Functional Gastrointestinal DisordersNCT03475550
Managing Side Effects in Clinical Practice
A study of Functional Gastrointestinal Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Functional Gastrointestinal Disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is not seen in the Division of Gastroenterology at BIDMC
- Patient has previously taken the drug that is prescribed
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders
This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Standard of Care
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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". Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported benefit from the drug
Visual Analog Scale of reported benefit from the drug (0-10)
Measured: 3 weeks after the physician visit
Number of side effects reported from the drug
Checklist of reported side effects from the drug
Measured: 3 weeks after the physician visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 May 2017
- Primary completion30 Dec 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Lembo, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475550
- Sponsor's protocol ID
- 2017P000179
- Status last verified
- Dec 2022
- First submitted
- 14 Mar 2018
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT03475550
- Acronym / sponsor ID
- 2017P000179
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care 1 | Active comparator | Other: Standard of CarePatients 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". |
| Standard of care 2 | Active comparator | Other: Standard of CarePatients 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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patient is not seen in the Division of Gastroenterology at BIDMC
- Patient has previously taken the drug that is prescribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareThe 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. | Other | Standard of care 1, Standard of care 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Functional Gastrointestinal Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported benefit from the drug (time frame: 3 weeks after the physician visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.