Appendicitis
Conditions
Keywords
surgical choice, cost of care, decision making, health care, health care cost, pediatric, children, appendicitis, patient satisfaction
Brief summary
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.
Interventions
OTHERCost Information Included
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* acute appendicitis
Exclusion criteria
* age 18 or older * imaging positive for perforation; ultrasound or CT scan * pain for greater than 2 days * children with a body mass index \> 95% for age and sex * surgeon decision for non-equivalent procedure based on patient presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Choice Based on Cost | Outcome assessed prior to surgical procedure with data presented within 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital/Operative Dollars | Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year | A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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. | 51 |
| Total | 100 |
Baseline characteristics
| Characteristic | Cost Information Included | No Cost Information Included | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 51 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.8 years STANDARD_DEVIATION 3.3 | 10.6 years STANDARD_DEVIATION 3.2 | 10.7 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 49 participants | 51 participants | 100 participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 27 Participants | 31 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
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
Time frame: Outcome assessed prior to surgical procedure with data presented within 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cost Information Included | Choice Based on Cost | 63 percentage of open appendectomy |
| No Cost Information Included | Choice Based on Cost | 35 percentage of open appendectomy |
Secondary
Hospital/Operative Dollars
A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups
Time frame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cost Information Included | Hospital/Operative Dollars | 9,949 Dollar |
| No Cost Information Included | Hospital/Operative Dollars | 10,477 Dollar |