Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC)-Community Pharmacy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Compliance with inhaled corticosteroids
研究概览
简要总结
This study seeks to determine whether education provided in community pharmacies and monthly reminder calls can improve compliance with asthma medications.
We hypothesize that those pediatric patients with asthma 12 months to 12 years of age who receive comprehensive asthma care as part of a validated intervention (1) who are randomized to receive enhanced community pharmacy care will have significantly greater compliance with inhaled corticosteroids (ICS) six months after enrollment when compared with patients receiving usual pharmacy care. As secondary outcomes, we further hypothesize that they will have less unscheduled healthcare utilization and improved functional outcomes and QOL.
(1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.
详细描述
IMPACT DC has been funded by the National Association of Chain Drug Stores Foundation (NACDSF) to undertake a project regarding coordination between the existing IMPACT DC Asthma Clinic and certain community pharmacies in Northwest, Northeast, and Southeast DC that provide patients with asthma medications, devices, and education.
This is a single blind prospective randomized clinical trial in which eligible patients with asthma aged 12m to 12y, inclusive, seen in the current IMPACT DC Asthma Clinic and prescribed ICS as controller medications is randomized to either "usual pharmacy care" or "enhanced pharmacy care." The IMPACT DC Asthma Clinic is an ED-based follow-up clinic that has been shown to improve outcomes. (1)
Outcomes will be assessed by blinded and structured patient phone interview at 1, 3, and 6 months.
Patients randomized to usual pharmacy care will fill prescriptions by their usual preferred method, whereas patients randomized to enhanced pharmacy care will have these same prescriptions electronically transmitted to specifically trained pharmacists at one of the participating community pharmacies. Both "usual pharmacy care" and "enhanced pharmacy care" will be provided within all participating pharmacy sites.
Community pharmacies located in five zip codes in Northeast and Southeast DC with the highest absolute numbers of pediatric ED asthma visits to hospital in the District (20019, 20020, 20032, 20002, 20011) will be selected for the program based on their geographic distribution and ability to meet programmatic expectations. Pharmacies will receive electronically transmitted, faxed or verbal prescriptions from the IMPACT DC Asthma Clinic staff for patients identified as study participants in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include:
- •age between 12 months and 12 years, inclusive;
- •prior physician-diagnosed asthma;
- •prescription of an inhaled corticosteroid during the IMPACT DC Asthma Clinic visit,
- •a parent/guardian available for interview;
- •residence in one of the 5 zip codes in Washington, DC with the highest absolute numbers for asthma visits to the Emergency Department at Childrens National Medical Center (20019, 20020, 20032, 20002, 20011), and
- •insurance that covers at least part of the cost of medications.
排除标准
- •Exclusion criteria include:
- •significant medical co-morbidities affecting the cardiorespiratory system;
- •enrollment in another asthma research study;
- •unavailability for telephone follow-up; or
- •primary language other than English.
结局指标
主要结局
Compliance with inhaled corticosteroids
时间窗: 6 months following enrollment
次要结局
- Unscheduled healthcare utilization for asthma(6 months following enrollment)
- Quality of Life(6 months following enrollment)
研究者
Stephen J. Teach, MD, MPH
Chief, Division of Allergy and Immunology
Children's National Research Institute