The goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects CAP, who have FLUS performed as an addition to usual care, have antibiotics prescribed less frequent compared to those given usual care only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
391
We will use a 14-zone scanning approach. Each hemithorax is divided into anterior, lateral, and posterior surfaces. The anterior and lateral surfaces on each hemithorax are divided into an upper and lower quadrant. The posterior surfaces on each hemithorax are divided into an upper, middle, and lower quadrant. Each quadrant represents a scanning zone. Each scanning zone should be assessed using FLUS. The participating general practitioners use point-of-care ultrasound on a weekly basis before trial commencement and will use the ultrasonography device already available to them.
Participants assigned to the control group will receive the GP's usual care of adults (≥ 18 years) presenting with symptoms of an acute LRTI where the GP suspects CAP. Usual care will be used as a pragmatic comparator to reflect the current standard examinations and care of these patients in general practices in Denmark. Usual care is recommended to follow applicable guidelines from the Danish Society of General Practitioners (DSAM) and Lægehåndbogen \[The Doctor's Handbook\].
Center for General Practice at Aalborg University
Gistrup, Denmark
Antibiotics prescribed at index consultation
The primary outcome is the proportion of participants with antibiotics prescribed at index consultation (day 0) reported by the GP at index consultation. We will assess the effect of adding FLUS to usual care on antibiotics prescribed at index consultation by investigating if there is a difference between groups in the proportion of participants with antibiotics prescribed at index consultation..
Time frame: Day 0
Daily total LRTI symptom-score
Daily total LRTI symptom-score in groups, calculated as sum of scores of six symptoms (minimum 0 - maximum 36) (mean/median). Participants will be asked to complete a validated LRTI symptom diary every day from day 0 up until day 21. The recorded items include the following six symptoms of LRTI: cough, dyspnea, sputum production, well-being, sleep disturbance, and activity disturbance. The participants will be asked to consider how bad each symptom has been, over the past 24 hours by scoring each symptom on a 7-point Likert-scale (0 = no problem, 1 = very little problem, 2 = slight problem, 3 = moderate problem, 4 = bad problem, 5 = very bad problem, and 6 = as bad as it could be).
Time frame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days with symptoms being a "moderate problem" or worse
Number of days with symptoms rated a "moderate problem" or worse by the participants in groups (at least one item with score 3 or above) (mean/median).
Time frame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days signed in sick/cancelled work-related activities
Number of days participants signed in sick/cancelled work-related activities or cancelled leisure activities (mean/median) in groups.
Time frame: From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
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Satisfaction with the index consultation
Proportion of participants satisfied or very satisfied (4 or 5) with the index consultation on a 5-point Likert scale.
Time frame: Day 0
Antibiotics prescribed as delayed antibiotic prescription
Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).
Time frame: Day 0
Antibiotics prescribed during follow-up
Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.
Time frame: Up until day 28
Re-consultations
Proportion of participants with re-consultations, defined as any primary care contacts (general practice or out-of-hour services), within 28 days after index consultation.
Time frame: Up until day 28.
Admission to hospital
Proportion of participants admitted to hospital within 28 days after index consultation.
Time frame: Up until day 28.
Complications
Proportion of participants with complications (pleural infection (defined as complicated parapneumonic effusion or empyema), lung abscess, or sepsis) during admission to hospital within 28 days after index consultation.
Time frame: Up until day 28.
Other imaging than FLUS performed
Proportion of participants with other imaging than FLUS (any imaging performed in secondary health care services) performed within 28 days after index consultation.
Time frame: Up until day 28.
Types of other imaging performed
Types of other imaging than FLUS performed within 28 days after index consultation.
Time frame: Up until day 28.
Referred with suspicion of cancer
Proportion of participants referred with suspicion of cancer within 60 days after index consultation.
Time frame: Up until day 60.
Diagnoses of cancer
Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.
Time frame: Up until day 60.
Spontaneously reported unintended events
Number of spontaneously reported unintended events up until 60 days after index consultation.
Time frame: Up until day 60.
Mortality
All-cause mortality up until day 28 and day 60.
Time frame: Up until day 28 and 60.