Deploying a clinical innovation in the context of actor-patient consultations in general practice: A prelude to a formal clinical trial

Background: Innovations to be deployed during consultations with patients may influence the clinical performance of the medical practitioner. This study examined the impact on General Practitioners' (GPs) consultation performance of novel computer software, designed for use while consulting the patient. Methods: Six GPs were video recorded consulting six actor-patients in a simulated clinical environment. Two sessions were recorded with six consultations per GP. Five cases presented cancer symptoms which warranted a referral for specialist investigation. Practitioners were invited to use a novel software package to process referrals made during the consultations in the second session. Two assessors independently reviewed the consultation performance using the Leicester Assessment Package (LAP). Inter-rater agreement was assessed by a Bland-Altman plot of the difference in score against the average score. Results: Sixty of the seventy two consultations were successfully recorded. Each video consultation was scored twice by two assessors leaving 120 LAP scores available for analysis. There was no evidence of a difference in the variance with increasing score (Pitmans test p = 0.09). There was also no difference in the mean differences between assessor scores whether using the software or not (T-test, P = 0.49) Conclusion: The actor-patient consultation can be used to test clinical innovations as a prelude to a formal clinical trial. However the logistics of the study may impact on the validity of the results and need careful planning. Ideally innovations should be tested within the context of a laboratory designed for the purpose, incorporating a pool of practitioners whose competencies have been established and assessors who can be blinded to the aims of the study.