Evaluating the Effect of a Molecular Point-of-Care Test on Acute Respiratory Infections in General Practice: Protocol for a Cluster Randomized Trial (Preprint)

<sec> <title>BACKGROUND</title> Acute respiratory infections (ARIs) are frequent reasons for medical consultations in general practice and can lead to unnecessary recontacts. Introducing new point-of-care (POC) polymerase chain reaction (PCR) diagnostic equipment may offer an attractive and efficient way of providing a more precise and exact microbial diagnosis. Successful uptake of POC PCR equipment could potentially lead to a reduction in recontacts with benefits for both staff and patients. However, introducing new diagnostic technology is a complex intervention and several contextual factors may impact the implementation. </sec> <sec> <title>OBJECTIVE</title> This study aims to evaluate the effect of POC PCR test availability in general practice on the subsequent (1) number of recontacts to the general practitioner (GP) for patients with symptoms of ARIs (primary outcome) and (2) hospital admissions, deaths, antibiotic prescriptions, health-related quality of life, GP and patient satisfaction, costs, cost-effectiveness, and contextual facilitators and barriers conditioning the implementation process (secondary outcomes). </sec> <sec> <title>METHODS</title> This study is a cluster-randomized, crossover, nonblinded superiority trial with a 1:1 allocation ratio between usual care (control) and POC PCR test availability (intervention). Questionnaire data are collected at day 0, 7, 14, and 28 after the initial contact (health-related quality of life, absenteeism and presentism among patients, and patient satisfaction) and after finalization of the study period (GP satisfaction). Data on recontacts, 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 (i.e., GPs, staff, and patients) and from observations in the clinics in line with Medical Research Council guidelines. </sec> <sec> <title>RESULTS</title> As per the randomized crossover design carried out during September 2023 to March 2024 investigating a sample of 100 GP clinics, we expect to obtain an in-depth and multifaceted understanding of the effects of the availability of the POC PCR test equipment in general practice. </sec> <sec> <title>CONCLUSIONS</title> This study will provide valuable information about the diagnostic conditions and possibilities in general practice and provide insights into the organization of primary health care. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT06120153; https://clinicaltrials.gov/study/NCT06120153 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/72842 </sec>