Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial

Jochen W L Cals, Rogier M Hopstaken, Christopher C Butler, Kerenza Hood, Johan L Severens, Geert-Jan Dinant, Jochen W L Cals, Rogier M Hopstaken, Christopher C Butler, Kerenza Hood, Johan L Severens, Geert-Jan Dinant

Abstract

Background: Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI) in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP) point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice.

Methods/design: This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation), and patient enablement.

Discussion: This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined. Evaluating a biomedical and communication based intervention ('hard' and 'soft' technologies) together in this way makes this trial unique in its field.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Desk reminders for GPs allocated to the CRP and/or communication skills interventions.

References

    1. Van der Velden J. Basisrapport morbiditeit in de huisartspraktijk. NIVEL; 1991.
    1. Verheij TJM, Salomé PL, Bindels PJ, Chavannes AW, Ponsioen BP, Sachs APE, Thiadens HA, Romeijnders ACM, Van Balen JAM. NHG-Standaard Acuut hoesten. [Dutch College of General Practitioners Guidelines on Acute Cough] Huisarts Wet. 2003;46:496–506.
    1. Steinman MA, Gonzales R, Linder JA, Landefeld CS. Changing Use of Antibiotics in Community-Based Outpatient Practice, 1991-1999. Ann Intern Med. 2003;138:525–533.
    1. van Duijn HJ, Kuyvenhoven MM, Schellevis FG, Verheij TJM. Determinants of prescribing of second-choice antibiotics for upper and lower respiratory tract episodes in Dutch general practice 10.1093/jac/dki214. J Antimicrob Chemother. 2005;56:420–422. doi: 10.1093/jac/dki214.
    1. Smucny J, Fahey T, Becker L, Glazier R. Antibiotics for acute bronchitis. Cochrane Database Syst Rev. 2004.
    1. Goossens H, Ferech M, Vander Stichele R, Elseviers M. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005;365:579–587.
    1. Welschen I, Kuyvenhoven MM, Hoes AW, Verheij TJM. Effectiveness of a multiple intervention to reduce antibiotic prescribing for respiratory tract symptoms in primary care: randomised controlled trial. BMJ. 2004;329:431. doi: 10.1136/bmj.38182.591238.EB.
    1. Coenen S, Van Royen P, Michiels B, Denekens J. Optimizing antibiotic prescribing for acute cough in general practice: a cluster-randomized controlled trial. J Antimicrob Chemother. 2004;54:661–672. doi: 10.1093/jac/dkh374.
    1. Gonzales R, Sande M. What will it take to stop physicians from prescribing antibiotics in acute bronchitis? Lancet. 1995;345:665–666. doi: 10.1016/S0140-6736(95)90861-7.
    1. Nordberg P, Monnet DL, Cars O. World Health Organization Department of Medicines Policy and Standards. Geneva ; 2005. Antibacterial drug resistance: options for concerted action; pp. 1–48.
    1. Hopstaken RM, Muris JWM, Knottnerus JA, Kester ADM, Rinkens PELM, Dinant GJ. Contributions of symptoms, signs, erythrocyte sedimentation rate and C-reactive protein to a diagnosis of pneumonia in acute lower respiratory tract infection. Br J Gen Pract. 2003;53:358–364.
    1. Melbye H, Straume B, Aasebo U, Dale K. Diagnosis of pneumonia in adults in general practice. Relative importance of typical symptoms and abnormal chest signs evaluated against a radiographic reference standard. Scand J Prim Health Care. 1992;10:226–233.
    1. Flanders SA, Stein J, Shochat G, Sellers K, Holland M, Maselli J, Drew WL, Reingold AL, Gonzales R. Performance of a bedside C-reactive protein test in the diagnosis of community-acquired pneumonia in adults with acute cough. Am J Med. 2004;116:529–535. doi: 10.1016/j.amjmed.2003.11.023.
    1. van der Meer V, Neven AK, Broek PJ, Assendelft WJJ. Diagnostic value of C reactive protein in infections of the lower respiratory tract: systematic review. BMJ. 2005;331:26–29. doi: 10.1136/bmj.38483.478183.EB.
    1. Hobbs FD, Kenkre JE, Carter YH, Thorpe GH, Holder RL. Reliability and feasibility of a near patient test for C-reactive protein in primary care. BMJ. 1996;46:395–400.
    1. Diederichsen HZ, Skamling M, Diederichsen A, Grinsted P, Antonsen S, Petersen PH, Munck AP, Kragstrup J. Randomised controlled trial of CRP rapid test as a guide to treatment of respiratory infections in general practice. Scand J Prim Health Care. 2000;18:39–43. doi: 10.1080/02813430050202541.
    1. Dahler Eriksen BS, Lauritzen T, Lassen JF, Lund ED, Brandslund I. Near-patient test for C-reactive protein in general practice: assessment of clinical, organizational, and economic outcomes. Clin Chem. 1999;45:478–485.
    1. Andre M, Schwan A, Odenholt I. The use of CRP tests in patients with respiratory tract infections in primary care in Sweden can be questioned. Scand J Infect Dis. 2004;36:192–197. doi: 10.1080/00365540410019372.
    1. Coenen S, Michiels B, Van Royen P, Van der Auwera JC, Denekens J. Antibiotics for coughing in general practice: a questionnaire study to quantify and condense the reasons for prescribing. BMC Fam Pract. 2002;3:16. doi: 10.1186/1471-2296-3-16.
    1. Hamm RM, Hicks RJ, Bemben DA. Antibiotics and respiratory infections: are patients more satisfied when expectations are met? J Fam Pract. 1996;43:56–62.
