Background: Respiratory tract infections (RTIs) are frequent reasons for medical
consultations and diagnostic accuracy is important to ensure appropriate treatment. It is
important for the quality of the healthcare system that patients are diagnosed as fast as
possible and that the GP and the patient are reassured about the diagnostic accuracy. If not,
the patient may be unnecessarily concerned and contact health services again.
Re-contacts are costly for society, but they may also be unsatisfactory to the patient and
the clinician, because many re-contacts may indicate that tentative diagnosis or treatment
were not successful and that in some cases the patient needs to contact health services again
to get a sufficient answer or to be reassured that nothing is dangerous.
The introduction of POC PCR in primary care settings has demonstrated significant
improvements in appropriate antibiotic prescription patterns in high income countries. In
Denmark around 88 pct. of all prescription drugs are issued by general practice, as is the
vast majority of the total antibiotics consumption in the healthcare system.
Antibiotic overuse may lead to microbial resistance and if the overall consumption is not
reduced, infections with resistant bacteria will be a major problem for both patients and
healthcare systems. Due to diagnostic uncertainty, GPs may in some situations prescribe
antibiotics also in cases where the patient's symptoms are caused by a viral infection.
Further, if antibiotics are not prescribed, the patient may reconsult their GP or the
out-of-hours services due to feelings of uncertainty.
Aims: The aim of the study is to evaluate the effect of POC PCR availability in general
practice on 1) the number of re-contacts for patients with symptoms of RTIs, 2) the number of
hospital admission, 3) deaths, 4) the number of redeemed antibiotic prescriptions, 5) costs,
6) health-related quality-of-life, 7) cost-effectiveness compared to usual care and 8) GP
satisfaction.
Furthermore, a qualitative process evaluation will be conducted throughout the trial.
Methods This study is a cluster-randomized crossover, non-blinded superiority trial with a
1:1 allocation ratio. The procedure for randomization takes outset in the clinics'
identification numbers as units. The trial consists of two periods of seven weeks
(intervention and control). Care-as-usual is used as a comparator. The study is approved by
the local regional ethics committee.
The effectiveness study and the cost-effectiveness study will be based on questionnaire data
and data from the unique Danish national registries. Information from the different registers
will be linked by the patients' Danish Personal Identification Number. Outcomes based on
questionnaire data will be collected at baseline, day 7, 14 and day 28 after the initial
visit.
GP and patient recruitment:
General practices in 4 out of 5 Danish regions have been invited to participate. GPs have
been invited through a written letter and regional newsletters sent to all GPs in Denmark in
March 2023. The GPs has been assigned at random to start as intervention or control practice.
Based on sample size calculation, the goal was to include 100 GP clinics.
Each practice is asked to register all patients with symptoms of respiratory tract infections
consecutively. The GPs are informed that it is entirely up to them and their clinical
judgement to make a decision about whether or not they deem it relevant to employ the POC
PCR-test device in the consultation with the patient.