Analysis and elimination of barriers to the implementation of an early switch of intravenous to oral antibiotic therapy for the treatment of severe community-acquired pneumonia in the Netherlands

Community-acquired pneumonia (CAP) is a highly prevalent disease. The clinical spectrum varies from mild disease that can be managed outside the hospital to severe needing ICU admission or prolonged hospitalisation. Hospital admissions are associated with high healthcare costs which are mainly determined by the length of hospital stay. The main factor that determines the duration of hospitalisation is duration of intravenous antibiotic therapy. Based on literature and available guidelines, an early switch strategy from intravenous to oral antibiotic therapy in severe CAP is proven safe, simple, patient friendly and has the potential to significantly reduce length of hospital stay and the associated health care costs. However, up to now in the Netherlands, it is unknown to what extent this strategy has really been implemented in routine daily practice, what barriers for implementation are and what intervention will help to realize widespread implementation in daily practice in Dutch hospitals. Previous analyses in non-severe CAP have shown that physicians have barriers for early switch to oral therapy. Strikingly, physicians are more reluctant to an early switch to oral therapy if patients have severe presentations of the disease. If potential barriers are known, active and targeted feedback on these barriers might improve adherence to an early switch strategy, which in turn leads to improved cost-effectiveness of the treatment of severe CAP patients. Direct and active feedbacks on actions, reminder systems, disease management guidelines, use of opinion leaders and education have been more or less effective in the past in other disease management processes. In the proposed study, we aim to improve adherence to early switch to oral treatment in severe CAP by means of identification and quantification of the suspected implementation problem, the identification of factors that impose this problem, and an intervention based on the identified barriers by means of active feedback and education. The ultimate goal is to reduce duration of intravenous treatment, duration of hospitalisation and associated costs. We aim to perform a two phase evaluation – implementation clinical trial. Based on previous studies, a “baseline” adherence to switch therapy of about 55 % can be expected. To detect a relevant difference in 20% improvement of adherence with power of 80% and a 95% confidence interval 2 sided, 98 patients need to be included in both phases. The primary outcome measure is the length of intravenous treatment in period 2 as compared to period 1. Secondary outcome measures include length of hospital stay, costs for treatment and the implementation strategy, net cost reduction, number of patients adequately switched to oral therapy, and mortality. Resource use during hospital stay for diagnostic and therapeutic interventions and antibiotic use are recorded using case record forms and extracted from the electronic hospital patient file. In phase one, during the first 6 months, an observation will be performed in 100 consecutive patients admitted because of severe CAP. The study team will evaluate whether clinicians have made the switch to oral therapy when patients have reached clinical stability at day 3 of hospital admission. By means of questionnaires, the treating physician will be asked whether he has made switch to oral treatment, and, if not, what the reasons are and what would have facilitated a switch to oral therapy. This analysis will be performed to identify potential patient related, physician related and organisational barriers, which will be targeted in the second phase of the study. Outcomes are qualitatively formulated in the form of identified obstacles. In addition, relevant patient characteristics, clinical outcome measures and resource use will be prospectively collected using the electronic patient files. In phase 2, an intervention will be carried out in 100 additional consecutive patients. Before starting phase 2, an educational kick-off meeting will be organised, in which current evidence on efficient severe CAP-treatment is discussed and the results of the observational period (phase 1) will be presented. Based on the results of the observational period, the study team actively gives feedback to the treating physicians to important clinical decision points and gives an advice on further treatment, specifically on the switch to oral treatment. The advice will be issued by phone or personally and a flow diagram will be placed in the patient file of the patients with a treatment and management advise. The exact way of feedback however will be dependent of the barriers identified in phase 1. The ultimate goal is to improve the implementation of the save and cost-effective early switch strategy in clinical practice, gain experience with education of physicians by means of active feedback and to shorten hospital stay for patients admitted because of severe CAP.