Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of side effects reported from the drug
研究概览
简要总结
This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).
详细描述
The purpose of this study is to evaluate patients' reported experiences with regularly prescribed medications. No medications are prescribed as part of this study. Rather, if a patient are prescribed a new medication during their regularly scheduled clinic visit, he/she may be eligible to participate.
Patients who agree to participate and who are prescribed a medication in clinic will be contacted by telephone or email 3 weeks after their appointment to evaluate positive and negative experiences with the medication.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is seen in the Division of Gastroenterology at BIDMC
- •Patient is prescribed a medication for the treatment of functional gastrointestinal disorders that has not previously been tried by the patient
排除标准
- •Patient is not seen in the Division of Gastroenterology at BIDMC
- •Patient has previously taken the drug that is prescribed
研究组 & 干预措施
Standard of care 1
Patients will receive one of 2 different descriptions of the medication's risks and benefits. Both descriptions meet ethical standards of transparency and respect for person and are commonly used but have never been compared. "Standard of Care 1" includes more details than "Standard of Care 2".
干预措施: Standard of Care (Other)
Standard of care 2
Patients will receive one of 2 different descriptions of the medication's risks and benefits. Both descriptions meet ethical standards of transparency and respect for person and are commonly used but have never been compared. "Standard of Care 2" includes fewer details than "Standard of Care 1".
干预措施: Standard of Care (Other)
结局指标
主要结局
Number of side effects reported from the drug
时间窗: 3 weeks after the physician visit
Checklist of reported side effects from the drug
Patient-reported benefit from the drug
时间窗: 3 weeks after the physician visit
Visual Analog Scale of reported benefit from the drug (0-10)
次要结局
未报告次要终点
研究者
Anthony Lembo
Associate Professor of Medicine
Beth Israel Deaconess Medical Center