Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study.

Janet K Sluggett,Esa Y H Chen,Tessa Caporale,Michelle E Hogan,J Simon Bell,Georgina A Hughes,Megan Corlis,Jan Van Emden,Choon Ean Ooi

doi:10.3390/ijerph18115778

Abstract

Complex medication regimens are highly prevalent, burdensome for residents and staff, and associated with poor health outcomes in residential aged care facilities (RACFs). The SIMPLER study was a non-blinded, matched-pair, cluster randomized controlled trial in eight Australian RACFs that investigated the one-off application of a structured 5-step implicit process to simplify medication regimens. The aim of this study was to explore the processes underpinning study implementation and uptake of the medication simplification intervention. A mixed methods process evaluation with an explanatory design was undertaken in parallel with the main outcome evaluation of the SIMPLER study and was guided by an established 8-domain framework. The qualitative component included a document analysis and semi-structured interviews with 25 stakeholders (residents, family, research nurses, pharmacists, RACF staff, and a general medical practitioner). Interviews were transcribed verbatim and reflexively thematically content analyzed. Descriptive statistics were used to summarize quantitative data extracted from key research documents. The SIMPLER recruitment rates at the eight RACFs ranged from 18.9% to 48.6% of eligible residents (38.4% overall). Participation decisions were influenced by altruism, opinions of trusted persons, willingness to change a medication regimen, and third-party hesitation regarding potential resident distress. Intervention delivery was generally consistent with the study protocol. Stakeholders perceived regimen simplification was beneficial and low risk if the simplification recommendations were individualized. Implementation of the simplification recommendations varied between the four intervention RACFs, with simplification implemented at 4-month follow-up for between 25% and 86% of residents for whom simplification was possible. Good working relationships between stakeholders and new remunerated models of medication management were perceived facilitators to wider implementation. In conclusion, the one-off implicit medication simplification intervention was feasible and generally delivered according to the protocol to a representative sample of residents. Despite variable implementation, recommendations to simplify complex regimens were valued by stakeholders, who also supported wider implementation of medication simplification in RACFs.

Highlights

Medication regimen complexity is prevalent in residential aged care facilities (RACFs)
Residents at four RACFs were randomized to receive usual care, while those in four matched RACFs received a medication simplification intervention delivered by an experienced clinical pharmacist using the 5-item Medication
Qualitative evaluation showed RACF participation was facilitated by senior staff appreciation for the importance of the study objective, opportunities to improve workflow, research team flexibility with respect to recruitment commencement, and the interdisciplinary nature of the project

Summary

Introduction

Medication regimen complexity is prevalent in residential aged care facilities (RACFs).Simplifying medication regimens for residents could lead to benefits such as improved resident wellbeing, more staff time for other care activities, safer medication administration practices and greater resident involvement in medication-related decision making [1,2,3].Trialing medication simplification activities in RACFs is important due to associations between complex medication regimens and medication administration errors, unplanned hospitalizations and mortality in older people [4,5].The SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER)study was a non-blinded, matched-pair, cluster randomized controlled trial (RCT) of a single multidisciplinary intervention targeting complex medication regimens [1,3,6,7,8].SIMPLER was the first prospective study to investigate the benefits and harms of medication regimen simplification in RACFs. Trialing medication simplification activities in RACFs is important due to associations between complex medication regimens and medication administration errors, unplanned hospitalizations and mortality in older people [4,5]. The SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER). Study was a non-blinded, matched-pair, cluster randomized controlled trial (RCT) of a single multidisciplinary intervention targeting complex medication regimens [1,3,6,7,8]. SIMPLER was the first prospective study to investigate the benefits and harms of medication regimen simplification in RACFs. Medication simplification involves consolidating administration times (e.g., by administering medications at the same time, switching to combination products or long-acting formulations) without changing the therapeutic intent of the medication regimen [1,3,9]. Residents at four RACFs were randomized to receive usual care, while those in four matched RACFs received a medication simplification intervention delivered by an experienced clinical pharmacist using the 5-item Medication

Objectives

Methods

Results

Discussion

Conclusion