JMIR Publications

ABSTRACT

Background:

Acute respiratory infections (ARIs) are frequent reasons for medical consultations in general practice. Point-of-care (POC) diagnostic equipment may support an attractive and efficient handling of these contacts including provision of a more precise and exact microbial diagnosis. However, several contextual factors may impact such implementation.

Objective:

To evaluate the effect of POC PCR test availability in general practice on subsequent 1) number of re-contacts for patients with symptoms of ARIs (primary outcome), and 2) hospital admissions, 3) deaths, 4) antibiotic prescriptions, 5) as well as health-related quality-of-life (HQoL), 6) general practitioner (GP) and patient satisfaction, 7) costs, and 8) cost-effectiveness as secondary outcomes. Furthermore, we aimed to identify and analyze contextual factors that influenced the implementation process.

Methods:

This study is a cluster-randomized crossover, non-blinded superiority trial with a 1:1 allocation ratio between usual care (control) and POC PCR test availability (intervention). The unit of randomization was GP clinic. The trial consisted of two periods of seven weeks (intervention and control) during the peak season of ARI in Denmark. During both periods, all patients with ARI symptoms were registered consecutively. During the intervention period, the GPs had free access to a POC PCR device with an option to test ARI patients for group A streptococcus, severe acute respiratory syndrome coronavirus 2, influenza, and respiratory syncytial virus. Questionnaire data was collected at day 0, day 7, 14, and day 28 after the initial contact (HQoL, absenteeism and presentism among patients, patient satisfaction) and after finalization of the study period (GP satisfaction). Data on re-contacts, hospital admissions, redeemed antibiotic prescriptions, costs and deaths will be retrieved from the Danish national registries. The implementation process will be evaluated based on data from interviews with users of POC PCR tests (GPs, staff, and patients) and from observations in the GP clinics.

Results:

None

Conclusions:

POC PCR technology is not yet available to Danish general practice. In this study, the effects of introducing POC PCR for diagnosing ARI is explored, measuring clinical, economical, and organizational aspects of the use of POC PCR in general practice and exploring behavioral, organizational, and communicative factors that emerge during – and which may affect – implementation processes. This study will thus provide valuable information about the diagnostic conditions and possibilities in general practice as well as the organization of primary health care. Clinical Trial: The study is approved by University of Southern Denmark’s Research & Innovation Organisation (SDU RIO) (journal number: 11.907) and The Research Ethics Committee (Case no. 23/1584). Further the study is registered at ClinicalTrials.gov (ID number: NCT06120153)