Managing Side Effects in Clinical Practice

Beth Israel Lahey Health

Status: Completed

Conditions: Functional Gastrointestinal Disorders

Treatments: Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03475550

2017P000179

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Standard of care 1

Active Comparator group

Description:

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".

Treatment:

Other: Standard of Care

Standard of care 2

Active Comparator group

Description:

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".

Treatment:

Other: Standard of Care