Evaluation of an interactive program for preventing adverse drug events in primary care: Study protocol of the InPAct cluster randomised stepped wedge trial

Implementation Science

Volumn 8, Issue 1, 2013, Pages

  Keriel Gascou, Maud ^a,b,c   Buchet Poyau, Karine ^d   Duclos, Antoine ^a,b,c,d   Rabilloud, Muriel ^a,d,e   Figon, Sophie ^a,b   Dubois, Jean Pierre ^a,b   Brami, Jean ^f   Vial, Thierry ^d   Colin, Cyrille ^a,b,c,d  

^a UNIVERSITÉ DE LYON   (France)

^b UNIVERSITÉ LYON 1   (France)

^c UNIVERSITÉ DE LYON   (France)

^d HOSPICES CIVILS DE LYON   (France)

^e LABORATOIRE DE BIOMÉTRIE ET BIOLOGIE EVOLUTIVE   (France)

^f UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

Adverse drug event; Antihypertensive drug; Cluster randomised controlled trial; Patient safety intervention; Primary health care; Stepped wedge

Indexed keywords

ANTIHYPERTENSIVE AGENT;

ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; CLUSTER ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SURVEILLANCE PROGRAM; EDUCATION; GENERAL PRACTICE; HUMAN; MEDICAL EDUCATION; METHODOLOGY; MIDDLE AGED; OUTCOME ASSESSMENT; PATIENT EDUCATION; PILOT STUDY; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; PROCEDURES;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; ANTIHYPERTENSIVE AGENTS; CLUSTER ANALYSIS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EDUCATION, MEDICAL, GRADUATE; GENERAL PRACTICE; HUMANS; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PAMPHLETS; PATIENT EDUCATION AS TOPIC; PILOT PROJECTS; YOUNG ADULT;

EID: 84879035949     PISSN: None     EISSN: 17485908     Source Type: Journal    
DOI: 10.1186/1748-5908-8-69     Document Type: Article

References (32)

