The Baseline Visit

If a patient contacts the surgery indicating they are experiencing an exacerbation of their COPD, which has been ongoing for at least 24 hours and no longer than 21 days, and express an interest in taking part in the PACE study, they should be invited to make an appointment to attend the surgery for the Baseline Visit.  At this visit, the eligibility of the patient should be confirmed, their informed consent should be taken and the baseline CRF completed.

Eligibility

The doctor or nurse responsible for managing the patient's current illness should complete the eligibility assessment CRF for all patients, to ensure that they are eligible for the study.  Both eligible and ineligible participants should be recorded on the Screening Log.

Consent

The patient will need to provide their written informed consent to participate in the study. Allow them sufficient time to read the patient information sheet and/or go through it with the patient to answer any queries.  Please ensure that a consent form is completed and all boxes are INITALLED by the patient. The consent will also need to be signed and dated by the clinician/nurse taking consent and the patient themselves. Please see your study manual for guidance on taking informed consent.

Baseline Measures

Once eligibility has been confirmed and informed consent given by the participant, the clinician/nurse will need to complete the Baseline Assessment CRF03.

Throat swabs and sputum samples (see study manual for procedures on how to take samples) will need to be taken from the patient and sent to the microbiology laboratory (SACU) in the pre-paid envelopes provided. Before the sputum sample can be sent off to SACU the clinician will need to record the colour of the sample according to the Bronko test. This can be done by looking at the sticker inside the CRF to rate the colour from 1 to 5. Please ensure these samples are taken before the patient is randomised (see Randomisation procedure). Ensure also that the patient completes the CCQ and EQ 5D questionnaires prior to randomisation.

For patients randomised to the CRP point of care arm, the CRP level needs to be recorded in the CRF. For patients randomised to the control arm, a CRP test should not be carried out.

For both arms of the trial the clinician will then need to record their management of the exacerbation (see section: Treatment). They will need to record if they:

  • have had any antibiotics or oral corticosteroids prescribed today
  • have any current inhaled medications been increased or any new inhaled medications been prescribed today.

The CRF should then be signed and dated by the clinician.

Ensure that the participant has received their participant pack which should include a participant booklet, a Week 1 Clinical COPD Questionnaire (CCQ), a Week 1 EQ-5D, and a Week 2 CCQ and Week 2 EQ-5D. Please take a moment to explain the participant booklet to the patient: they should record the medication that they have actually TAKEN (rather than medication they have been prescribed and not taken).

Please also provide the patient with a pot so that they can bring in a sputum sample at their Week 4 follow up visit.

The Contact Form, CRF02, will be completed and the best number and time to contact the participant will be recorded. The Contact Form should be FAXED to the study research centre with the Consent Form as soon as possible

Where possible, a 4 week follow up visit should be booked before the participant leaves the practice. If this is not possible at this baseline visit, please ensure you book the patient in for their 4 week appointment as soon as is possible.