Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol
Introduction Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD s...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e079110.full |
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| author | Natasa Gisev Sanjyot Vagholkar Kamal Sud Judy Mullan Ines Krass Anh Tran Rita McMorrow Wubshet Tesfaye David W. Johnson Connie Van Vincent L. Versace Judith Fethney Breonny Robson Lukas Kairaitis Mariam Fathima Vivien Tong Natali Coric Ronald L. Castelino |
| author_facet | Natasa Gisev Sanjyot Vagholkar Kamal Sud Judy Mullan Ines Krass Anh Tran Rita McMorrow Wubshet Tesfaye David W. Johnson Connie Van Vincent L. Versace Judith Fethney Breonny Robson Lukas Kairaitis Mariam Fathima Vivien Tong Natali Coric Ronald L. Castelino |
| author_sort | Natasa Gisev |
| collection | DOAJ |
| description | Introduction Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.Methods and analysis This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.Ethics and dissemination The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12622000329763). |
| format | Article |
| id | doaj-art-2fc918aa61814706ad99bd38f623dbc9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2fc918aa61814706ad99bd38f623dbc92025-08-20T03:48:43ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-079110Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocolNatasa Gisev0Sanjyot Vagholkar1Kamal Sud2Judy Mullan3Ines Krass4Anh Tran5Rita McMorrow6Wubshet Tesfaye7David W. Johnson8Connie Van9Vincent L. Versace10Judith Fethney11Breonny Robson12Lukas Kairaitis13Mariam Fathima14Vivien Tong15Natali Coric16Ronald L. Castelino17National Drug and Alcohol Research Centre, University of New South Wales Sydney, Sydney, New South Wales, AustraliaMQ Health General Practice, Macquarie University, North Ryde, New South Wales, AustraliaNepean Kidney Research Centre, Department of Renal Medicine, Nepean Hospital, Sydney, New South Wales, AustraliaGraduate School of Medicine, University of Wollongong, Wollongong, New South Wales, Australia6 Faculty of Pharmacy, University of Sydney, Sydney, New South Wales, AustraliaNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia1 Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Victoria, AustraliaHealth research Institute, University of Canberra, Canberra, Australian Capital Territory, AustraliaCentre for Health Services Research, The University of Queensland Faculty of Medicine, Brisbane, Queensland, AustraliaThe University of Sydney School of Pharmacy, Sydney, New South Wales, AustraliaDeakin Rural Health, School of Medicine, Faculty of Health, Deakin University, Melbourne, Victoria, AustraliaSusan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaKidney Health Australia, Melbourne, Victoria, AustraliaDepartment of Renal Medicine, Blacktown Hospital, Sydney, New South Wales, AustraliaThe University of Sydney School of Pharmacy, Sydney, New South Wales, AustraliaThe University of Sydney School of Pharmacy, Sydney, New South Wales, AustraliaDepartment of General Practice and Primary Care, The University of Melbourne, Melbourne, Victoria, AustraliaThe University of Sydney School of Pharmacy, Sydney, New South Wales, AustraliaIntroduction Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.Methods and analysis This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.Ethics and dissemination The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).https://bmjopen.bmj.com/content/13/12/e079110.full |
| spellingShingle | Natasa Gisev Sanjyot Vagholkar Kamal Sud Judy Mullan Ines Krass Anh Tran Rita McMorrow Wubshet Tesfaye David W. Johnson Connie Van Vincent L. Versace Judith Fethney Breonny Robson Lukas Kairaitis Mariam Fathima Vivien Tong Natali Coric Ronald L. Castelino Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol BMJ Open |
| title | Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol |
| title_full | Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol |
| title_fullStr | Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol |
| title_full_unstemmed | Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol |
| title_short | Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol |
| title_sort | impact of a pharmacy led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting a cluster randomised trial protocol |
| url | https://bmjopen.bmj.com/content/13/12/e079110.full |
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