Managing Side Effects in Clinical Practice

NCT03475550 | Completed

• 1 other identifier: 2017P000179
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

• Patient-reported benefit from the drug

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

  3 weeks after the physician visit

• Number of side effects reported from the drug

  Checklist of reported side effects from the drug

  3 weeks after the physician visit

Study Arms (2)

Standard of care 1

ACTIVE COMPARATOR

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".

Other: Standard of Care

Standard of care 2

ACTIVE COMPARATOR

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".

Other: Standard of Care

Interventions

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.

Standard of care 1; Standard of care 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is not seen in the Division of Gastroenterology at BIDMC
• Patient has previously taken the drug that is prescribed

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: May 22, 2017
• Primary Completion: December 30, 2019
• Study Completion: September 30, 2020
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

US (1)