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Managing Side Effects in Clinical Practice

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475550
Enrollment
31
Registered
2018-03-23
Start date
2017-05-22
Completion date
2020-09-30
Last updated
2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders

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.

Interventions

OTHERStandard 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.

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported benefit from the drug3 weeks after the physician visitVisual Analog Scale of reported benefit from the drug (0-10)
Number of side effects reported from the drug3 weeks after the physician visitChecklist of reported side effects from the drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026