scholarly journals Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE)

2020 ◽  
Vol 2 ◽  
pp. 20 ◽  
Author(s):  
Karen Kyne ◽  
Caroline McCarthy ◽  
Bridget Kiely ◽  
Susan M. Smith ◽  
Barbara Clyne ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Quantitative Data ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Inappropriate Prescribing ◽  
Cluster Randomised Controlled Trial ◽  
Potentially Inappropriate Prescribing ◽  
Randomised Controlled ◽  
Mechanism Of Impact

Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016

scholarly journals Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE)

2019 ◽  
Vol 2 ◽  
pp. 20 ◽  
Author(s):  
Karen Kyne ◽  
Caroline McCarthy ◽  
Bridget Kiely ◽  
Susan M. Smith ◽  
Barbara Clyne ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Quantitative Data ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Inappropriate Prescribing ◽  
Cluster Randomised Controlled Trial ◽  
Potentially Inappropriate Prescribing ◽  
Randomised Controlled ◽  
Mechanism Of Impact

Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016

scholarly journals Integrating clinical pharmacists within general practice: protocol for a pilot cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041541
Author(s):  
Aisling Croke ◽  
Frank Moriarty ◽  
Fiona Boland ◽  
Laura McCullagh ◽  
Karen Cardwell ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Inappropriate Prescribing ◽  
Cluster Randomised Controlled Trial ◽  
Potentially Inappropriate Prescribing ◽  
Cluster Randomised ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionManaging patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.Methods and analysisThis pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.Ethics and disseminationThis trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.Trial registration numberISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

scholarly journals Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033552 ◽  
Author(s):  
April Morrow ◽  
Katherine M Tucker ◽  
Tim J Shaw ◽  
Bonny Parkinson ◽  
Charles Abraham ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Lynch Syndrome ◽  
Process Evaluation ◽  
Implementation Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Successful Implementation ◽  
Implementation Success ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionIn multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project (‘HaSP’) is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial.Methods and analysisA mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre–post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor’s implementation outcomes.Ethics and disseminationUse of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties.HaSP trial registration numberAustralian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.

Understanding implementation factors and participant experiences of a cluster randomised controlled trial to prevent falls among older Aboriginal people: a process evaluation protocol

2021 ◽  
pp. injuryprev-2020-043980
Author(s):  
Rona Macniven ◽  
Julieann Coombes ◽  
Roland Wilson ◽  
Aaron Simon ◽  
Tamara Mackean ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Aboriginal People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mixed Methods Design ◽  
Programme Implementation ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionProcess evaluations examining programme implementation are often conducted in conjunction with effectiveness studies. Their inclusion in studies with Aboriginal participants can give an understanding of programme delivery in Aboriginal community contexts. The Ironbark: Standing Strong and Tall programme was codesigned with Aboriginal communities and includes exercise and facilitated ‘yarning’ discussion about fall risk and prevention strategies. The programme pilot showed favourable outcomes and acceptability for Aboriginal people aged 45 years and over. The Ironbark: Standing Strong and Tall programme is now being compared with a ‘Healthy Community’ programme in a cluster randomised controlled trial within Aboriginal health and community services. An embedded process evaluation aims to explore relationships between participation and programme outcomes and the quality of programme implementation.Methods and analysisThe process evaluation will use a mixed methods design, guided by Indigenous research methodology. It will evaluate quantitative data (number of completed sessions, site coaching checklist tool, participant and facilitator questionnaire data and a participant habit formation scale), as well as qualitative data (open-ended responses from project and site staff and semistructured interviews using yarning with study participants and site managers). A programme logic model was developed to explain the intended inputs, activities, outputs and outcomes, which guided this process evaluation design.ConclusionThis process evaluation of a fall prevention programme for older Aboriginal people using a mixed methods design and data triangulation will allow for a comprehensive understanding of study findings. Multiple study sites allow for generalisability of findings and exploration of variation across sites.Trial registration numberACTRN12619000349145.

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