    1. Fischer T, Fischer S, Kochen MM, Hummers Pradier E. Influence of patient symptoms and physical findings on general practitioners' treatment of respiratory tract infections: a direct observation study. BMC Fam Pract. 2005;6:6. doi: 10.1186/1471-2296-6-6.
    1. Macfarlane J, Holmes W, Macfarlane R, Britten N. Influence of patients' expectations on antibiotic management of acute lower respiratory tract illness in general practice: questionnaire study. BMJ. 1997;315:1211–1214.
    1. Little P, Dorward M, Warner G, Stephens K, Senior J, Moore M. Importance of patient pressure and perceived pressure and perceived medical need for investigations, referral, and prescribing in primary care: nested observational study. BMJ. 2004;328:444. doi: 10.1136/bmj.38013.644086.7C.
    1. Petursson P. GPs' reasons for "non-pharmacological" prescribing of antibiotics. A phenomenological study. Scand J Prim Health Care. 2005;23:120–125.
    1. Cockburn J, Pit S. Prescribing behaviour in clinical practice: patients' expectations and doctors' perceptions of patients' expectations—a questionnaire study . BMJ. 1997;315:520–523.
    1. Rollnick S, Kinnersley P, Butler C. Context-bound communication skills training: development of a new method. Med Educ. 2002;36:377–383. doi: 10.1046/j.1365-2923.2002.01174.x.
    1. Little P, Gould C, Williamson I, Warner G, Gantley M, Kinmonth AL. Reattendance and complications in a randomised trial of prescribing strategies for sore throat: the medicalising effect of prescribing antibiotics . BMJ. 1997;315:350–352.
    1. Butler CC, Rollnick S, Kinnersley P, Tapper Jones L, Houston H. Communicating about expected course and re-consultation for respiratory tract infections in children: an exploratory study. Br J Gen Pract. 2004;54:536–538.
    1. Butler CC, Rollnick S, Kinnersley P, Jones A, Stott N. Reducing antibiotics for respiratory tract symptoms in primary care: consolidating 'why' and considering 'how'. Br J Gen Pract. 1998;48:1865–1870.
    1. Butler CC, Rollnick S, Pill R, Maggs Rapport F, Stott N. Understanding the culture of prescribing: qualitative study of general practitioners' and patients' perceptions of antibiotics for sore throats. BMJ. 1998;317:637–642.
    1. Rollnick S, Seale C, Kinnersley P, Rees M, Butler C, Hood K. Developing a new line of patter: can doctors change their consultations for sore throat? Medical Education. 2002;36:678–681. doi: 10.1046/j.1365-2923.2002.01255.x.
    1. Severens JL. Value for money of changing healthcare services? Economic evaluation of quality improvement 10.1136/qhc.12.5.366. Qual Saf Health Care. 2003;12:366–371. doi: 10.1136/qhc.12.5.366.
    1. Hopstaken RM. General Practice. Maastricht , Maastricht University; 2005. Lower respiratory tract infections in general practice; aetiology, diagnosis, management and prognosis; p. 191.
    1. Dahler Eriksen BS, Lassen JF, Petersen PH, Lund ED, Lauritzen T, Brandslund I. Evaluation of a near-patient test for C-reactive protein used in daily routine in primary healthcare by use of difference plots. Clin Chem. 1997;43:2064–2075.
    1. Little P, Rumsby K, Kelly J, Watson L, Moore M, Warner G, Fahey T, Williamson I. Information Leaflet and Antibiotic Prescribing Strategies for Acute Lower Respiratory Tract Infection: A Randomized Controlled Trial. JAMA. 2005;293:3029–3035. doi: 10.1001/jama.293.24.3029.
    1. Howie JG, Heaney DJ, Maxwell M, Walker JJ. A comparison of a Patient Enablement Instrument (PEI) against two established satisfaction scales as an outcome measure of primary care consultations. Fam Pract. 1998;15:165–171. doi: 10.1093/fampra/15.2.165.
    1. Goossens MEJB, Molken MPMHR, Vlaeyen JWS, van der Linden SMJP. The cost diary: a method to measure direct and indirect costs in cost-effectiveness research. J Clin Epidemiol. 2000;53:688–695. doi: 10.1016/S0895-4356(99)00177-8.
    1. Butler CC, Robling M, Prout H, Hood K, Kinnersley P. Management of suspected acute viral upper respiratory tract infection in children with intranasal sodium cromoglicate: a randomised controlled trial. The Lancet. 2002;359:2153–2158. doi: 10.1016/S0140-6736(02)09091-8.
    1. Barlow GD, Lamping DL, Davey PG, Nathwani D. Evaluation of outcomes in community-acquired pneumonia: a guide for patients, physicians, and policy-makers. The Lancet Infectious Diseases. 2003;3:476–488. doi: 10.1016/S1473-3099(03)00721-7.
    1. Mason J, Freemantle N, Nazareth I, Eccles M, Haines A, Drummond M. When Is It Cost-effective to Change the Behavior of Health Professionals? JAMA. 2001;286:2988–2992. doi: 10.1001/jama.286.23.2988.
    1. Campbell MJ. Extending CONSORT to include cluster trials. BMJ. 2004;328:654–655. doi: 10.1136/bmj.328.7441.654.
    1. Montgomery A, Peters T, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Medical Research Methodology. 2003;3:26. doi: 10.1186/1471-2288-3-26.
    1. P. L. Yudkin MM. Putting theory into practice: a cluster randomized trial with a small number of clusters. Statistics in Medicine. 2001;20:341–349. doi: 10.1002/1097-0258(20010215)20:3<341::AID-SIM796>;2-G.
    1. Campbell MK, Mollison J, Steen N, Grimshaw JM, Eccles M. Analysis of cluster randomized trials in primary care: a practical approach. Fam Pract. 2000;17:192–196. doi: 10.1093/fampra/17.2.192.

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