Skip to main content
Top
Published in: Implementation Science 1/2011

Open Access 01-12-2011 | Research article

Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

Authors: Annie LeBlanc, France Légaré, Michel Labrecque, Gaston Godin, Robert Thivierge, Claudine Laurier, Luc Côté, Annette M O'Connor, Michel Rousseau

Published in: Implementation Science | Issue 1/2011

Login to get access

Abstract

Background

The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs) are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care.

Methods

A pilot clustered randomised trial was conducted. Family medicine groups (FMGs) were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program.

Results

Among 21 FMGs contacted, 5 (24%) agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs) and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group), and the overall mean level of satisfaction regarding the workshops was 94%.

Conclusions

This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians interested in designing and/or conducting studies with FMGs regarding training of physicians in shared decision-making.

Trial Registration

Clinicaltrials.Gov NCT00354315
Appendix
Available only for authorised users
Literature
1.
go back to reference Steinman MA, Ranji SR, Shojania KG, Gonzales R: Improving antibiotic selection: a systematic review and quantitative analysis of quality improvement strategies. Med Care. 2006, 44 (7): 617-628. 10.1097/01.mlr.0000215846.25591.22.CrossRefPubMed Steinman MA, Ranji SR, Shojania KG, Gonzales R: Improving antibiotic selection: a systematic review and quantitative analysis of quality improvement strategies. Med Care. 2006, 44 (7): 617-628. 10.1097/01.mlr.0000215846.25591.22.CrossRefPubMed
2.
go back to reference Arnold SR, Straus SE: Interventions to improve antibiotic prescribing practices in ambulatory care. Cochrane Database Syst Rev. 2005, CD003539-4PubMed Arnold SR, Straus SE: Interventions to improve antibiotic prescribing practices in ambulatory care. Cochrane Database Syst Rev. 2005, CD003539-4PubMed
3.
go back to reference Glasziou PP, Del Mar CB, Sanders SL, Hayem M: Antibiotics for acute otitis media in children. Cochrane Database Syst Rev. 2004, CD000219-1PubMed Glasziou PP, Del Mar CB, Sanders SL, Hayem M: Antibiotics for acute otitis media in children. Cochrane Database Syst Rev. 2004, CD000219-1PubMed
4.
go back to reference Spurling GK, Del Mar CB, Dooley L, Foxlee R: Delayed antibiotics for symptoms and complications of respiratory infections. Cochrane Database Syst Rev. 2004, CD004417-4PubMed Spurling GK, Del Mar CB, Dooley L, Foxlee R: Delayed antibiotics for symptoms and complications of respiratory infections. Cochrane Database Syst Rev. 2004, CD004417-4PubMed
5.
go back to reference Butler CC, Kinnersley P, Prout H, Rollnick S, Edwards A, Elwyn G: Antibiotics and shared decision-making in primary care. J Antimicrob Chemother. 2001, 48 (3): 435-440. 10.1093/jac/48.3.435.CrossRefPubMed Butler CC, Kinnersley P, Prout H, Rollnick S, Edwards A, Elwyn G: Antibiotics and shared decision-making in primary care. J Antimicrob Chemother. 2001, 48 (3): 435-440. 10.1093/jac/48.3.435.CrossRefPubMed
7.
go back to reference Charles C, Gafni A, Whelan T: Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997, 44 (5): 681-692. 10.1016/S0277-9536(96)00221-3.CrossRefPubMed Charles C, Gafni A, Whelan T: Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997, 44 (5): 681-692. 10.1016/S0277-9536(96)00221-3.CrossRefPubMed
8.
go back to reference O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2009, CD001431-3 O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2009, CD001431-3
9.
go back to reference Legare F, Ratte S, Gravel K, Graham ID: Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals' perceptions. Patient Educ Couns. 2008, 73 (3): 526-535. 10.1016/j.pec.2008.07.018.CrossRefPubMed Legare F, Ratte S, Gravel K, Graham ID: Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals' perceptions. Patient Educ Couns. 2008, 73 (3): 526-535. 10.1016/j.pec.2008.07.018.CrossRefPubMed
10.
