Bond, CM, Holland, R, Alldred, DP orcid.org/0000-0002-2525-4854 et al. (17 more authors) (2020) Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study. Trials, 21 (1). 439. 439-. ISSN 1745-6215
Abstract
Background
Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
Aims and Objectives
To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation.
Objectives
1. 1.
To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time.
2. 2.
To explore the effects of individual intervention components on the primary outcomes.
3. 3.
To investigate the mechanisms of impact.
4. 4.
To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives.
5. 5.
To describe the characteristics of GP, care home, PIP and resident participants to assess reach.
6. 6.
To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff.
Methods
A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service.
Discussion
Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data. |
Keywords: | Older people, pharmacist prescribing, care homes, polypharmacy, randomised controlled trial |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Pharmacy (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research R109149 |
Depositing User: | Symplectic Publications |
Date Deposited: | 11 Jun 2020 13:28 |
Last Modified: | 11 Jun 2020 13:28 |
Status: | Published |
Publisher: | BMC |
Identification Number: | 10.1186/s13063-020-04264-8 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:161716 |