Inflammatory Bowel DiseasesNCT03695783
The IBD&me Randomized Controlled Trial
A study testing Online decision aid called IBD&me and Standardized educational material in people with Inflammatory Bowel Diseases, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Online decision aid called IBD&me and Standardized educational material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 14 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U)
- Have experienced IBD related symptoms in the 30 days before screening
- Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit
- Have an IBD-related visit scheduled at least 7 days and no later than 3 months following screening
Who cannot join
- Does not speak English
- Does not have access to the Internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial
Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.
Read the detailed description
Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
Objective: The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.
Hypothesis: IBD\&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool.
Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care
- Intervention: IBD\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace
- Control arm: Standardized, high-quality educational material from the Crohn's \& Colitis Foundation
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Online decision aid called IBD&me, Standardized educational material
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online decision aid called IBD&meOther
Patients randomized to IBD\&me will be directed to go through the website at least 2 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit.
Standardized educational materialOther
Patients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource at least 2 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit.
| Study group | Role | What they receive |
|---|---|---|
| Online decision aid called IBD&me | Experimental | IBD\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace. It includes an educational component and an interactive exercise with a series of ratings tasks that generates a personalized preferences report for patients to share and discuss with their physician. Receives: Other: Online decision aid called IBD&me |
| Standardized educational material | Active comparator | PDF file corresponding to the CCFA's online resource on biologic therapies, which is a well-researched and clearly presented overview of IBD biologic therapies, but without an active shared-decision making component. Receives: Other: Standardized educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perceptions of shared decision-making
To assess the impact of the IBD\&me decision aid on patient perceptions of shared decision-making, compared to a standardized education arm. Patient perception of shared decision-making, as measured by the 9-item Shared Decision-Making Questionnaire (SDM-Q-9)
Measured: one day after the clinic visit
Secondary outcomes (4)
Patient perceptions of decisional conflict
Patient perceptions of decisional conflict, as measured using the informed and values clarity subscales of the Decisional Conflict Scale
Measured: one day after the clinic visit
Patient satisfaction
Patient satisfaction as measured by four domains of the Patient Satisfaction Questionnaire relating to communication, general satisfaction, interpersonal manner, and time spent with the doctor (PSQ-18)
Measured: one day after the clinic visit
Disease control and IBD-related quality of life
Disease control and IBD-related quality of life, as measured by the IBD-Control questionnaire
Measured: at baseline and two months after the clinic visit
Initiation or switch of a treatment
Questionnaire about IBD therapy use
Measured: at baseline and two months after the clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start6 Mar 2019
- Primary completion14 Mar 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan Spiegel, Cedars-Sinai Medical Center
- Investigators
- Brennan Spiegel, MD, MSHS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695783
- Sponsor's protocol ID
- 37998665
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2018
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03695783
- Acronym / sponsor ID
- 37998665
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 4 Oct 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.
Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.
Detailed description
Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.
Objective: The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.
Hypothesis: IBD\&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool.
Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care
- Intervention: IBD\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace
- Control arm: Standardized, high-quality educational material from the Crohn's \& Colitis Foundation
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Online decision aid called IBD&me | Experimental | Other: Online decision aid called IBD&meIBD\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace. It includes an educational component and an interactive exercise with a series of ratings tasks that generates a personalized preferences report for patients to share and discuss with their physician. |
| Standardized educational material | Active comparator | Other: Standardized educational materialPDF file corresponding to the CCFA's online resource on biologic therapies, which is a well-researched and clearly presented overview of IBD biologic therapies, but without an active shared-decision making component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U)
- Have experienced IBD related symptoms in the 30 days before screening
- Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit
- Have an IBD-related visit scheduled at least 7 days and no later than 3 months following screening
Key exclusion criteria (2 listed)
- Does not speak English
- Does not have access to the Internet
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 |
|---|---|---|
| Online decision aid called IBD&mePatients randomized to IBD\&me will be directed to go through the website at least 2 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit. | Other | Online decision aid called IBD&me |
| Standardized educational materialPatients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource at least 2 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit. | Other | Standardized educational material |
Primary outcome
Patient perceptions of shared decision-making
Time frame: one day after the clinic visit
To assess the impact of the IBD\&me decision aid on patient perceptions of shared decision-making, compared to a standardized education arm. Patient perception of shared decision-making, as measured by the 9-item Shared Decision-Making Questionnaire (SDM-Q-9)
4 secondary outcomes
Patient perceptions of decisional conflict
Time frame: one day after the clinic visit
Patient satisfaction
Time frame: one day after the clinic visit
Disease control and IBD-related quality of life
Time frame: at baseline and two months after the clinic visit
Initiation or switch of a treatment
Time frame: at baseline and two months after the clinic visit
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 2 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Brennan Spiegel, MD, MSHS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online decision aid called IBD&me and Standardized educational material in people with Inflammatory Bowel Diseases, run by Cedars-Sinai 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 5 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 2 Dec 2021. 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 perceptions of shared decision-making (time frame: one day after the clinic visit). 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 2 Dec 2021.