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

Christine Bond* (Corresponding Author), Richard Holland, David P. Alldred, Antony Arthur, Garry Baton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M Poland, Lee Shepstone, Arnold Zermansky, David WrightCHIPPS Team

*Corresponding author for this work

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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.

To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time.

To explore the effects of individual intervention components on the primary outcomes.

To investigate the mechanisms of impact.

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.

To describe the characteristics of GP, care home, PIP and resident participants to assess reach.

To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff.

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.

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.
Original languageEnglish
Article number439
Pages (from-to)439
Number of pages10
Issue number1
Publication statusPublished - 29 May 2020

Bibliographical note

This study is funded by the NIHR [Programme Grants for Applied Research (grant reference number RP-PG-0613-20007)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Other than receiving routine monitoring reports, the funders have had no further involvement in the design and conduct of the trial or any input to this manuscript. A copy of the manuscript has been sent to them for information.

We thank the members of the research team who have or are contributing daily to deliver the process evaluation (University of East Anglia: Laura Watts, Joanna Williams, Bronwen Harry, Jeanette Blacklock, Caroline Hill, Frances Johnston; University of Aberdeen: Jacqueline Inch, Frances Notman, Lindsay Dalgarno; University of Leeds: Amrit Daffu-O'Reilly; Queen's University Belfast: Mairead McGrattan); PPIRes (Public and Patient Involvement in Research) for being formal collaborators on the grant and for advice on ongoing conduct of the study as represented by Kate Massey (sadly deceased) and Christine Handford. We thank Ian Small lead primary care medicines management pharmacist in Norwich (now retired) and a co-applicant on the National Institute of Health Research (NIHR) programme grant. On behalf of the CHIPPS Team, we would also like to acknowledge NHS South Norfolk Clinical Commissioning Group (CCG) as the study sponsor and host of PPIRes, and especially Clare Symms, Norfolk & Suffolk Primary and Community Care Research Office for her contribution towards management of the study budget.


  • older people
  • pharmacist prescribing
  • care homes
  • polypharmacy
  • randomised controlled trial
  • Older people


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