go back to reference Légaré F, Ratté S, Stacey D, Kryworuchko J, Gravel K, Turcot L, Graham I: Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database of Syst Rev. 2010, 12 (5): CD006732- Légaré F, Ratté S, Stacey D, Kryworuchko J, Gravel K, Turcot L, Graham I: Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database of Syst Rev. 2010, 12 (5): CD006732-
11.
go back to reference Legare F, Moher D, Elwyn G, LeBlanc A, Gravel K: Instruments to assess the perception of physicians in the decision-making process of specific clinical encounters: a systematic review. BMC Med Inform Decis Mak. 2007, 7: 30-10.1186/1472-6947-7-30.CrossRefPubMedPubMedCentral Legare F, Moher D, Elwyn G, LeBlanc A, Gravel K: Instruments to assess the perception of physicians in the decision-making process of specific clinical encounters: a systematic review. BMC Med Inform Decis Mak. 2007, 7: 30-10.1186/1472-6947-7-30.CrossRefPubMedPubMedCentral
12.
go back to reference LeBlanc A, Kenny DA, O'Connor AM, Legare F: Decisional conflict in patients and their physicians: a dyadic approach to shared decision making. Med Decis Making. 2009, 29 (1): 61-68. 10.1177/0272989X08327067.CrossRefPubMed LeBlanc A, Kenny DA, O'Connor AM, Legare F: Decisional conflict in patients and their physicians: a dyadic approach to shared decision making. Med Decis Making. 2009, 29 (1): 61-68. 10.1177/0272989X08327067.CrossRefPubMed
13.
go back to reference Legare F, O'Connor AM, Graham ID, Wells GA, Tremblay S: Impact of the Ottawa Decision Support Framework on the Agreement and the Difference between Patients' and Physicians' Decisional Conflict. Med Decis Making. 2006, 26 (4): 373-390. 10.1177/0272989X06290492.CrossRefPubMed Legare F, O'Connor AM, Graham ID, Wells GA, Tremblay S: Impact of the Ottawa Decision Support Framework on the Agreement and the Difference between Patients' and Physicians' Decisional Conflict. Med Decis Making. 2006, 26 (4): 373-390. 10.1177/0272989X06290492.CrossRefPubMed
14.
go back to reference Kenny DA, Veldhuijzen W, Weijden Tvd, LeBlanc A, Lockyer J, Légaré F, Campbell C: Interpersonal perception in the context of doctor-patient relationships: A dyadic analysis of doctor-patient communication. Social Science & Medicine. 2010, 70 (5): 763-8.CrossRef Kenny DA, Veldhuijzen W, Weijden Tvd, LeBlanc A, Lockyer J, Légaré F, Campbell C: Interpersonal perception in the context of doctor-patient relationships: A dyadic analysis of doctor-patient communication. Social Science & Medicine. 2010, 70 (5): 763-8.CrossRef
15.
go back to reference Veitch C, Hollins J, Worley P, Mitchell G: General practice research. Problems and solutions in participant recruitment and retention. Aust Fam Physician. 2001, 30 (4): 399-406.PubMed Veitch C, Hollins J, Worley P, Mitchell G: General practice research. Problems and solutions in participant recruitment and retention. Aust Fam Physician. 2001, 30 (4): 399-406.PubMed
16.
go back to reference Williamson MK, Pirkis J, Pfaff JJ, Tyson O, Sim M, Kerse N, Lautenschlager NT, Stocks NP, Almeida OP: Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Med Res Methodol. 2007, 7: 42-10.1186/1471-2288-7-42.CrossRefPubMedPubMedCentral Williamson MK, Pirkis J, Pfaff JJ, Tyson O, Sim M, Kerse N, Lautenschlager NT, Stocks NP, Almeida OP: Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Med Res Methodol. 2007, 7: 42-10.1186/1471-2288-7-42.CrossRefPubMedPubMedCentral
17.
go back to reference Asch S, Connor SE, Hamilton EG, Fox SA: Problems in recruiting community-based physicians for health services research. J Gen Intern Med. 2000, 15 (8): 591-599. 10.1046/j.1525-1497.2000.02329.x.CrossRefPubMedPubMedCentral Asch S, Connor SE, Hamilton EG, Fox SA: Problems in recruiting community-based physicians for health services research. J Gen Intern Med. 2000, 15 (8): 591-599. 10.1046/j.1525-1497.2000.02329.x.CrossRefPubMedPubMedCentral
18.
go back to reference Lancaster GA, Dodd S, Williamson PR: Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004, 10 (2): 307-312. 10.1111/j..2002.384.doc.x.CrossRefPubMed Lancaster GA, Dodd S, Williamson PR: Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004, 10 (2): 307-312. 10.1111/j..2002.384.doc.x.CrossRefPubMed
