The Bronchiolitis Follow-up Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 8
- 主要终点
- Parental Anxiety
研究概览
简要总结
This study evaluates the value of routine follow-up with a child's pediatrician after hospitalization for bronchiolitis. Parents of half of participants will be instructed to follow-up with the child's pediatrician regardless of symptom resolution, while the other half will be instructed to follow-up on an as-needed basis (only if the child worsens, doesn't improve, or other concerns develop).
详细描述
Bronchiolitis is highly prevalent and burdensome among children less than 2 years of age. For this reason, many therapies have been tried by providers and studied by researchers. Unfortunately, interventions have largely been shown to be ineffective, prompting campaigns to reduce use of ineffective therapies. One commonly prescribed but thus far unstudied intervention often provided to children discharged after hospitalization for bronchiolitis is routine follow up with their pediatrician. Whether the costs and time spent for these visits are worthwhile depends on the extent to which the child and the child's parents benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis.
排除标准
- •Chronic lung disease
- •Complex or hemodynamically significant heart disease
- •Immunodeficiency
- •Neuromuscular disease
- •Discharged home with medication for withdrawal
- •Inpatient team believes the child should follow up with their PCP
结局指标
主要结局
Parental Anxiety
时间窗: Measured at the first data collection phone call (5-9 days following discharge).
Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale (HADS), a 0-28 point scale, with higher values representing higher anxiety.
次要结局
- Time From Hospital Discharge to Child Reported Back to Normal(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Number of Clinic Visits Prior to Symptom Resolution(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Any Hospital Re-admission Prior to Symptom Resolution(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids)(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Time From Hospital Discharge to Cough Resolution(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray)(Measured by parent report, at the first data collection phone call (5-9 days following discharge).)
- Relationship With PCP(Measured by parent report via research coordinator phone call at 1 month from discharge.)
- Immunizations Received 1 Month After Discharge(Measured by parent report via research coordinator phone call at 1 month from discharge.)
- Any ED Visit Prior to Symptom Resolution(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Number of Missed Work Days(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Missed Daycare(Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.)
- Report That Care Was Perfect 1 Month After Discharge(Measured by parent report via research coordinator phone call at 1 month from discharge.)