Managing Side Effects in Clinical Practice

Study Overview
=================
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.

Official Title
-----------------
Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders

Conditions
-----------------
Functional Gastrointestinal Disorders

Intervention / Treatment
-----------------
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patient is not seen in the Division of Gastroenterology at BIDMC Patient has previously taken the drug that is prescribed
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care 1<br>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. | Other: Standard of Care<br>* The intervention involves clinician-provided information to patients receiving a new medication as part of their standard medical care. Intervention 1 includes more detailed information compared to Intervention 2.<br>|
| Active Comparator: Standard of care 2<br>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. | Other: Standard of Care<br>* The intervention involves clinician-provided information to patients receiving a new medication as part of their standard medical care. Intervention 1 includes more detailed information compared to Intervention 2.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported benefit from the drug | Visual Analog Scale of reported benefit from the drug (0-10) | 3 weeks after the physician visit | 
| Number of side effects reported from the drug | Checklist of reported side effects from the drug | 3 weeks after the physician visit |