypharmacy, Theory, Behaviour change, Community pharmacists, Complexintervention, Pilot study, Process evaluation, Technology
Subjects: R Medicine
R Medicine > RC Internal medicine
Departments: School of Health Sciences > Healthcare Services Research & Management
URI: https://openaccess.city.ac.uk/id/eprint/23331
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