Managing Side Effects in Clinical Practice
- Conditions
- Functional Gastrointestinal Disorders
- Interventions
- Other: Standard of Care
- Registration Number
- NCT03475550
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- Patient is not seen in the Division of Gastroenterology at BIDMC
- Patient has previously taken the drug that is prescribed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care 1 Standard of Care 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". Standard of care 2 Standard of Care 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".
- Primary Outcome Measures
Name Time Method Patient-reported benefit from the drug 3 weeks after the physician visit Visual Analog Scale of reported benefit from the drug (0-10)
Number of side effects reported from the drug 3 weeks after the physician visit Checklist of reported side effects from the drug
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States