Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— MARU  

Official title:

Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients-Retrospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359122
• Other study ID #: D2287R00123
• Status: Completed
• Start date: June 7, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: July 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Description:

Objectives: The primary objective of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City health insurance database.

Data Source(s): Guangzhou city health insurance database will be used for this study. All outpatient and inpatient visits for one patient during 2014-2016 were available.

Study Population: This study will include patients with a physician COPD diagnosis in Guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. The rough sample size of the study population was 49,000.

Outcome(s):

1. Indicators of COPD control: exacerbations;

2. Health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ED) visit number;

3. Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization expenditure.

Statistical Analysis:

Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. Categorical variables will be summarized by frequency counts and percentages at each category. Number of patients and number of missing for each variable will be summarized.

Logistic regression will be used to estimate the risk of any hospitalization. Generalized Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure.

For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the association of medication class and health resource utilization if applicable. The interaction of medication class * adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10067
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed with COPD in 2015;

2. Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up;

3. Patients had at least one COPD exacerbation during 1 year prior to the index date;

4. Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence.

Exclusion Criteria:

1. Inability to determine diagnoses from claims;

2. Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Research site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicators of COPD control	Number of exacerbations	2015.01-2016.12
Primary	Health resource utilization	Annual number of inpatient days	2015.01-2016.12
Primary	Costs of inpatient treatment	Cost of COPD exacerbation inpatient treatment	2015.01-2016.12
Primary	Health resource utilization	Inpatient visit number	2015.01-2016.12
Primary	Health resource utilization	Emergency department (ED) visit number	2015.01-2016.12
Primary	Costs of inpatient treatment	Cost of all-cause inpatient treatment	2015.01-2016.12

External Links

•   CSR Synopsis