Methodological Challenges Conducting Trials in Primary Care: Lessons Learned from a Feasibility Study of a Complex Intervention to Enhance Alcohol Screening and Brief Intervention Geoff McCombe, Anne Marie Henihan, Jan Klimas, Davina Swan, Dorothy Leahy, David Meagher, Clodagh O’Gorman, Gillian W. Shorter, John S. Lambert, Walter Cullen SSA 2016 Reflect on the Meth challenges we encountered in a before and after feasibility trial in PC of a complex intervention to Enhance Alcohol Screening and BI …which was a collaboration between UCD UL …funded by HRB Funded by a Health Research Award from the Health Research Board of Ireland

Acknowledgements Health Research Board of Ireland funded the study (2012 Grant ID: HRA-HSR-2012-14) Hepcare Europe: funded work by JSL, GMC, WC on the project Project Steering Group: Rory Keane, Rolande Anderson, Thomas P. O’Toole, Margaret Bourke, Jean Saunders, Hellen Kelly, Gerard Bury, Eamon Keenan, David Meagher, Colum Dunne, John S. Lambert, Clodagh O'Gorman, Brian Murphy, Bobby Smyth

Background General practitioners play a vital role in the care of patients with mental and substance use disorders Clinical trials in general practice impacted by methodological challenges: Recruitment Randomisation Intervention fidelity Retention Data quality This is especially the case in trials that involve at risk and vulnerable patient groups GPs vital role –optimally placed in the community to deal with the complexities of issues that these cohorts encounter – and lots of data that can inform care/treatment models But…..carrying out research with GPs brings many challenges………

Aims and Methods Aims: To reflect on methodological challenges experienced in a feasibility study of a complex intervention to enhance alcohol screening and brief intervention (SBI) among problem drug users and explore how these may be addressed in future research Methods: We describe a case study - a pre-and-post feasibility study of a complex intervention to promote alcohol SBI among methadone patients, examine the key challenges encountered and how these may be addressed

The Psychosocial Interventions for Problem Alcohol Use (PINTA) study GP Recruitment GPs in study area (n = 149) GPs agreed to participate (n = 19) GPs recruited (n = 16) Patient Recruitment and Baseline Data Collection Patient sample size: (n = 160) Patients consented: (n = 129) Baseline data: (n = 106) Aim to recruit 16 practices which would recruit 10 patients each Retention and Follow Up GP follow up (n = 13) Patients follow up (n = 81) Intervention (n = 34) Control (n = 47)

Key Challenges Practice recruitment Patient retention Utility of clinical data for research purposes

GP Recruitment Rates The challenges we encountered are common place within general practice research* Time GP burn out Lack of staff support Socio-economically disadvantaged areas ‘Free GP care’ scheme for children under six years of age * Williamson M, Pirkis J, Pfaff J, et al. Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Medical Research Methodology 2007;7(1):42. Disadvantaged areas – Tudor Harts inverse care law that provision of healthcare in inversely correlated to the need

Patient Recruitment and Data Collection High attrition rate for patients - may reflect high rates of chronic disease and multi-morbidity associated among people receiving opioid agonist treatment* Difficulties in contacting patients in a prompt and timely manner as patients changed numbers, screened calls or prematurely terminated telephone conversations Data abstraction from clinical records - a lack of concordance between patient interviews and clinical records due to poor / limited record keeping by general practitioners *O'Toole J, Hambly R, Cox AM, et al. Methadone-maintained patients in primary care have higher rates of chronic disease and multimorbidity, and use health services more intensively than matched controls. The European Journal of General Practice 2014;20(4):275-80. High attrition rates- chronic disease, chaotic lifestyles (though more stable at GP) Pragmatic reasons used telephone for survey Varied nature of the quality of clinical records

Lessons learned Challenge Solution Maximise practice recruitment and participation Visit promptly following acceptance of GP to the study to maintain relationship with recruited GP (Sellors et al. 2002) On-site research personnel (Morden et al. 2015) Develop and implement a research awareness programme encouraging the participation of GPs in research activities (Kersnik et al. 2015) Maximise patient recruitment and retention Employ recruitment strategies that focus on increasing potential participants’ awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process (Caldwell et al. 2010) Provide support to practices during the recruitment process to achieve the recruitment target and throughout the study (Leathem et al. 2009)

Future Recommendation Lessons learned Challenge Future Recommendation Optimise data collection Conduct patient interviews face to face to build rapport with patients and to carry out data collection in a timely and efficient manner On-site researchers to ensure continuing engagement with research endeavour Ensure baseline / follow up data can be collected from clinical records The Intervention   Should be flexible to allow busy practices to engage Benefits for patient care should be apparent Should involve evidence based resource materials, web-based educational resources Engage with practices on how to incorporate into practice

Conclusions Methodological challenges are a problem in the conduct of trials involving people receiving opioid agonist treatment in primary care We have highlighted strategies which researchers may consider when designing intervention studies among patients with mental and substance use disorders in general practice

Thank you for listening… email: geoff.mccombe@ucd.ie Klimas, J., Anderson, R., Bourke, M., Bury, G., Field, C.A., Kaner, E., Keane, R., Keenan, E., Meagher, D., Murphy, B. and O'Gorman, C.S., (2013). Psychosocial Interventions for Alcohol Use Among Problem Drug Users: Protocol for a Feasibility Study in Primary Care. JMIR research protocols, 2(2). Klimas, J., Henihan, A., McCombe, G., Swan, D., Anderson, R., Bury, G., Dunne, C., Keenan, E., Saunders, J., Shorter, G.W. and Smyth, B.P., (2015). Psychosocial interventions for problem alcohol use in primary care settings (PINTA): baseline feasibility data. Journal of dual diagnosis, Vol. 11(2), pp.97-106. Henihan, A.M., McCombe, G., Klimas, J., Swan, D., Anderson, R., Bury, G., Dunne, C., Keenan, E., Lambert, J., Meagher, D., O’Gorman, C., O'Toole, T., Saunders, J., Smyth, B.P., Shorter, G., Kaner, E., Cullen, W. (2016) Feasibility of Alcohol Screening among Patients receiving Opioid Treatment in Primary Care. BMC Family Practice. DOI: 10.1186/s12875-016-0548-2 McCombe, G., Henihan, A.M., Klimas, J., Swan, D., Leahy, D., Anderson, R., Bury, G., Dunne, C., Keenan, E., Lambert, J., Meagher, D., O’Gorman, C., O'Toole, T., Saunders, J., Smyth, B.P., Kaner, E., Cullen, W., (2016). Enhancing alcohol screening and brief intervention among people receiving opioid agonist treatment: qualitative study in primary care. Drugs and Alcohol Today, 16(4)