An interventional study of C-reactive protein rapid testing and Communication skill enhancement in Respiratory Tract Infections and Cough, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment
Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed.
Background: Most antibiotics are prescribed in primary care, and most commonly for acute lower respiratory infections (ALRTI). Despite their marginal benefit, about 60% of these infections are currently treated with antibiotics in Catalonia, Spain. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of C-reactive protein (CRP) rapid testing and the improvement of the communication skills being the most effective interventions. However, most studies have been carried out outside Mediterranean countries. This study aims to evaluate the effectiveness and the efficiency of a continuous disease-focused intervention (CRP) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.
Methods/design: A cluster, randomised, factorial, controlled trial aimed at including 20 primary care centres (n=2,940 patients) with patients older than 18 years presenting for a first consultation with ALRTI, therefore with presence of infected acute cough of up to 3 weeks' duration as the predominant symptom. Centres, according to socioeconomic and antibiotic consumption, will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the perspective of public health system. A qualitative study aimed at identifying the expectations and concerns in patients with ALRTIs and the satisfaction of clinicians with the different interventions will also be performed. Clinicians assigned to the interventions will participate in a 2-hour training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the trial. Clinical effectiveness will be measured by the antibiotic use within the first 6 weeks and the quality adjusted life years and secondary outcomes will be duration of illness and severity of cough measured with a symptom diary, healthcare reconsultations, hospital admissions and complications. National health care perspective will be adopted and the temporal horizon of the analysis will be one year. Health care costs will be considered and expressed in € of the current year of the analysis. Univariate and multivariate sensitivity analysis will be carried out.
Discussion: The ISAAC-CAT project aims to improve the management of ALRTIs in primary care through use of two different clinicians' skills to help target antibiotic prescribing only to those most likely to benefit, and thereby reduce the risk of unnecessary exposure to antibiotics leading to adverse effects and/or the development of AMR without having a negative impact on health status, thus benefiting individual patients and society at large. This project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual guidelines.
1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.
This study's planned enrollment of 2,940 is above the median of 196 across 715 interventional studies indexed under Respiratory Tract Infections.
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Exclusion Criteria:
Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing.
Diagnostic Test: C-reactive protein rapid testing
Continuous (on-site and monthly online training) illness-focused intervention with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.
Procedure: Communication skill enhancement
Continuous (workshop and monthly web-based training) disease-focused intervention with C-reactive protein rapid testing and on-site and continuous (monthly online training illness-focused intervention) with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.
Diagnostic Test: C-reactive protein rapid testing · Procedure: Communication skill enhancement
Usual care.
Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.
Also known as: CRP
Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.
Also known as: Leaflet provision
Antibiotic use
Number of antibiotics consumed (as documented in the CRFs and double-checked by the Pharmacy Unit of Institut Català de Salut that can track if the antibiotic has been dispensed at any of the Catalan pharmacies)
Time frame: Day 42
Health status
Quality of life score obtained using the EuroQol questionnaire
Time frame: Difference between baseline visit and day 42
Re-consultations and complications
Number of re-consultation for new or worsening symptoms, new signs, or hospital admission, assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data), and Number of complications regarding the ALRTI
Time frame: Day 42
Duration of symptoms and duration of severe symptoms
Number of days until symptoms are rated daily as 0 (no problem) (information is reported by patients in self-completed diaries)
Time frame: Day 42
Antibiotic prescription at the baseline visit
Number of antibiotic prescriptions at the baseline visit, differentiating immediate and delayed antibiotic prescribing, and antibiotic dispensing at the pharmacies
Time frame: Baseline visit
Drugs other than antibiotics
Number of non-antibiotic prescriptions (reported by patients in self-completed diaries)
Time frame: Day 42
Tests ordered by clinicians
Number of tests ordered by clinicians (reported in the CRF)
Time frame: Day 42
Patient satisfaction with care
Patient satisfaction score reported in the symptom diary. Measured with a question that has used in previous studies: How satisfied are you with the consultation? Range from 0 (nothing satisfied) to 5 (extremely satisfied).
Time frame: Day 14
Patient perception of the usefulness of the information received.
Patient perception score about the usefulness of the information received. Measured with a question that has used in previous studies: Do you consider that the information received from your doctor has been useful? Range from 0 (nothing useful) to 5 (extremely useful).
Time frame: Day 14
Patient future consulting intention
Patient future consulting intention score. Measured with a question that has used in previous studies: Do you think you will attend the doctor in future occasions in case you present the same symptoms? Range from 0 (totally unlikely) to 5 (sure).
Time frame: Day 14
Serious adverse events
Number of serious adverse events (assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data)
Time frame: Day 42
Absenteeism
Number of days of sick leave (collected in the CRFs)
Time frame: Baseline visit
Plan to share: Yes — Reposition in SCENTIA
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: First 15 years after publication
Access criteria: On demand
Data sharing details ↗ · scientiasalut.gencat.cat
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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