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

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 investigat...

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Autores principales: Sluggett, Janet K., Hughes, Georgina A., Ooi, Choon Ean, Chen, Esa Y. H., Corlis, Megan, Hogan, Michelle E., Caporale, Tessa, Van Emden, Jan, Bell, J. Simon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8199013/
https://www.ncbi.nlm.nih.gov/pubmed/34072223
http://dx.doi.org/10.3390/ijerph18115778
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author Sluggett, Janet K.
Hughes, Georgina A.
Ooi, Choon Ean
Chen, Esa Y. H.
Corlis, Megan
Hogan, Michelle E.
Caporale, Tessa
Van Emden, Jan
Bell, J. Simon
author_facet Sluggett, Janet K.
Hughes, Georgina A.
Ooi, Choon Ean
Chen, Esa Y. H.
Corlis, Megan
Hogan, Michelle E.
Caporale, Tessa
Van Emden, Jan
Bell, J. Simon
author_sort Sluggett, Janet K.
collection PubMed
description 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.
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spelling pubmed-81990132021-06-14 Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study Sluggett, Janet K. Hughes, Georgina A. Ooi, Choon Ean Chen, Esa Y. H. Corlis, Megan Hogan, Michelle E. Caporale, Tessa Van Emden, Jan Bell, J. Simon Int J Environ Res Public Health Article 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. MDPI 2021-05-27 /pmc/articles/PMC8199013/ /pubmed/34072223 http://dx.doi.org/10.3390/ijerph18115778 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sluggett, Janet K.
Hughes, Georgina A.
Ooi, Choon Ean
Chen, Esa Y. H.
Corlis, Megan
Hogan, Michelle E.
Caporale, Tessa
Van Emden, Jan
Bell, J. Simon
Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title_full Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title_fullStr Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title_full_unstemmed Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title_short Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study
title_sort process evaluation of the simplification of medications prescribed to long-term care residents (simpler) cluster randomized controlled trial: a mixed methods study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8199013/
https://www.ncbi.nlm.nih.gov/pubmed/34072223
http://dx.doi.org/10.3390/ijerph18115778
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