Predictive risk stratification model: a progressive cluster-randomised trial in chronic conditions management (PRISMATIC) research protocol

Trials

Helen A Snooks²  Alan Watkins²  Daniel Warm⁴  Bernadette Sewell³  Ian T Russell²  Alison Porter²  Ceri Phillips³  Leo Lewis⁴  Mark-Rhys Kingston²  Peter Huxley¹  Martin Heaven²  Jane Harrison⁵  Deborah Fitzsimmons³  Bridie A Evans²  Hayley A Hutchings² 

[1] Mental Health Research Team, College of Medicine and College of Human and Health Sciences, Swansea University, Singleton Park, Swansea SA2 8PP, UK;Centre for Health Information Research and Evaluation (CHIRAL), College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP, UK;Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Singleton Park, Swansea SA2 8PP, UK;NHS Wales Informatics Services, 10-11 Old Field Road, Bocam Park, Pencoed CF35 5LJ, UK;Abertawe Bro Morgannwg University Health Board, Morriston Hospital, Morriston, Swansea SA6 6NL, UK

关键词: Stepped wedge randomised trial;    Primary care;    Chronic disease;    Clinical prediction models;    Predictive risk stratification;   

Others  :  1093046
DOI  :  10.1186/1745-6215-14-301

 received in 2013-06-05, accepted in 2013-09-09,  发布年份 2013

【 摘 要 】

Background

An ageing population increases demand on health and social care. New approaches are needed to shift care from hospital to community and general practice. A predictive risk stratification tool (Prism) has been developed for general practice that estimates risk of an emergency hospital admission in the following year. We present a protocol for the evaluation of Prism.

Methods/Design

We will undertake a mixed methods progressive cluster-randomised trial. Practices begin as controls, delivering usual care without Prism. Practices will receive Prism and training randomly, and thereafter be able to use Prism with clinical and technical support. We will compare costs, processes of care, satisfaction and patient outcomes at baseline, 6 and 18 months, using routine data and postal questionnaires. We will assess technical performance by comparing predicted against actual emergency admissions. Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers. We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups. We will take account of covariates and explanatory factors. In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis. We will also examine changes in quality of life of patients across the risk spectrum. We will record and transcribe focus groups and interviews and analyse them thematically. We have received full ethical and R&D approvals for the study and Information Governance Review Panel (IGRP) permission for the use of routine data. We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals.

Discussion

The proposed study will provide information on costs and effects of Prism; how it is used in practice, barriers and facilitators to its implementation; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions.

Trial registration

Controlled Clinical Trials ISRCTN no. ISRCTN55538212.

【 授权许可】

   
2013 Hutchings et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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