Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 789
- 试验地点
- 1
- 主要终点
- Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
研究概览
简要总结
The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.
- •Diagnosis codes J40-J44 will be included.
- •>=1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.
- •Age >= 65 years.
- •Self-reported health care provider diagnosis of COPD.
- •Self-reported prescription for FLUT/SAL or UMEC/VI.
- •12 months of continuous enrollment during the Baseline period.
- •Ability to complete the study survey in English.
排除标准
- •>=2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.
- •Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.
- •Claims for triple therapy (Inhaled Corticosteroid [ICS] + Long-acting Antimuscarinic [LAMA] + Long-acting Beta-agonist [LABA] during the Baseline period.
- •Evidence of lung cancer diagnosis and/or treatment
结局指标
主要结局
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
时间窗: Day 1
The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims \>= 1.
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
时间窗: Day 1
Breathlessness was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The score (Grade) was the number that best fit the participant's level of activity. The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).
次要结局
- Percentage of Participants With All Cause Healthcare Resource Utilization(12 months)
- Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts(12 months)
- Length of Stay in Hospital-Baseline All Cause Utilization Counts(12 months)
- Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics(12 months)
- Mean Count of Unique Medications-Baseline All Cause Utilization(12 months)
- Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts(12 months)
- Mean Total Baseline All Cause Healthcare Costs(12 months)
- Mean Total Number of Medications Dispensing-Baseline All Cause Utilization(12 months)
- Mean Count of Unique COPD Medications-Baseline COPD Medication(12 months)
- Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications(12 months)
- Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization(12 months)
- Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts(12 months)
- Length of Inpatient Stay-Baseline COPD Related Utilization Counts(12 months)
- Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts(12 months)
- Mean Total Baseline COPD-related Healthcare Costs(12 months)
- Number of Participants With Atleast One Baseline COPD Exacerbation(12 months)
- Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification(12 months)