Abstract

STUDY PROTOCOL TO ASSESS THE IMPACT OF “SEE AND DO” (SAD) TRIAL ON COMPETENCY OF INHALER USE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Sam Johnson Udaya Chander J.*, Santhakumar S., Sam Solomon W. D., Akelesh T., Kandasamy C. S., Arulraj P. and Venkatanarayanan R.

Abstract

Background: Inhaled medications are the primary modality of treatment for obstructive lung diseases like asthma and COPD. Poor inhaler technique leads to decreased drug delivery to the airways and poor disease outcome. Although intensive education improves inhaler skills, it deteriorates over time. Hence, a strategy ascertaining repeated education on proper inhaler use should be developed and implemented in inhaler mishandlers. This protocol aims to test the effectiveness of pharmacist-led “See-And-Do” (SAD) Trial on competency of inhaler use in patients with COPD. Methods/Design: A prospective, randomized, controlled trial is conducted at a 350-bedded tertiary care hospital in Coimbatore, India. Participants are randomly assigned to either intervention group or control group. The participants in intervention group receive three sessions of face-to-face, patient specific inhaler technique coaching, verbal instruction, and physical demonstration. The patients are provided with reminder flags highlighting the wrong steps they made at baseline check. The participants in control group receive device-specific instruction and pamphlets only. The primary outcome is change in inhaler technique score at 6 and 12 months compared to baseline. Secondary outcome is COPD control measured by FEV1/FVC ratio. Discussion: This study will demonstrate the utilization of pharmacist-led intervention to improve inhaler technique and to better manager COPD, thereby minimizing the healthcare utilization cost in the country. This study also will assess the possibility of implementing such programs in all hospitals throughout the country. Clinical Trial Registration: The study was retrospectively registered in the Clinical Trial Registry of India (CTRI/2017/05/008526) dated May 9, 2017.

Keywords: Inhaler technique, Chronic Obstructive Pulmonary Disease, Clinical Pharmacist, Reminder Flags.