19.
20.
go back to reference Feeley N, Cossette S, Cote J, Heron M, Stremler R, Martorella G, Purden M: The importance of piloting an RCT intervention. Can J Nurs Res. 2009, 41 (2): 85-99.PubMed Feeley N, Cossette S, Cote J, Heron M, Stremler R, Martorella G, Purden M: The importance of piloting an RCT intervention. Can J Nurs Res. 2009, 41 (2): 85-99.PubMed
21.
go back to reference Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
22.
go back to reference Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ. 2000, 321 (7262): 694-696. 10.1136/bmj.321.7262.694.CrossRefPubMedPubMedCentral Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ. 2000, 321 (7262): 694-696. 10.1136/bmj.321.7262.694.CrossRefPubMedPubMedCentral
23.
go back to reference Graham ID, Tetroe J: Learning from the U.S. Department of Veterans Affairs Quality Enhancement Research Initiative: QUERI Series. Implement Sci. 2009, 4: 13-10.1186/1748-5908-4-13.CrossRefPubMedPubMedCentral Graham ID, Tetroe J: Learning from the U.S. Department of Veterans Affairs Quality Enhancement Research Initiative: QUERI Series. Implement Sci. 2009, 4: 13-10.1186/1748-5908-4-13.CrossRefPubMedPubMedCentral
24.
go back to reference Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM: Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ Res. 2006, 21 (5): 688-694. 10.1093/her/cyl081.CrossRefPubMed Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM: Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ Res. 2006, 21 (5): 688-694. 10.1093/her/cyl081.CrossRefPubMed
27.
go back to reference Becker PT: Publishing pilot intervention studies. Research in Nursing & Health. 2008, 31 (1): 1-3.CrossRef Becker PT: Publishing pilot intervention studies. Research in Nursing & Health. 2008, 31 (1): 1-3.CrossRef
28.
go back to reference Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ: The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009, 37 (1 Suppl): S69-74. 10.1097/CCM.0b013e3181920e33.CrossRefPubMed Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ: The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009, 37 (1 Suppl): S69-74. 10.1097/CCM.0b013e3181920e33.CrossRefPubMed
29.
go back to reference Prescott PA, Soeken KL: The potential uses of pilot work. Nurs Res. 1989, 38 (1): 60-62. 10.1097/00006199-198901000-00015.CrossRefPubMed Prescott PA, Soeken KL: The potential uses of pilot work. Nurs Res. 1989, 38 (1): 60-62. 10.1097/00006199-198901000-00015.CrossRefPubMed
30.
go back to reference Légaré F, Labrecque M, Leblanc A, Thivierge R, Godin G, Laurier C, Cote L, O'Connor AM, Allain-Boule N, Rousseau J: Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial. BMC Fam Pract. 2007, 8: 65-CrossRefPubMedPubMedCentral Légaré F, Labrecque M, Leblanc A, Thivierge R, Godin G, Laurier C, Cote L, O'Connor AM, Allain-Boule N, Rousseau J: Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial. BMC Fam Pract. 2007, 8: 65-CrossRefPubMedPubMedCentral
31.
go back to reference Légaré F, Labrecque M, LeBlanc A, Godin G, Thivierge R, Laurier C, Cote L, O'Connor A: Training of family physicians in shared decision making for the use of antibiotics for acute respiratory infections: a pilot clustered randomized trial. Health Expect. 2010, Légaré F, Labrecque M, LeBlanc A, Godin G, Thivierge R, Laurier C, Cote L, O'Connor A: Training of family physicians in shared decision making for the use of antibiotics for acute respiratory infections: a pilot clustered randomized trial. Health Expect. 2010,
32.
go back to reference Groupe de médecine de famille. Document synthèse. 2002, Santé et services sociaux Québec Groupe de médecine de famille. Document synthèse. 2002, Santé et services sociaux Québec
35.
go back to reference Légaré F, Kearing S, Clay K, O'Connor A: Are you sure? Assessing patient decisional conflict with a 4-item screening test. Canadian family physician. 2009 Légaré F, Kearing S, Clay K, O'Connor A: Are you sure? Assessing patient decisional conflict with a 4-item screening test. Canadian family physician. 2009