1. Kingston-Riechers J, Ospina M, Jonsson E, Childs P, McLeod L, Maxted J. Patient safety in primary care 2010, Edmonton, AB: Canadian Patient Safety Institute and British Columbia Patient Safety and Quality Council.
2. Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. Adverse drug events in ambulatory care. N Engl J Med 2003, 348:1556-1564. 10.1056/NEJMsa020703, 12700376.
3. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003, 289:1107-1116. 10.1001/jama.289.9.1107, 12622580.
4. Smith PC, Araya-Guerra R, Bublitz C, Parnes B, Dickinson LM, Van Vorst R, Westfall JM, Pace WD. Missing clinical information during primary care visits. JAMA 2005, 293:565-571. 10.1001/jama.293.5.565, 15687311.
5. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med 2007, 2:314-323. 10.1002/jhm.228, 17935242.
6. WHO " Nine patient safety solutions" to help reduce the toll of health care-related harm affecting millions of patients worldwide 2007, Washington/Geneva: WHO Press, 2 may 2007, WHO.
7. De Langen J, Van Hunsel F, Passier A, De Jong-van den Berg L, Van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf 2008, 31:515-524. 10.2165/00002018-200831060-00006, 18484785.
8. Friedman SM, Provan D, Moore S, Hanneman K. Errors, near misses and adverse events in the emergency department: what can patients tell us?. CJEM 2008, 10:421-427.
9. McLernon DJ, Bond CM, Hannaford PC, Watson MC, Lee AJ, Hazell L, Avery A, Yellow Card Collaboration Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf 2010, 33:775-788. 10.2165/11536510-000000000-00000, 20701410, Yellow Card Collaboration.
10. Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf 2012, 35:807-818.
11. Fifth Joint Task Force of the European Society of Cardiology et al European Guidelines on cardiovascular disease prevention in clinical practice (version 2012): the Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur J Prev Cardiol 2012, 19:585-667. Fifth Joint Task Force of the European Society of Cardiology et al.
12. Runciman WB, Roughead EE, Semple SJ, Adams RJ. Adverse drug events and medication errors in Australia. Int J Qual Health Care 2003, 15(Suppl 1):i49-i59.
13. Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR, Cadoret C, Lee M, White K, LaPrino J, Erramuspe-Mainard J, DeFlorio M, Gavendo L, Auger J, Bates DW. The incidence of adverse drug events in two large academic long-term care facilities. Am J Med 2005, 118:251-258. 10.1016/j.amjmed.2004.09.018, 15745723.
14. Carbonin P, Pahor M, Bernabei R, Sgadari A. Is age an independent risk factor of adverse drug reactions in hospitalized medical patients?. J Am Geriatr Soc 1991, 39:1093-1099.
15. Brown C, Hofer T, Johal A, Thomson R, Nicholl J, Franklin BD, Lilford RJ. An epistemology of patient safety research: a framework for study design and interpretation. Part 4. One size does not fit all. Qual Saf Health Care 2008, 17:178-181. 10.1136/qshc.2007.023663, 18519623.
16. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006, 6:54. 10.1186/1471-2288-6-54, 1636652, 17092344.
17. Mdege ND, Man M-S, Taylor Nee Brown CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol 2011, 64:936-948. 10.1016/j.jclinepi.2010.12.003, 21411284.
18. Keriel-Gascou M, Badet-Phan A, Le Pogam M-A, Figon S, Letrilliart L, Gueyffier F, Buchet-Poyau K, Duclos A, Colin C. Information and active participation of the patient with an interactive booklet in primary care prescription of antihypertensives. Sante Publique 2013, 25:193-201.
19. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Publ Health 1984, 74:979-983.
20. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 2007, 28:182-191. 10.1016/j.cct.2006.05.007, 16829207.
21. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:e5661. 10.1136/bmj.e5661, 22951546.
22. Austin PC. Estimating multilevel logistic regression models when the number of clusters is low: a comparison of different statistical software procedures. Int J Biostat 2010, 6:16.
23. 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. 10.1136/bmj.a1655, 2769032, 18824488.
24. Weingart SN, Hamrick HE, Tutkus S, Carbo A, Sands DZ, Tess A, Davis RB, Bates DW, Phillips RS. Medication safety messages for patients via the web portal: the MedCheck intervention. Int J Med Inform 2008, 77:161-168. 10.1016/j.ijmedinf.2007.04.007, 17581772.
25. Roughead E, Pratt N, Peck R, Gilbert A. Improving medication safety: influence of a patient-specific prescriber feedback program on rate of medication reviews performed by Australian general medical practitioners. Pharmacoepidemiol Drug Saf 2007, 16:797-803. 10.1002/pds.1393, 17476702.
26. Fick DM, Maclean JR, Rodriguez NA, Short L, Heuvel RV, Waller JL, Rogers RL. A randomized study to decrease the use of potentially inappropriate medications among community-dwelling older adults in a southeastern managed care organization. Am J Manag Care 2004, 10:761-768.
27. Little P, Dorward M, Warner G, Moore M, Stephens K, Senior J, Kendrick T. Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. BMJ 2004, 328:441. 10.1136/bmj.37999.716157.44, 344265, 14966078.
28. Little P, Somerville J, Williamson I, Warner G, Moore M, Wiles R, George S, Smith A, Peveler R. Randomised controlled trial of self management leaflets and booklets for minor illness provided by post. BMJ 2001, 322:1214-1216. 1217, 10.1136/bmj.322.7296.1214, 31621, 11358775.
29. Little P, Griffin S, Kelly J, Dickson N, Sadler C. Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial. BMJ 1998, 316:1948-1952. 10.1136/bmj.316.7149.1948, 28594, 9641933.
30. Dawes MG, Kaczorowski J, Swanson G, Hickey J, Karwalajtys T. The effect of a patient education booklet and BP " tracker" on knowledge about hypertension. A randomized controlled trial. Fam Pract 2010, 27:472-478. 10.1093/fampra/cmq048, 20631056.
31. Pernod G, Labarère J, Yver J, Satger B, Allenet B, Berremili T, Fontaine M, Franco G, Bosson JL. EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study. J Gen Intern Med 2008, 23:1441-1446. 10.1007/s11606-008-0690-1, 2518037, 18566863.
32. Pearson D, Torgerson D, McDougall C, Bowles R. Parable of two agencies, one of which randomizes. ANNALS Am Acad Polit Soc Sci 2010, 628:11-29.