Crohn's DiseaseNCT02084290
Evaluating a Shared Decision Making Program for Crohn's Disease
A study testing Shared Decision Making Program in people with Crohn's Disease, run by Dartmouth-Hitchcock Medical Center at 14 sites in United States.
Trial summary
Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on patients' treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Shared Decision Making Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2014to 31 Dec 2018
- 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
- Clinical diagnosis of Crohn's Disease based on standard clinical, radiographic, endoscopic, and histologic criteria
- Age 18 or older
- Fluent, English Speaking
- A candidate to receive immunomodulators or anti-TNF therapy based on their providers recommendation
- not currently taking immunomodulators (6-mercapropurine, azathioprine, methotrexate) or anti-TNF agents (infliximab, adalimumab, certolizumab pegol)
Who cannot join
- Participant in a pilot study/focus group for development of Crohn's Shared Decision Making Program
- Currently taking any medication that is contraindicated to take together with an immunomodulator or anti-TNF agent
- Known intolerance to either immunomodulators or anti-TNF agents
- Lack of accessibility to e-mail for follow-up surveys
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
University of Maryland Medical Center
Baltimore, Maryland, 21043
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
University of Chicago
Chicago, Illinois, 60637
Ohio GI and Liver Institute
Cincinnati, Ohio, 45219
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Winthrop University Hospital
Mineola, New York, 11501
Mount Sinai Medical Center
New York, New York, 10029
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Minnesota Gastroenterology
Plymouth, Minnesota, 55446
About this study
Official title: Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease
Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on patients' treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes
Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for them and will lead to a higher acceptance of appropriate therapy, improved persistence with chosen therapy, lower costs and improved clinical outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial to:
Read more
- Determine how the shared decision making program influences patients' choice of therapy
- Evaluate how the shared decision making program affects persistence with chosen therapy
- Determine how the shared decision making program affects decision quality
- Determine how the shared decision making program influences cost of care and clinical outcomes
Expected Outcome and Impact: Investigators expect that this program will influence patients' choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes. Investigators believe that this product can be successfully operationalized in the clinic to establish a new paradigm of how providers can communicate personalized treatment options to patients across a broad range of diseases.
- Conditions
- Crohn's Disease
- Being tested
- Shared Decision Making Program
- Keywords
- Crohn's disease, Shared Decision Making, Decision Aid
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making ProgramBehavioural
This study is cluster randomized by study-site, Subjects enrolled at intervention sites will access an educational program and risk prediction tool. Their decisions about treatments will be compared to subjects that did not view the educational program or risk prediction tool.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Program | Experimental | Patients will have access to an educational decision making program and a risk prediction model, this web based program will be sent subjects in the intervention arm upon enrollment, they can access the program as many times as they wish. Receives: Behavioral: Shared Decision Making Program |
| Control | No intervention | Subjects enrolled at sites participating as control arms will access the same web-based surveys as the intervention group, and receive the same contacts from the study coordinator as the subjects enrolled at intervention sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients choosing Combination therapy
Measured: Week 1
Secondary outcomes (9)
Time to initiation of therapy
Measured: Week 1, Week 2, week 26, week 52, week 78, week 110
Patient Choice of therapy
no therapy, immunomodulator monotherapy, anti-TNF monotherapy, Combination therapy
Measured: Week 1, Week 2, week 26, week 52, week 78, week 110
Persistence (adherence) with chosen therapy
Measured: Week 1, Week 2, week 26, week 52, week 78, week 110
Quality of Decision
- Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician
Measured: Week 1, Week 2, week 26, week 52, week 78, week 110
Cost of Care
Crohn's disease related costs at 2 years
Measured: week 110
Remission
Proportion of patients in clinical remission
Measured: 6 months, 1 year, 2 years
Patients on Steroids
Proportion of patients taking steroids
Measured: 6 months, 1 year, 2 years
Surgeries
Proportion of patients requiring Crohn's disease related surgery
Measured: 6 months, 1 year, 2 years
Crohn's disease related hospitalizations
Number of hospitalizations
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion31 Aug 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Pittsburgh, MOUNT SINAI HOSPITAL, Cedars-Sinai Medical Center, University of Maryland, Brigham and Women's Hospital, Thomas Jefferson University, University of Chicago, Atlanta Gastroenterology Associates, Long Island Clinical Research Associates, Center for Digestive and Liver Diseases, Charlotte Gastroenterology and Hepatology, Minnesota Gastroenterology, Ohio Gi and Liver Institute, Winthrop University Hospital
- Responsible party
- Principal investigator, Corey Siegel, Dartmouth-Hitchcock Medical Center
- Investigators
- Corey A Siegel, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084290
- Sponsor's protocol ID
- AHRQR01 HS21747 D13129
- Other IDs
- R01HS021747
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2014
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zisman-Ilani Y, Thompson KD, Siegel LS, Mackenzie T, Crate DJ, Korzenik JR, Melmed GY, Kozuch P, Sands BE, Rubin DT, Regueiro MD, Cross R, Wolf DC, Hanson JS, Schwartz RM, Vrabie R, Kreines MD, Scherer T, Dubinsky MC, Siegel CA. Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial. Aliment Pharmacol Ther. 2023 Jan;57(2):205-214. doi: 10.1111/apt.17286. Epub 2022 Nov 14.
