title: Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease (COPD) accounts for 10-12 % of primary care consultations, 7 % of hospital admissions and 35 % of chronic incapacity related to productivity. The misuse of inhalers is a significant problem in COPD because it is associated with reduced therapeutic drug effects leading to lack of control of both symptoms and disease. Despite all advice, health care professionals' practice management of inhalation treatments is usually deficient. Interventions to improve inhaler technique by health care professionals are limited, especially among primary care professionals, who provide the most care to patients with COPD. The aim of this study is to evaluate the efficacy of an educational intervention to train general practitioners (GPs) in the right inhalation technique for the most commonly used inhalers.
  
  
  METHODS
  We are conducting a pragmatic cluster randomised controlled trial. The sample population is composed of 267 patients diagnosed with COPD using inhalation therapy selected from among those in 20 general practices, divided into two groups (control and intervention) by block randomisation at 8 primary care centres. The sample has two levels. The first level is patients with COPD who agree to participate in the trial and receive the educational intervention from their GPs. The second level is GPs who are primary health care professionals and receive the educational intervention. The intervention is one session of the educational intervention with a monitor given to GPs for training in the right inhalation technique. The primary outcome is correct inhalation technique in patients. Secondary outcomes are functional status (spirometry) and quality of life. The follow-up period will be 1 year. GPs will have two visits (baseline and at the 1-year follow-up visit. Patients will have four visits (at baseline and 3, 6 and 12 months). Analysis will be done on an intention-to-treat basis.
  
  
  CONCLUSIONS
  We carried out three previous clinical trials in patients with COPD, which showed the efficacy of an educational intervention based on monitor training to improve the inhalation technique in patients. This intervention is suitable and feasible in the context of clinical practice. Now we are seeking to know if we can improve it when the monitor is the GP (the real care provider in daily practise).
  
  
  BACKGROUND
  ISRCTN Registry identifier ISRCTN93725230 . Registered on 18 August 2014.
authors.affiliation: Vélez Sur Primary Care Centre / IBIMA Institute, Málaga Este-Axarquía Health Area / Málaga University, Vélez Málaga, Málaga, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Leiva-Fernández
authors.affiliation: Multiprofessional Family and Community Attention Teaching Unit, Málaga-Guadalhorce Trust, Málaga University, Málaga, Spain.
authors.forename: Rubén L
authors.initials: RL
authors.lastname: Vázquez-Alarcón
authors.affiliation: Multiprofesional Family and Community Medicine Attention Teaching Unit, Málaga-Guadalhorce Trust, Málaga University, Málaga, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Aguiar-Leiva
authors.affiliation: Multiprofesional Family and Community Medicine Attention Teaching Unit, Málaga-Guadalhorce Trust, Málaga University, Málaga, Spain.
authors.forename: Mireya
authors.initials: M
authors.lastname: Lobnig-Becerra
authors.affiliation: Multiprofessional Family and Community Attention Teaching Unit / IBIMA Institute, Málaga-Guadalhorce Trust / Málaga University, Málaga, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: Leiva-Fernández
authors.affiliation: Multiprofessional Family and Community Attention Teaching Unit / IBIMA Institute, Málaga-Guadalhorce Trust / Málaga University, Málaga, Spain. mariapbarnestein@gmail.com.
authors.forename: Pilar
authors.initials: P
authors.lastname: Barnestein-Fonseca
mesh_terms: D000280:Administration, Inhalation; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004502:Education, Medical, Continuing / Q000379:methods*; D058005:General Practitioners / Q000193:education*; D006801:Humans; D007318:Inservice Training / Q000379:methods*; D057194:Intention to Treat Analysis; D009330:Nebulizers and Vaporizers; D010353:Patient Education as Topic / Q000379:methods*; D011320:Primary Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D019141:Respiratory System Agents / Q000008:administration & dosage*; D013030:Spain; D013647:Task Performance and Analysis
chemical_list: D019141:Respiratory System Agents
keywords: COPD; Educational intervention; Inhalation techniques; Primary care professionals