1. 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

2. Acknowledgements
Health Research Board of Ireland funded the study (2012 Grant ID: HRA-HSR )
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

3. 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………

4. 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

5. 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)

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

7. 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

8. 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):
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

9. 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)

10. 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

11. 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

12. 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
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: /s
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)