Back to resultsManaging Side Effects in Clinical Practice
Primary Purpose
Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Sponsored by
About this trial
This is an interventional health services research trial for Functional Gastrointestinal Disorders
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of care 1
Standard of care 2
Arm 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".
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".
Outcomes
Primary Outcome Measures
Patient-reported benefit from the drug
Visual Analog Scale of reported benefit from the drug (0-10)
Number of side effects reported from the drug
Checklist of reported side effects from the drug
Secondary Outcome Measures
Full Information
NCT ID
NCT03475550
First Posted
March 14, 2018
Last Updated
December 13, 2022
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03475550
Brief Title
Managing Side Effects in Clinical Practice
Official Title
Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care 1
Arm Type
Active Comparator
Arm 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".
Arm Title
Standard of care 2
Arm Type
Active Comparator
Arm 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".
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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 Outcome Measure Information:
Title
Patient-reported benefit from the drug
Description
Visual Analog Scale of reported benefit from the drug (0-10)
Time Frame
3 weeks after the physician visit
Title
Number of side effects reported from the drug
Description
Checklist of reported side effects from the drug
Time Frame
3 weeks after the physician visit
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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Managing Side Effects in Clinical Practice
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