36.
37.
go back to reference O'Connor AM, Wells G, Jacobsen MJ, Elmslie T, Tugwell P: Validation of a decision regret scale. October 24, 2001 2001; University of Ottawa, Canada. 2001 O'Connor AM, Wells G, Jacobsen MJ, Elmslie T, Tugwell P: Validation of a decision regret scale. October 24, 2001 2001; University of Ottawa, Canada. 2001
38.
go back to reference Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J: Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009, 339: b2885-10.1136/bmj.b2885.CrossRefPubMedPubMedCentral Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J: Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009, 339: b2885-10.1136/bmj.b2885.CrossRefPubMedPubMedCentral
39.
go back to reference Cals JW, Hood K, Aaftink N, Hopstaken RM, Francis NA, Dinant GJ, Butler CC: Predictors of patient-initiated reconsultation for lower respiratory tract infections in general practice. Br J Gen Pract. 2009, 59 (567): 761-764. 10.3399/bjgp09X472656.CrossRefPubMedPubMedCentral Cals JW, Hood K, Aaftink N, Hopstaken RM, Francis NA, Dinant GJ, Butler CC: Predictors of patient-initiated reconsultation for lower respiratory tract infections in general practice. Br J Gen Pract. 2009, 59 (567): 761-764. 10.3399/bjgp09X472656.CrossRefPubMedPubMedCentral
40.
go back to reference Marinopoulos SS, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, Miller RG, Thomas PA, Prokopowicz GP, Qayyum R: Effectiveness of continuing medical education. Evid Rep Technol Assess (Full Rep). 2007, 1-69. 149 Marinopoulos SS, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, Miller RG, Thomas PA, Prokopowicz GP, Qayyum R: Effectiveness of continuing medical education. Evid Rep Technol Assess (Full Rep). 2007, 1-69. 149
41.
go back to reference Dormandy E, Kavalier F, Logan J, Harris H, Ishmael N, Marteau TM: Maximising recruitment and retention of general practices in clinical trials: a case study. Br J Gen Pract. 2008, 58 (556): 759-766. 10.3399/bjgp08X319666. i-iiCrossRefPubMedPubMedCentral Dormandy E, Kavalier F, Logan J, Harris H, Ishmael N, Marteau TM: Maximising recruitment and retention of general practices in clinical trials: a case study. Br J Gen Pract. 2008, 58 (556): 759-766. 10.3399/bjgp08X319666. i-iiCrossRefPubMedPubMedCentral
42.
go back to reference Harter M, Simon D: Shared decision-making in diverse health care systems--translating research into practice. Patient Educ Couns. 2008, 73 (3): 399-401. 10.1016/j.pec.2008.09.004.CrossRefPubMed Harter M, Simon D: Shared decision-making in diverse health care systems--translating research into practice. Patient Educ Couns. 2008, 73 (3): 399-401. 10.1016/j.pec.2008.09.004.CrossRefPubMed
43.
go back to reference Gardner G, Gardner A, MacLellan L, Osborne S: Reconceptualising the objectives of a pilot study for clinical research. Int J Nurs Stud. 2003, 40 (7): 719-724. 10.1016/S0020-7489(03)00011-7.CrossRefPubMed Gardner G, Gardner A, MacLellan L, Osborne S: Reconceptualising the objectives of a pilot study for clinical research. Int J Nurs Stud. 2003, 40 (7): 719-724. 10.1016/S0020-7489(03)00011-7.CrossRefPubMed
44.
go back to reference Perry SE: Appropriate use of pilot studies. J Nurs Scholarsh. 2001, 33 (2): 107-PubMed Perry SE: Appropriate use of pilot studies. J Nurs Scholarsh. 2001, 33 (2): 107-PubMed
45.
go back to reference Strull WM, Lo B, Charles G: Do patients want to participate in medical decision making?. JAMA. 1984, 252 (21): 2990-2994. 10.1001/jama.252.21.2990.CrossRefPubMed Strull WM, Lo B, Charles G: Do patients want to participate in medical decision making?. JAMA. 1984, 252 (21): 2990-2994. 10.1001/jama.252.21.2990.CrossRefPubMed
Metadata
Title
Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial
Authors
Annie LeBlanc
France Légaré
Michel Labrecque
Gaston Godin
Robert Thivierge
Claudine Laurier
Luc Côté
Annette M O'Connor
Michel Rousseau
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2011
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/1748-5908-6-5

Other articles of this Issue 1/2011

Implementation Science 1/2011 Go to the issue