PubMed 36377259
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02084290
- Acronym / sponsor ID
- AHRQR01 HS21747 D13129
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Shared Decision Making, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Pittsburgh, MOUNT SINAI HOSPITAL, Cedars-Sinai Medical Center, University of Maryland, Brigham and Women's Hospital, Thomas Jefferson University, University of Chicago, Atlanta Gastroenterology Associates, Long Island Clinical Research Associates, Center for Digestive and Liver Diseases, Charlotte Gastroenterology and Hepatology, Minnesota Gastroenterology, Ohio Gi and Liver Institute, Winthrop University Hospital
- Study start
- Mar 2014
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on patients' treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes
Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for them and will lead to a higher acceptance of appropriate therapy, improved persistence with chosen therapy, lower costs and improved clinical outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial to:
- Determine how the shared decision making program influences patients' choice of therapy
- Evaluate how the shared decision making program affects persistence with chosen therapy
- Determine how the shared decision making program affects decision quality
- Determine how the shared decision making program influences cost of care and clinical outcomes
Expected Outcome and Impact: Investigators expect that this program will influence patients' choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes. Investigators believe that this product can be successfully operationalized in the clinic to establish a new paradigm of how providers can communicate personalized treatment options to patients across a broad range of diseases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Program | Experimental | Behavioral: Shared Decision Making ProgramPatients will have access to an educational decision making program and a risk prediction model, this web based program will be sent subjects in the intervention arm upon enrollment, they can access the program as many times as they wish. |
| Control | No intervention | –Subjects enrolled at sites participating as control arms will access the same web-based surveys as the intervention group, and receive the same contacts from the study coordinator as the subjects enrolled at intervention sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Crohn's Disease based on standard clinical, radiographic, endoscopic, and histologic criteria
- Age 18 or older
- Fluent, English Speaking
- A candidate to receive immunomodulators or anti-TNF therapy based on their providers recommendation
- not currently taking immunomodulators (6-mercapropurine, azathioprine, methotrexate) or anti-TNF agents (infliximab, adalimumab, certolizumab pegol)
Key exclusion criteria (4 listed)
- Participant in a pilot study/focus group for development of Crohn's Shared Decision Making Program
- Currently taking any medication that is contraindicated to take together with an immunomodulator or anti-TNF agent
- Known intolerance to either immunomodulators or anti-TNF agents
- Lack of accessibility to e-mail for follow-up surveys
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 |
|---|---|---|
| Shared Decision Making ProgramThis study is cluster randomized by study-site, Subjects enrolled at intervention sites will access an educational program and risk prediction tool. Their decisions about treatments will be compared to subjects that did not view the educational program or risk prediction tool. | Behavioural | Shared Decision Making Program |
Primary outcome
Proportion of patients choosing Combination therapy
Time frame: Week 1
9 secondary outcomes
Time to initiation of therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Patient Choice of therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Persistence (adherence) with chosen therapy
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Quality of Decision
Time frame: Week 1, Week 2, week 26, week 52, week 78, week 110
Cost of Care
Time frame: week 110
Remission
Time frame: 6 months, 1 year, 2 years
Patients on Steroids
Time frame: 6 months, 1 year, 2 years
Surgeries
Time frame: 6 months, 1 year, 2 years
Crohn's disease related hospitalizations
Time frame: 6 months, 1 year, 2 years
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 7 Feb 2019.
- Derived from this study: PubMed 36377259Zisman-Ilani Y, Thompson KD, Siegel LS, Mackenzie T, Crate DJ, Korzenik JR, Melmed GY, Kozuch P, Sands BE, Rubin DT, Regueiro MD, Cross R, Wolf DC, Hanson JS, Schwartz RM, Vrabie R, Kreines MD, Scherer T, Dubinsky MC, Siegel CA. Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial. Aliment Pharmacol Ther. 2023 Jan;57(2):205-214. doi: 10.1111/apt.17286. Epub 2022 Nov 14.
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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.
Corey A Siegel, MD principal investigator
Dartmouth-Hitchcock Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making Program in people with Crohn's Disease, run by Dartmouth-Hitchcock Medical Center at 14 sites 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 4 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Proportion of patients choosing Combination therapy (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084290, which also lists 1 linked publication.
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 7 Feb 2019.