Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data

Bruce Guthrie, Shaun Treweek, Dennis Petrie, Karen Barnett, Lewis D Ritchie, Chris Robertson, Marion Bennie, Bruce Guthrie, Shaun Treweek, Dennis Petrie, Karen Barnett, Lewis D Ritchie, Chris Robertson, Marion Bennie

Abstract

Introduction: High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback.

Methods and analysis: The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a 'usual care' arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices.

Ethics and dissemination: The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be disseminated via a final report to the funder with a publicly available research summary, and peer reviewed publications.

Trial registration: ClinicalTrials.gov, dossier number NCT01602705.

Figures

Figure 1
Figure 1
Effective Feedback to Improve Primary Care Prescribing Safety trial design.

References

    1. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ 2004;329:15–19
    1. Howard R, Avery A, Slavenburg S, et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 2007;63:136–47
    1. Avery A, Barber N, Ghaleb MA, et al. Investigating the prevalence and causes of prescribing errors in general practice: the PRACtICe study. Nottingham: University of Nottingham, 2012
    1. National Patient Safety Agency. Improving compliance with oral methotrexate guidelines. 2006. (accessed 6 December 2012).
    1. Medicines and Healthcare products Regulatory Agency and Commission on Human Medicines. Antipsychotics: use in elderly people with dementia. Drug Safety Update 2009;2.
    1. Higashi T, Shekelle P, Solomon DH, et al. The quality of pharmacological care for vulnerable older patients. Arch Intern Med 2004;140:714–20
    1. Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers’ criteria. Age Ageing 2008;37:673–9
    1. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers Criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716–24
    1. Dreischulte T, Grant A, McCowan C, et al. Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement. BMC Clin Pharmacol 2012;12:5.
    1. Guthrie B, McCowan C, Davey P, et al. High risk prescribing in primary care patients particularly vulnerable to adverse drug events: cross sectional population database analysis in Scottish general practice. BMJ 2011;342:d3514.
    1. Jamtvedt G, Young JM, Kristoffersen DT, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 1998;(1):CD000259, 2006
    1. Foy R, Eccles M, Jamtvedt G, et al. What do we know about how to do audit and feedback? Pitfalls in applying evidence from a systematic review. BMC Health Services Research 2005;5:50.
    1. Kiefe C, Allison J, Williams O, et al. Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial. JAMA 2001;285:2871–9
    1. Hysong SJ, Best R, Pugh J. Audit and feedback and clinical practice guideline adherence: making feedback actionable. Implement Sci 2006;1:9.
    1. Hysong SJ. Meta-analysis: audit and feedback features impact effectiveness on care quality. Med Care 2009;47:356–63
    1. Azjen I, Fishbein M. Questions raised by a reasoned action approach: comment on Ogden (2003). Health Psychol 2004;23:431–4
    1. Schwarzer R. Self-efficacy in the adoption and maintenance of health behaviors: theoretical approaches and a new model. In: Schwarzer R, ed. Self-efficacy: thought control of action. Washington, DC: Hemisphere, 1992:217–42
    1. Michie S, Johnston M, Francis J, et al. From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Appl Psychol Int Rev 2008;57:660–80
    1. Avery AJ, Dex GM, Mulvaney C, et al. Development of prescribing-safety indicators for GPs using the RAND appropriateness method. Br J Gen Pract 2011;61:e526–36
    1. Banerjee S. The use of antipsychotic medication for people with dementia: time for action. London: Department of Health, 2009
    1. Department of Health Government response to Professor Sube Banerjee's report on the prescribing of anti-psychotic drugs to people with dementia. London: Department of Health, 2009
    1. Thomas M. Diuretics, ACE inhibitors and NSAIDs—the triple whammy. Med J Aust 2000;172:184–5
    1. Loboz K, Shenfield G. Drug combinations and impaired renal function—the ‘triple whammy’. Br J Clin Pharmacol 2005;59:239–43
    1. NHS National Prescribing Centre Cardiovascular and gastrointestinal safety of NSAIDs, MeReC Extra2007;30
    1. NHS National Prescribing Centre Important updates on drug safety from the MHRA/CHM, MeReC Monthly 2009;16
    1. MacDonald TM, Morant S, Robinson G, et al. Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: cohort study. BMJ 1997;315:1333.
    1. Delaney JAM, Opatrny LMDM, Brophy JMMDP, et al. Drug drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding. Can Med Assoc J 2007;177:347–51
    1. NHS National Prescribing Centre. 2008. Update on the prescribing of NSAIDs. MeReC Monthly No 2.
    1. Donnar A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000
    1. Rotondi M. CRTSize version 0.2 Sample Size Estimation Functions for Cluster Randomized Trials. 2011. (accessed 6 December 2012).
    1. Office of the Chief Statistician Scottish index of multiple deprivation 2004 summary technical report. Edinburgh: Scottish Executive, 2004
    1. Avery AJ, Rodgers S, Cantrill JA, et al. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012;379:1310–9
    1. Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012;(6)::CD000259.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj