Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705)

Implementation Science

Bruce Guthrie⁵  Lewis D Ritchie⁴  Dennis J Petrie³  Christopher Robertson¹  Shaun Treweek⁷  Marion Bennie⁶  Karen N Barnett² 

[1] Department of Mathematics and Statistics, University of Strathclyde, Livingstone Tower 26 Richmond Street, Glasgow G1 1XH, UK;Centre of Population Health Sciences, University of Edinburgh Medical Quad, Teviot Place EH8 9AG, Edinburgh, UK;Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie Street, Victoria 3010, Australia;Centre of Academic Primary Care, School of Medicine and Dentistry, University of Aberdeen, Polwarth Building, Foresterhill AB25 2ZD, Aberdeen, UK;Quality, Safety and Informatics Research Group, University of Dundee, Mackenzie Building, Kirsty Semple Way, Dundee DD2 4BF, UK;Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, The John Arbuthnott Building, 161 Cathedral Street, Glasgow G4 ORE, UK;Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill AB25 2ZD, Aberdeen, UK

关键词: ePrescribing;    Behaviour change;    Intervention development;    Family practice;    Primary health care;    Randomised controlled trial;    Inappropriate medication;    Medication review;    Medication errors;    Feedback;   

Others  :  1139533
DOI  :  10.1186/s13012-014-0133-9

 received in 2014-03-17, accepted in 2014-09-19,  发布年份 2014

【 摘 要 】

Background

High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.

Methods

The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.

Results

Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).

Conclusions

The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.

Trial registration

ClinicalTrials.gov: NCT01602705 webcite

【 授权许可】

   
2014 Barnett et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM: Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004, 329:15-19.
• [2]Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Cresswell K, Eden M, Elliott RA, Howard R, Kendrick D, Morris CJ, Prescott RJ, Swanwick G, Franklin M, Putman K, Boyd M, Sheikh A: A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012, 379:1310-1319.
• [3]Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M: Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 2007, 63:136-147.
• [4]Higashi T, Shekelle PG, Solomon DH, Knight EL, Roth C, Chang JT, Kamberg CJ, MacLean CH, Young RT, Adams J, Reuben DB, Avorn J, Wenger NS: The quality of pharmacologic care for vulnerable older patients. Ann Intern Med 2004, 140:714-720.
• [5]Fick D, Semla T, Beizer J, Brandt N, Dombrowski R, DuBeau CE, Flanigan N, Hanlon J, Hollman P, Linnebur S, Nau D, Rehm B, Sandhu S, Steinman M: American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012, 60:616-631.
• [6]Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH: Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med 2003, 163:2716-2724.
• [7]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, 37:673-679.
• [8]Avery AJ, Dex GM, Mulvaney C, Serumaga B, Spencer R, Lester HE, Campbell SM: Development of prescribing-safety indicators for GPs using the RAND Appropriateness Method. Br J Gen Pract 2011, 61:e526-e536.
• [9]Dreischulte T, Grant AM, McCowan C, McAnaw JJ, Guthrie B: 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. BioMed Central Full Text
• [10]Guthrie B, McCowan C, Davey P, Simpson CR, Dreischulte T, Barnett K: High risk prescribing in primary care patients particularly vulnerable to adverse drug events: cross sectional population database analysis in Scottish general practice. BMJ (Clinical research ed) 2011, 342:d3514.
• [11]Jamtvedt G, Young JM, Kristoffersen DT, O¿Brien MA, Oxman AD: Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2006, 2:CD000259.
• [12]Foy R, Eccles MP, Jamtvedt G, Young J, Grimshaw JM, Baker R: What do we know about how to do audit and feedback? Pitfalls in applying evidence from a systematic review. BMC Health Serv Res 2005, 5:50. BioMed Central Full Text
• [13]Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O¿Brien MA, Johansen M, Grimshaw J, Oxman AD: Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012, 6:CD000259.
• [14]Behaviour change at population, community and individual levels (Public Health Guidance 6). NICE, London; 2007.
• [15]French SD, Green SE, O¿Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM: Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci 2012, 7:38-54. BioMed Central Full Text
• [16]Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A: Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005, 14:26-33.
• [17]Michie S, Johnston M, Francis J, Hardeman W, Eccles M: From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Applied Psychology-an International Review-Psychologie Appliquee-Revue Internationale 2008, 57:660-680.
• [18]Guthrie B, Treweek S, Petrie D, Barnett K, Ritchie LD, Robertson C, Bennie M: Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data. BMJ Open 2012, 2:1-10.
• [19]Armitage CJ, Conner M: Social cognition models and health behaviour: a structured review. Psychol Health 2000, 15:173-189.
• [20]Ajzen I: The theory of planned behavior. Organ Behav Hum Decis Process 1991, 50:179-211.
• [21]Godin G, Kok G: The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot 1996, 11:87-98.
• [22]Hausenblas HA, Carron AV, Mack DE: Application of the theories of reasoned action and planned behavior to exercise behavior: a meta-analysis. J Sport Exerc Psychol 1997, 19:36-51.
• [23]Francis JJ, Eccles MP, Johnston M, Walker A, Grimshaw J, Foy R, Kaner EFS, Smith L, Bonetti D: Constructing questionnaires based on the theory of planned behaviour. Man Health Serv Res 2004, 2010:2-12.
• [24]Sheeran P, Orbell S: Do intentions predict condom use? Meta-analysis and examination of six moderator variables. Br J Soc Psychol 1998, 37(Pt 2):231-250.
• [25]Schwarzer R: Self-Efficacy: Thought Control of Action. Hemisphere Publishing Corp, Washington, DC, US; 1992.
• [26]Dreischulte T, Grant A, Donnan P, McCowan C, Davey P, Petrie D, Treweek S, Guthrie B: A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: The DQIP study protocol. Implement Sci 2012, 7:1-13. BioMed Central Full Text
• [27]Schulz KF, Altman DG, Moher D, Grp C: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010, 63:834-840.
• [28]Michie S, Fixsen D, Grimshaw JM, Eccles MP: Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci 2009, 4:1-6. BioMed Central Full Text
• [29]Albrecht L, Archibald M, Arseneau D, Scott SD: Development of a checklist to assess the quality of reporting of knowledge translation interventions using the Workgroup for Intervention Development and Evaluation Research (WIDER) recommendations. Implement Sci 2013, 8:1-5. BioMed Central Full Text
• [30]Davies P, Walker AE, Grimshaw JM: A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implementation Sci 2010, 5:14. BioMed Central Full Text