Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT

Jaap Ca Trappenburg,Evelyn M Monninkhof,Thierry Troosters,Jan-Willem J Lammers,Augustinus Jp Schrijvers,Theo Jm Verheij,Jean Bourbeau,Lieselotte Koevoets,Gerdien H De Weert-Van Oene

doi:10.1186/1471-2466-9-52

Jaap Ca Trappenburg, Evelyn M Monninkhof + Show 7 more

Open Access

https://doi.org/10.1186/1471-2466-9-52

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Abstract

BackgroundEarly detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this.Methods/DesignThe current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse clinics and allocated to either usual care or the AP intervention. The AP provides individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a color coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is the primary study outcome. Additionally, healthcare utilization, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline and 6 months. We aim at including 245 COPD patients from 7 hospitals and 5 general practices to capture the a-priori sample size of at least 73 exacerbations per study arm.DiscussionThis RCT identifies if an AP is an effective component of self-management in patients with COPD and clearly differentiates from existing studies in its design, outcome measures and generalizability of the results considering that the study is carried out in multiple sites including general practices.Trial RegistrationNCT00879281

Highlights

Detection of exacerbations by Chronic obstructive pulmonary disease (COPD) patients initiating prompt interventions has shown to be clinically relevant
Data are still insufficient to draw conclusions in terms of clinical outcomes or healthcare utilization. These findings highlight the need for continued research in this field using high quality randomized controlled trials with adequate sample size. This present study aims at evaluating the effectiveness of an Action Plan (AP) as an addition to care as usual in a randomized controlled trial
Using the modified informed consent procedure in our trial, we deal with the following threats to internal validity: Selection bias by attrition or dropout Patients' preference for allocation to the treatment arm and receiving "the innovation" above care as usual might result in increased dropout in the control group, due to being dissatisfied or lack of interest[19]

Summary

Introduction

Detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. This airflow limitation is usually progressive and associated with an abnormal response to noxious particles or gases [1]. Exacerbations are important because of their impact on morbidity and mortality. They may hasten disease progression by accelerating the decline in lung function [3,4] and have a significant effect on quality of life [5,6]. Adjusted for disease severity, patients with exacerbations show higher mortality rates than patients without exacerbations [7,8]

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