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| ID | Type | Description | Link |
|---|---|---|---|
| DI-2021C3-24262 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values.
TRIAD Patient Surveys is a cross-sectional survey design that will lead to more informed decision making and better outcomes related to antibiotics for appendicitis.
TRIAD was developed from questions raised by the University of Washington CODA Trial that addressed many of the methodological issues in the European studies and included diverse, adult patients (n=1552) with almost all types of presentations of appendicitis.
TRIAD surveys will be carried out in clinics and hospitals across the United States. Patients who are diagnosed with appendicitis will be recruited for study participation regardless of which treatment (appendectomy or antibiotics) they receive. Investigators invite patients to participate in a survey designed to identify awareness of treatment options and levels of decisional conflict (measured with the Ottawa Decisional Conflict Score [DCS]). Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent at 30 days.
By implementing the TRIAD surveys, researchers hope to obtain a better understanding of patients' perspectives, knowledge, and decision-making processes regarding the choice between appendectomy and antibiotic treatment for appendicitis. This data can contribute to more informed decision-making and potentially improve outcomes related to antibiotic use for this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Patients who chose to receive surgery as treatment for their appendicitis. |
| |
| Antibiotics | Patients who chose to receive antibiotics as treatment for their appendicitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline | Other | Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ottawa Decisional Conflict Scale | Ottawa Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty; and effective decision making | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient 18+ years old or older who has been diagnosed with appendicitis at a participating TRIAD clinical site after anticipated exclusion due to age, medical condition, or radiographic finding.
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| Name | Affiliation | Role |
|---|---|---|
| Giana Davidson, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Baldwin Park | Baldwin Park | California | 90027 | United States | ||
| Kaiser Permanente Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33017106 | Result | CODA Collaborative; Flum DR, Davidson GH, Monsell SE, Shapiro NI, Odom SR, Sanchez SE, Drake FT, Fischkoff K, Johnson J, Patton JH, Evans H, Cuschieri J, Sabbatini AK, Faine BA, Skeete DA, Liang MK, Sohn V, McGrane K, Kutcher ME, Chung B, Carter DW, Ayoung-Chee P, Chiang W, Rushing A, Steinberg S, Foster CS, Schaetzel SM, Price TP, Mandell KA, Ferrigno L, Salzberg M, DeUgarte DA, Kaji AH, Moran GJ, Saltzman D, Alam HB, Park PK, Kao LS, Thompson CM, Self WH, Yu JT, Wiebusch A, Winchell RJ, Clark S, Krishnadasan A, Fannon E, Lavallee DC, Comstock BA, Bizzell B, Heagerty PJ, Kessler LG, Talan DA. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Nov 12;383(20):1907-1919. doi: 10.1056/NEJMoa2014320. Epub 2020 Oct 5. |
| Label | URL |
|---|---|
| Link to Decision Support Tool and Patient Survey | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Jun 8, 2023 |
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| 30 Day Follow Up | Other | Measure Ottawa Decisional Regret after 30 days. |
|
| Los Angeles |
| California |
| 90027 |
| United States |
| Kaiser Permanente Riverside | Riverside | California | 92555 | United States |
| Grady Health System / Morehouse School of Medicine | Atlanta | Georgia | 30305 | United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Michigan Medicine- University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Lyndon B Johnson- Harris Health | Houston | Texas | 77026 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77026 | United States |
| Texas Tech University | Lubbock | Texas | 79430 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Northwest Hospital and Medical Center | Seattle | Washington | 98133 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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