Managing Side Effects in Clinical Practice

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475550
• Other study ID #: 2017P000179
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Other:
• Standard of Care
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported benefit from the drug	Visual Analog Scale of reported benefit from the drug (0-10)	3 weeks after the physician visit
Primary	Number of side effects reported from the drug	Checklist of reported side effects from the drug	3 weeks after the physician visit