Study protocol

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Anthony J Avery¹ , Sarah Rodgers² , Judith A Cantrill³ , Sarah Armstrong⁴ , Rachel Elliott² , Rachel Howard⁵ , Denise Kendrick¹ , Caroline J Morris⁶ , Scott A Murray⁷ , Robin J Prescott⁷ , Kathrin Cresswell⁷ and Aziz Sheikh⁷

¹  Division of Primary Care, The Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, UK

²  Division for Social Research in Medicines and Health, The School of Pharmacy, University of Nottingham, University Park, Nottingham, NG7 2RD, UK

³  Drug Usage & Pharmacy Practice Group, School of Pharmacy & Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester, M13 9PL, UK

⁴  Trent Research Design Service, Division of Primary Care, Tower Building, University Park, Nottingham, NG7 2RD, UK

⁵  School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK

⁶  Department of Primary Health Care and General Practice, Wellington School of Medicine and Health Sciences, University of Otago, Mein Street, Wellington South, New Zealand

⁷  Centre for Population Health Sciences, University of Edinburgh, 20 West Richmond Street, Edinburgh, EH8 9DX, UK

author email corresponding author email

Trials 2009, 10:28doi:10.1186/1745-6215-10-28

Published:	1 May 2009

Abstract

Background

Medication errors are an important cause of morbidity and mortality in primary care.

The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family) practice.

Methods

Research subject group: "At-risk" patients registered with computerised general practices in two geographical regions in England.

Design: Parallel group pragmatic cluster randomised trial.

Interventions: Practices will be randomised to either: (i) Computer-generated feedback; or (ii) Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support.

Primary outcome measures: The proportion of patients in each practice at six and 12 months post intervention:

- with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs

- with a computer-recorded diagnosis of asthma being prescribed beta-blockers

- aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months.

Secondary outcome measures; These relate to a number of other examples of potentially hazardous prescribing and medicines management.

Economic analysis: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS), comparing the pharmacist-led intervention with simple feedback.

Qualitative analysis: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove ineffective.

Sample size: 34 practices in each of the two treatment arms would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a 50% reduction in error rates for each of the three primary outcome measures in the pharmacist-led intervention arm compared with a 11% reduction in the simple feedback arm.

Discussion

At the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken.

Trial registration

Current controlled trials ISRCTN21785299