Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials

BMC Medical Research Methodology

Tim Usherwood¹  Helen K Reddel³  Lorraine Smith⁴  Susan M Sawyer²  Juliet M Foster³ 

[1] Department of General Practice Sydney Medical School Westmead, University of Sydney, Sydney, Australia;Murdoch Childrens Research Institute, Melbourne, Australia;Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia;Faculty of Pharmacy, University of Sydney, Sydney, Australia

关键词: control;    Asthma/prevention &;    Randomized controlled trials as topic;    Physician-patient relations;    General practitioners;    Patient selection;    Attitude of health personnel;   

Others  :  1143575
DOI  :  10.1186/s12874-015-0012-3

 received in 2014-10-21, accepted in 2015-02-20,  发布年份 2015

【 摘 要 】

Background

Primary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials.

We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice.

Methods

GPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes.

Results

40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team.

Conclusion

Targeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12610000854033 webcite (date registered 14/10/2010).

【 授权许可】

   
2015 Foster et al.; licensee BioMed Central.

【 参考文献 】

• [1]Tunis SR, Stryer DB, Clancy CM: Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003, 290(12):1624-32.
• [2]Hahn DL, Plane MB: Feasibility of a practical clinical trial for asthma conducted in primary care. J Am Board Fam Pract 2004, 17(3):190-5.
• [3]Bower P, Wilson S, Mathers N: Short report: How often do UK primary care trials face recruitment delays? Fam Pract 2007, 24(6):601-3.
• [4]Newington L, Metcalfe A: Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams. BMC Med Res Methodol 2014, 14:10. BioMed Central Full Text
• [5]Ngune I, Jiwa M, Dadich A, Lotriet J, Sriram D: Effective recruitment strategies in primary care research: a systematic review. Qual Prim Care 2012, 20(2):115-23.
• [6]Pearl A, Wright S, Gamble G, Doughty R, Sharpe N: Randomised trials in general practice–a New Zealand experience in recruitment. New Zeal Med J 2003, 116(1186):U681.
• [7]Williamson MK, Pirkis J, Pfaff JJ, Tyson O, Sim M, Kerse N, et al.: Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Med Res Methodol 2007, 7:42. BioMed Central Full Text
• [8]Askew DA, Clavarino AM, Glasziou PP, Del Mar CB: General practice research: attitudes and involvement of Queensland general practitioners. Med J Aust 2002, 177(2):74-7.
• [9]Pringle M, Churchill R: Randomized Controlled Trials in General-Practice - Gold Standard or Fools Gold. Brit Med J 1995, 311(7017):1382-3.
• [10]Brodaty H, Gibson LH, Waine ML, Shell AM, Lilian R, Pond CD: Research in general practice: a survey of incentives and disincentives for research participation. Ment Health Fam Med 2013, 10(3):163-73.
• [11]Bell-Syer SE, Moffett JA: Recruiting patients to randomized trials in primary care: principles and case study. Fam Pract 2000, 17(2):187-91.
• [12]Ewing G, Rogers M, Barclay S, Mccabe J, Martin A, Todd C: Recruiting patients into a primary care based study of palliative care: why is it so difficult? Palliative Med 2004, 18(5):452-9.
• [13]Hetherton J, Matheson A, Robson M: Recruitment by GPs during consultations in a primary care randomized controlled trial comparing computerized psychological therapy with clinical psychology and routine GP care: problems and possible solutions. Prim Health Care Res Dev 2004, 5:5-10.
• [14]Mason VL, Shaw A, Wiles NJ, Mulligan J, Peters TJ, Sharp D, et al.: GPs’ experiences of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract 2007, 24(5):518-25.
• [15]Foy R, Parry J, Duggan A, Delaney B, Wilson S, Lewin-van den Broek N, et al.: How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Fam Pract 2003, 20(1):83-92.
• [16]Eldridge SM, Ashby D, Feder GS: Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care. Clin Trials 2005, 2(2):91-8.
• [17]Page MJ, French SD, McKenzie JE, O’Connor DA, Green SE: Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners’ recruitment of patients. BMC Med Res Methodol 2011, 11:35. BioMed Central Full Text
• [18]Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, et al.: Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol 2014, 134(6):1260-8.
• [19]Foster JM, Smith L, Usherwood T, Sawyer SM, Rand CS, Reddel HK: The reliability and patient acceptability of the SmartTrack device: a new electronic monitor and reminder device for metered dose inhalers. J Asthma 2012, 49(6):657-62.
• [20]Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, et al.: Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol 2006, 117(3):549-56.
• [21]Goeman DP, Hogan CD, Aroni RA, Abramson MJ, Sawyer SM, Stewart K, et al.: Barriers to delivering asthma care: a qualitative study of general practitioners. Med J Aust 2005, 183(9):457-60.
• [22]PROSPeR. An analytical framework for planning and sustaining recruitment to research studies in primary care based on evidence from the literature. [http://webarchive.nationalarchives.gov.uk/20100218141456/nspcr.ac.uk/publications/prosper2.pdf]
• [23]Watson JM, Torgerson DJ: Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 2006, 6:34. BioMed Central Full Text
• [24]Reed RL, Barton CA, Isherwood LM, Baxter JM, Roeger L: Recruitment for a clinical trial of chronic disease self-management for older adults with multimorbidity: a successful approach within general practice. BMC Fam Pract 2013, 14:125. BioMed Central Full Text
• [25]General Practice Statistics. [www.health.gov.au/internet/main/publishing.nsf/Content/General+Practice+Statistics-1]
• [26]Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S: Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ open 2012, 2(1):e000496.
• [27]French SD, McKenzie JE, O’Connor DA, Grimshaw JM, Mortimer D, Francis JJ, et al.: Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial. PLoS One 2013, 8(6):e65471.
• [28]Peto V, Coulter A, Bond A: Factors affecting general practitioners’ recruitment of patients into a prospective study. Fam Pract 1993, 10(2):207-11.
• [29]Shah S, Roydhouse JK, Toelle BG, Mellis CM, Jenkins CR, Edwards P, et al.: Recruiting and retaining general practitioners to a primary care asthma-intervention study in Australia. Aust J Prim Health 2014, 20(1):98-102.
• [30]Jones KM, Dixon ME, Falkingham L, Piteman L, Dixon JB: Barriers to recruitment of professionals into a general practice childhood obesity program. Aust J Prim Health 2011, 17(2):156-61.
• [31]Rothwell PM: Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials 2006, 1(1):e9.
• [32]Royal College of General Practitioners: Research Ready Self Accreditation. [http://www.rcgp.org.uk/clinical-and-research/research-opportunities-and-awards/research-ready-self-accreditation.aspx]