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OpenTrials
Completed

NCT Number: NCT03475550

Managing Side Effects in Clinical Practice

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

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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.

Primary outcomes

  1. Patient-reported benefit from the drug

    Time frame: 3 weeks after the physician visit

    Visual Analog Scale of reported benefit from the drug (0-10)

  2. Number of side effects reported from the drug

    Time frame: 3 weeks after the physician visit

    Checklist of reported side effects from the drug

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 23, 2018
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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