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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS021747 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| University of Pittsburgh | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| Cedars-Sinai Medical Center |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients choosing Combination therapy | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to initiation of therapy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corey A Siegel, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Atlanta Gastroenterology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36377259 | Derived | 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. |
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| OTHER |
| University of Maryland | OTHER |
| Brigham and Women's Hospital | OTHER |
| Thomas Jefferson University | OTHER |
| University of Chicago | OTHER |
| Atlanta Gastroenterology Associates | OTHER |
| Long Island Clinical Research Associates | UNKNOWN |
| Center for Digestive and Liver Diseases | UNKNOWN |
| Charlotte Gastroenterology and Hepatology | UNKNOWN |
| Minnesota Gastroenterology | UNKNOWN |
| Ohio Gi and Liver Institute | UNKNOWN |
| Winthrop University Hospital | OTHER |
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|
| Week 1, Week 2, week 26, week 52, week 78, week 110 |
| Persistence (adherence) with chosen therapy | Week 1, Week 2, week 26, week 52, week 78, week 110 |
| Quality of Decision | i. Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician | Week 1, Week 2, week 26, week 52, week 78, week 110 |
| Cost of Care | Crohn's disease related costs at 2 years | week 110 |
| Remission | Proportion of patients in clinical remission | 6 months, 1 year, 2 years |
| Patients on Steroids | Proportion of patients taking steroids | 6 months, 1 year, 2 years |
| Surgeries | Proportion of patients requiring Crohn's disease related surgery | 6 months, 1 year, 2 years |
| Crohn's disease related hospitalizations | Number of hospitalizations | 6 months, 1 year, 2 years |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21043 | United States |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
| Minnesota Gastroenterology | Plymouth | Minnesota | 55446 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | 28207 | United States |
| Ohio GI and Liver Institute | Cincinnati | Ohio | 45219 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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