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This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.
The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cost Information Included | Experimental | Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. |
|
| No Cost Information Included | No Intervention | Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cost Information Included | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Choice Based on Cost | The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information | Outcome assessed prior to surgical procedure with data presented within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital/Operative Dollars | A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups | Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Scaife, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25185471 | Derived | Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cost Information Included | Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Cost Information Included |
| FG001 | No Cost Information Included | Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age, Gender
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| ID | Title | Description |
|---|---|---|
| BG000 | Cost Information Included | Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Cost Information Included |
| BG001 | No Cost Information Included |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Choice Based on Cost | The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information | Posted | Number | percentage of open appendectomy | Outcome assessed prior to surgical procedure with data presented within 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cost Information Included | Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Cost Information Included |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Scaife | University of Utah | 801-662-2950 | eric.scaife@imail2.org |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Hospital/Operative Dollars | A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups | Posted | Median | Inter-Quartile Range | Dollar | Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | No Cost Information Included | Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. | 0 | 51 | 0 | 51 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |