Skip to main content

Table 1 Schedule of enrolment, interventions and assessments for the clinical trial

From: Effectiveness and cost-effectiveness of Improving clinicians’ diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial

Time point

Study period

November 4, 2019–April 30, 2021

Day 1

Week 2

Week 6

Enrolment

 Medical history and physical examination

X

  

 Explanation of the study and informed consent

X

  

 Initial CRF

X

  

 Giving out of the symptom diary, up to week 2

X

  

Interventions

 CRP rapid test if needed (only among those patients visited by professionals assigned to the CRP intervention groups)*

X

  

 Use of an interactive booklet (only among those patients visited by professionals assigned to the enhanced communication skill intervention groups)*

X

  

Assessments

 Assessment of the clinical outcome

 

X

X

 Collection and review of the symptom diary

 

X

 

 EQ-5D-5L questionnaire

X

X

X

 Antibiotic consumption

X

X

X

 Use of drugs other than antibiotics

X

X

X

 Tests ordered by clinicians

X

X

X

 Patient satisfaction with care

 

X

X

 Patient perception of the usefulness of the information received

 

X

X

 Patient future consulting intentions

 

X

X

 Absenteeism

X

X

X

 Evaluation of adverse events

 

X

X

 Number of re-consultations to primary and secondary care and number of complications regarding the ALRTI

  

X

  1. Abbreviations: ALRTI acute lower respiratory tract infection, CRF case report form, CRP C-reactive protein, GP general practitioner
  2. Randomisation will take place 2 weeks before initiating the clinical trial (October 21, 2019). Workshop for GPs and nurses assigned to any of the three intervention arms at the end of October 2019
  3. *Monthly internet-based short training capsules for GPs and nurses assigned to any of the intervention groups