Observation/procedure | Timings of visit/contact | |||||||
---|---|---|---|---|---|---|---|---|
Person undertaking the specified event | Screening/registration Days 0–1 | Treatment Week 1 Days 1–7 | Treatment Week 2 Days 8–14 | Follow-up Week 3 Days 15–21 | Follow-up Week 4 Days 22–28 | Follow-up Week 5 Day 35 | End of study Week 12 Day 84 | |
Informed consent | GP/nurse1/HCA1/RA1 | X | ||||||
Eligibility evaluation | GP/nurse prescriber1 | X | ||||||
Relevant medical history | GP/nurse/HCA | X | ||||||
Assess AECOPD symptoms | GP/nurse/HCA | X | ||||||
Prescribe antibiotics (as appropriate) | GP/nurse prescriber | X | ||||||
Issue trial medication/randomisation | GP/nurse/HCA/RA | X | ||||||
Issue treatment/symptom questionnaire diary | GP/nurse/HCA/RA | X | ||||||
Vital Signs | GP/nurse/HCA | X9 | ||||||
Completion of CATTM symptom questionnaire3 | GP/nurse/HCA/RA/patient3 | X3,9 | X3 | X3 | X3 | |||
Demographic data* | Patient | X | ||||||
Completion of EXACT-PRO® symptom questionnaire2 | Patient | X | X | (X)2 | (X)2 | |||
Completion of treatment diary | Patient | X | X | X | X | |||
Phone call to patient (questionnaire assessment)4 | SCTU | X4 | X4 | X4 | X | |||
Completion of diary/questionnaire by recall5 | SCTU and patient | X | X | |||||
Adverse event (AE) notification6 | SCTU and patient | X | X | X | ||||
AE assessing6 | GP | X | X | X | ||||
AE recording/reporting6 | GP/nurse/HCA | X | X | X | ||||
Concomitant medication (only to be recorded in the event of an SAE and specified AEs)7 | GP/nurse/HCA | X | X | X | ||||
Serious adverse event (SAE) assessing | GP | X | X | X | ||||
SAE reporting | GP/nurse/HCA | X | X | X | ||||
Medical notes review | GP/nurse/HCA | X | ||||||
Qualitative interview (refuse to participate in the trial)8 | Qualitative researcher | (X)8 | ||||||
Qualitative interview (participated in the trial) | Qualitative researcher | X10 |