Qualitative interviews with HCP participants identified a number of factors that could act as barriers to or facilitators of the implementation of trial processes.
It was clear that initial knowledge of associations between alcohol consumption and surgical outcomes was limited and that knowledge of the potential benefits of the research predominantly derived from the training provided. Without this understanding, it is unlikely that HCPs would volunteer to participate in the trial. Having the required time to complete trial activities, including screening, intervention, co-ordination and follow-up, was important as PACs were considered to be busy and individual appointments included a relatively extensive assessment. Having adequate staff time allocated for intervention delivery was considered vital to the effective delivery of intervention sessions but could present a problem if patients failed to attend or declined to participate on the day. Furthermore, HCPs based in PACs often struggled to balance research tasks against PA roles. In addition to having the necessary training to deliver screening and intervention,
gaining‘real-life’ experience of delivery and becoming familiar with the tools were highlighted as important
through training or role-play activities but required experience with actual patients and within the day-to-day clinic. The application of NPT allowed further identification of issues specifically related to the implementation of trial activities. These included limited higher-level management support for trial activities, infrequent intervention delivery and limited visibility of the research within the PAC.
Chapter 6 Conclusions and recommendations
Conclusions
This work finds that preoperative alcohol screening using the AUDIT-C and full AUDIT is acceptable to patients and HCPs. Similarly, delivering BBI in the PAC is possible and the intervention methods adopted were acceptable to patients and HCPs. The evidence supports the feasibility of a definitive trial to assess the effectiveness of these methods in bringing about reductions in preoperative alcohol consumption and secondary outcomes of surgical complications if recommendations to enhance recruitment are adopted.
Recommendations
The primary recommendation from this project is that a definitive RCT is feasible. The very high levels of retention in the pilot RCT and data completion at baseline and follow-up mitigate the fact that recruitment fell slightly short of the initial target. With the background literature identifying a wealth of evidence on the associations between preoperative alcohol consumption and surgical outcomes, but a sparsity of evidence regarding the effectiveness of behavioural interventions in reducing preoperative alcohol consumption, such a definitive trial is also considered to be appropriate.
A number of secondary recommendations for the design and conduct of a definitive trial can also be made. These are arranged in priority order.
1. Evidence from both the feasibility study and the pilot RCT shows that avoiding potentially pejorative terminology in any recruitment materials and the adoption of a non-judgemental approach throughout are vital for recruitment to be successful. Specifically, a future trial should:
– avoid any categorisation of drinking as ‘risky’, ‘harmful’ or ‘hazardous’ – communicate that all patients are being invited to complete screening.
2. Qualitative evidence shows limited understanding of, and low familiarity with, the term‘standard drink’;
it is therefore recommended that:
– the term ‘units’ be adopted in all trial materials
– HCPs be trained and prepared to ensure that they are confident in converting patient descriptions of alcohol consumed in terms of pints or glasses into units in order to enhance the accuracy
of screening
– interventions include a description of units to enhance interpretation of the lower-risk drinking guidelines and increase the accurate monitoring of alcohol.
3. Although qualitative evidence from trial participants identified that the burden of participation was acceptable, the rate of eligible participants (34%) consented may be further improved by streamlining the trial visits. Specifically:
– with the very low delivery of the optional booster session, this visit should be excluded from any future trials
– with low completion rates of visit 3 (1–3 days pre surgery), this visit could be scheduled to take place when patients arrive at the hospital on the day of surgery.
– with variable length of stay and some difficulties completing the WOMAC questionnaire at visit 4
(in-hospital follow-up 3–5 days post surgery), a future trial should consider either conducting this
visit 1–3 days post surgery or amending it to focus only on postoperative complications that can be
collected from patient notes
– as in this pilot RCT, all study visits should be arranged to either take place around existing hospital
appointments or be conducted over the telephone or at the patients’ home in order to minimise
burden and remove any requirement for additional travel to the hospital site.
4. With 40% of eligible patients who declined participation in the trial stating that they did so because
they were‘not interested’, future trials should ensure that the initial approach and introduction to the
study is appealing and clearly sets out potential health benefits of participation.
5. With HCP interviews identifying difficulties in balancing research roles with clinical demands in busy PACs, it is recommended that future trials:
– arrange for all follow-ups to be conducted by research-specific staff while PA staff maintain the role of intervention delivery
– work with PA leads throughout the trial to raise the profile of the research in the clinic, track progress against targets and identify any issues.
6. With evidence from the focus groups and HCP survey showing that PA frequently involves the assessment of alcohol consumption and may include a brief recommendation to reduce drinking prior to surgery alongside qualitative evidence that some participants in both the feasibility study and pilot trial report reducing their alcohol consumption following initial screening and invitation to participate, future trials should:
– assess eligibility in terms of alcohol consumption based on initial screening – carefully consider and characterise the comparator condition.
Acknowledgements
T
he PRE-OP BIRDS research team would like to acknowledge the contribution of all HCP and patientparticipants; the PA leads from the three recruiting centres, Emma McCone, Hilary Turner and Munyaradzi Vushemasimba; Elaine Stamp and Lesley Hall for their work on the feasibility study; Sebastian Potthoff for his work on the HCP training; and all members of the TSC and Data Monitoring Committee.