Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

Elizabeth Murray, Shaun Treweek, Catherine Pope, Anne MacFarlane, Luciana Ballini, Christopher Dowrick, Tracy Finch, Anne Kennedy, Frances Mair, Catherine O'Donnell, Bie Nio Ong, Tim Rapley, Anne Rogers, Carl May, Elizabeth Murray, Shaun Treweek, Catherine Pope, Anne MacFarlane, Luciana Ballini, Christopher Dowrick, Tracy Finch, Anne Kennedy, Frances Mair, Catherine O'Donnell, Bie Nio Ong, Tim Rapley, Anne Rogers, Carl May

Abstract

Background: The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation).

Discussion: In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential.

Summary: The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

Figures

Figure 1
Figure 1
Normalisation Process Theory (NPT) as a 'trial killer'. Context: All important for development, evaluation and implementation.

References

    1. MRC Health Services and Public Health Research Board. A Framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. London, Medical Research Council; 2000. pp. 1–18.
    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334:455–459. doi: 10.1136/.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Hardeman W, Sutton S, Griffin S, Johnston M, White A, Wareham NJ, Kinmonth AL. A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Health Educ Res. 2005;20:676–687. doi: 10.1093/her/cyh022.
    1. Michie S, Fixsen D, Grimshaw JM, Eccles MP. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci. 2009;4:40. doi: 10.1186/1748-5908-4-40.
    1. Eldridge S, Spencer A, Cryer C, Parsons S, Underwood M, Feder G. Why modelling a complex intervention is an important precursor to trial design: lessons from studying an intervention to reduce falls-related injuries in older people. J Health Serv Res Policy. 2005;10:133–142. doi: 10.1258/1355819054338942.
    1. Lovell K, Bower P, Richards D, Barkham M, Sibbald B, Roberts C, Davies L, Rogers A, Gellatly J, Hennessy S. Developing guided self-help for depression using the Medical Research Council complex interventions framework: a description of the modelling phase and results of an exploratory randomised controlled trial. BMC Psychiatry. 2008;8:91. doi: 10.1186/1471-244X-8-91.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332:413–416. doi: 10.1136/bmj.332.7538.413.
    1. Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496. doi: 10.1136/bmj.b3496.
    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A, Grant A. STEPS group. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess. 2007;11(iii):ix–105.
    1. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients' care. Lancet. 2003;362:1225–1230. doi: 10.1016/S0140-6736(03)14546-1.
    1. Cooksey D. A Review of UK Health Research Funding. London, HMSO; 2006.
    1. Woolf SH. The meaning of translational research and why it matters. JAMA. 2008;299:211–213. doi: 10.1001/jama.2007.26.
    1. Presseau J, Sniehotta FF, Francis JJ, Campbell NC. Multiple goals and time constraints: perceived impact on physicians' performance of evidence-based behaviours. Implement Sci. 2009;4:77. doi: 10.1186/1748-5908-4-77.
    1. Petticrew M, Whitehead M, Macintyre SJ, Graham H, Egan M. Evidence for public health policy on inequalities: 1. The reality according to policymakers. J Epidemiol Community Health. 2004;58:811–816. doi: 10.1136/jech.2003.015289.
    1. May C. Mobilising modern facts: health technology assessment and the politics of evidence. Sociol Health Illn. 2006;28:513–532. doi: 10.1111/j.1467-9566.2006.00505.x.
    1. Pick W. Lack of evidence hampers human-resources policy making. Lancet. 2008;371:629–630. doi: 10.1016/S0140-6736(08)60280-9.
    1. Eccles MP, Armstrong D, Baker R, Cleary K, Davies H, Davies S, Glasziou P, Ilott I, Kinmonth AL, Leng G, Logan S, Marteau T, Michie S, Rogers H, Rycroft-Malone J, Sibbald B. An implementation research agenda. Implementation Science. 2009;4:18. doi: 10.1186/1748-5908-4-18.
    1. May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, Murray E, Elwyn G, Légaré F, Gunn J, Montori VM. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci. 2009;4:29. doi: 10.1186/1748-5908-4-29.
    1. May C, Finch T. Implementation, embedding, and integration: an outline of Normalization Process Theory. Sociology. 2009;43:535–554. doi: 10.1177/0038038509103208.
    1. Petersen I, Johnson AM, Islam A, Duckworth G, Livermore DM, Hayward AC. Protective effect of antibiotics against serious complications of common respiratory tract infections: retrospective cohort study with the UK General Practice Research Database. BMJ. 2007;335:982. doi: 10.1136/.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. CONSORT group: Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Tooth S, Ong BN, Foster NE. Using a conceptual framework to study the introduction of a new approach to the assessment and treatment of low back pain in primary care. International Forum X for Low Back Pain Research in Primary Care 06.06.09.; Boston, USA.
    1. May C, Montori VM, Mair FS. We need minimally disruptive medicine. BMJ. 2009;339:b2803. doi: 10.1136/bmj.b2803.
    1. Kennedy A, Chew-Graham C, Blakeman T, Bowen A, Gardner C, Protheroe J, Rogers A, Gask L. Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation. Implement Sci. 2010;5:7. doi: 10.1186/1748-5908-5-7.
    1. Roland M. Linking physicians' pay to the quality of care: a major experiment in the United Kingdom. N Engl J Med. 2004;351:1448–1454. doi: 10.1056/NEJMhpr041294.
    1. McKinstry B, Hammersley V, Daly F, Sullivan F. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: a case study. BMC Med Res Methodol. 2007;7:15. doi: 10.1186/1471-2288-7-15.
    1. Peto V, Coulter A, Bond A. Factors affecting general practitioners' recruitment of patients into a prospective study. Fam Pract. 1993;10:207–211. doi: 10.1093/fampra/10.2.207.
    1. Fairhurst K, Dowrick C. Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications. J Health Serv Res Policy. 1996;1:77–80.
    1. Shapiro SP. Agency theory. Annu Rev Sociol. 2005;31:263–284. doi: 10.1146/annurev.soc.31.041304.122159.
    1. Ajzen I. The theory of planned behavior. Org Behav Human Decision Proc. 1991;50:179–211. doi: 10.1016/0749-5978(91)90020-T.
    1. Hechter M, Kanazawa S. Sociological rational choice theory. Annu Rev Sociol. 1997;23:191–214. doi: 10.1146/annurev.soc.23.1.191.
    1. Rogers EM. Diffusion of Innovations. 4. New York: The Free Press, Simon & Schuster Inc; 1995.
    1. May C. The hard work of being ill. Chronic Illn. 2006;2:161–162.
    1. Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010;3:CD005470.
    1. Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009;55:1037–1063. doi: 10.1016/j.eururo.2009.01.036.

Source: PubMed

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