Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough (ISAAC-CAT)

• ClinicalTrials.gov Identifier: NCT03931577
• Recruitment Status: Not yet recruiting
• First Posted: April 30, 2019
• Last Update Posted: April 30, 2019
• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Universitat Internacional de Catalunya; Fundacio d'Atencio Primaria; Universitat Pompeu Fabra
• Information provided by (Responsible Party): Jordi Gol i Gurina Foundation

Tracking Information

• First Submitted Date: April 8, 2019
• First Posted Date: April 30, 2019
• Last Update Posted Date: April 30, 2019
• Estimated Study Start Date: November 1, 2019
• Estimated Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2019)

• Antibiotic use [ Time Frame: Day 42 ]
  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)
• Health status [ Time Frame: Difference between baseline visit and day 42 ]
  Quality of life score obtained using the EuroQol questionnaire

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 29, 2019)

• Re-consultations and complications [ Time Frame: Day 42 ]
  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
• Duration of symptoms and duration of severe symptoms [ Time Frame: Day 42 ]
  Number of days until symptoms are rated daily as 0 (no problem) (information is reported by patients in self-completed diaries)
• Antibiotic prescription at the baseline visit [ Time Frame: Baseline visit ]
  Number of antibiotic prescriptions at the baseline visit, differentiating immediate and delayed antibiotic prescribing, and antibiotic dispensing at the pharmacies
• Drugs other than antibiotics [ Time Frame: Day 42 ]
  Number of non-antibiotic prescriptions (reported by patients in self-completed diaries)
• Tests ordered by clinicians [ Time Frame: Day 42 ]
  Number of tests ordered by clinicians (reported in the CRF)
• Patient satisfaction with care [ Time Frame: Day 14 ]
  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).
• Patient perception of the usefulness of the information received. [ Time Frame: Day 14 ]
  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).
• Patient future consulting intention [ Time Frame: Day 14 ]
  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).
• Serious adverse events [ Time Frame: Day 42 ]
  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)
• Absenteeism [ Time Frame: Baseline visit ]
  Number of days of sick leave (collected in the CRFs)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough
• Official Title: 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.
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Cluster randomised factorial controlled trial.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Respiratory Tract Infections
• Cough

Intervention

• Diagnostic Test: C-reactive protein rapid testing
  Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.
  Other Name: CRP
• Procedure: Communication skill enhancement
  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.
  Other Name: Leaflet provision

Study Arms

• Experimental: C-reactive protein rapid testing
  Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing.
  Intervention: Diagnostic Test: C-reactive protein rapid testing
• Experimental: Enhancement of communication skills
  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.
  Intervention: Procedure: Communication skill enhancement
• Experimental: C-reactive protein + communication skills
  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.
  Interventions:

  • Diagnostic Test: C-reactive protein rapid testing
  • Procedure: Communication skill enhancement
• No Intervention: Usual care
  Usual care.

Publications *

• Medina-Perucha L, García-Sangenís A, Moragas A, Gálvez-Hernández P, Cots JM, Lanau-Roig A, Borràs A, Amo I, Monfà R, Llor C, Berenguera A. Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study. PLoS One. 2020 Dec 18;15(12):e0244432. doi: 10.1371/journal.pone.0244432. eCollection 2020.
• Ruiz R, Moragas A, Trapero-Bertran M, Sisó A, Berenguera A, Oliva G, Borràs-Santos A, García-Sangenís A, Puig-Junoy J, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfà R, Troncoso A, Abellana RM, Gálvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragán N, Llor C. 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. Trials. 2019 Dec 17;20(1):740. doi: 10.1186/s13063-019-3727-3.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 29, 2019): 2940
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age equal or older than 18 years
• first consultation for acute cough (new cough or worsening of a previous cough) as the predominant symptom
• of up to 3 weeks' duration
• which the clinician believes to be an infectious acute lower respiratory tract infection

Exclusion Criteria:

• a working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux, or allergy
• use of antibiotics in the previous two weeks
• immunological deficiencies, and/or
• inability to provide informed consent or unable to follow the study procedures

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ana Moragas, MD PhD; 0034600072170 ext 0034600072170; anamaria.moragas@urv.cat

Contact: Ana Garcia-Sangenis, MD; 0034934824124 ext 0034934824124; agarcia@idiapjgol.org

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03931577
• Other Study ID Numbers: P18/227
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Reposition in SCENTIA
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: First 15 years after publication
• Access Criteria: On demand
• URL: http://scientiasalut.gencat.cat

• Responsible Party: Jordi Gol i Gurina Foundation
• Study Sponsor: Jordi Gol i Gurina Foundation

Collaborators

• Universitat Internacional de Catalunya
• Fundacio d'Atencio Primaria
• Universitat Pompeu Fabra

Investigators

• Study Chair: Rosa Morros, MD PhD; Clinical pharmacologist

• PRS Account: Jordi Gol i Gurina Foundation
• Verification Date: April 2019