Managing Side Effects in Clinical Practice
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ClinicalTrials.gov Identifier: NCT03475550 |
Recruitment Status : Unknown
Verified December 2019 by Anthony Lembo, Beth Israel Deaconess Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : March 23, 2018
Last Update Posted : December 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Functional Gastrointestinal Disorders | Other: Standard of Care | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders |
Actual Study Start Date : | May 22, 2017 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |

Arm | Intervention/treatment |
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Active Comparator: Standard of care 1
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".
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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. |
Active Comparator: Standard of care 2
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".
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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. |
- 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)
- Number of side effects reported from the drug [ Time Frame: 3 weeks after the physician visit ]Checklist of reported side effects from the drug

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475550
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Responsible Party: | Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT03475550 |
Other Study ID Numbers: |
2017P000179 |
First Posted: | March 23, 2018 Key Record Dates |
Last Update Posted: | December 23, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastrointestinal Diseases Digestive System Diseases |