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Table 2 Schedule of observations and procedures

From: Treating Acute EXacerbations of COPD with Chinese HerbAL MedIcine to aid AntiBiotic Use Reduction (EXCALIBUR): study protocol of a randomised double-blind, placebo-controlled feasibility trial

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

 
  1. NR nurse researcher, HCA healthcare assistant, RA research assistant
  2. *The relevant demographic and other data to be recorded by the patient on the first day of treatment are as follows: gender, employment, ethnicity, and smoking history
  3. 1In line with local GP surgery procedures with demonstrable and appropriate level of training. Specific duties delegated by the PI
  4. 2The EXACT-PRO® symptom questionnaire should be completed daily from day 1 of treatment until either the 14 day treatment is complete and resolution of their AECOPD symptoms have been maintained for 7 days or 28 days post-randomisation
  5. 3The CATTM symptom questionnaire should be completed by the patient with the site team staff on day 1 and by the patient in the patient diary on days 14, 28, and 84
  6. 4Patient phone calls to be completed on days 3, 14, and 28 to ensure the diary instructions provided by the research team at baseline are being followed and to answer any questions the patient has regarding diary completion. The SCTU team follow a trial script to ensure the requirements for collecting data for each endpoint are understood by the patient
  7. 5Only to be completed if the participant has not returned their participant diary
  8. 6Only AEs believed related to the trial medication will be recorded on the trial. Reporting and recording of all AEs related to the trial medication is carried out by GP/nurse
  9. 7Concomitant medication should only be recorded in the event of a serious adverse event or an adverse event related to the trial medication. When an SAE or trial medication-related AE occurs, all concomitant medication that the patient was taking at onset of the event should be recorded in the eCRF
  10. 8This interview may take place at any time between confirmation of a patient’s refusal to enter the trial and the end of the trial
  11. 9Vital signs and baseline CAT questionnaire may be completed on day 0 or 1, depending day of provision of patient pack to patient
  12. 10Qualitative interviews will take place at any time from day 35 onwards
  13. NB: The participant is free to withdraw consent at any time without providing a reason. When withdrawn, the participant will continue to receive standard clinical care. Follow-up data will continue to be collected (unless the participant has specifically stated that they do not want this to happen).