Appendicitis, Children
Conditions
Keywords
Appendicitis, Pediatric, Children, Non-operative, Antibiotics alone
Brief summary
The purpose of this study is to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers choosing between antibiotics alone and appendectomy.
Detailed description
The objective of this study is to to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers. Hypothesis: A PAT that activates patient-caregiver dyads will improve decision making and patient centered outcomes without compromising medical outcomes in children with appendicitis. Specifically,the investigators expect the PAT to improve decision self-efficacy and healthcare satisfaction without increasing disability days. Methods/Outcomes: The investigators will perform a randomized controlled trial comparing a PAT to standard surgical consultation in patient-caregiver dyads choosing between either antibiotics alone or appendectomy for early appendicitis. The investigators will identify differences in various components of decision making and patient centered outcomes including caregiver decision self-efficacy, preparedness for decision making, decisional conflict, decision regret, caregiver activation, caregiver and child satisfaction with care and health related quality of life (HRQOL), and caregiver and child knowledge. The investigators will also characterize the effects of a PAT on medical outcomes from appendicitis in patients receiving the PAT compared to those receiving standard surgical consultation alone. The investigators will determine differences in disability days, length of stay, readmission rates, and medical complications related to treatment choice (e.g. infection, recurrence).
Interventions
OTHERPatient Activation Tool
An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.
Sponsors
Patient-Centered Outcomes Research Institute
Peter Minneci
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age : 7-17 years * Ultrasound (US) or Computed Tomography (CT) confirmed early appendicitis: * US: hyperemia, \<1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon * CT: hyperemia, fat stranding, \<1.1 cm in diameter, no abscess, no fecalith, no phlegmon * White Blood Cell count \< 18,000 * C-reactive Protein\<4 (if obtained) * Focal abdominal pain \</= 48 hours prior to receiving antibiotics
Exclusion criteria
* Positive urine pregnancy test * Other significant co-morbidities: * cardiovascular disease * malignancy * pulmonary disease * severe developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Self-Efficacy Scale | 1 hour following decision | Decision Self-Efficacy will be measured using the Decision Self-Efficacy Scale which measures the participant's confidence in their ability to make decisions and consists of 11 questions regarding different aspects of decision making. This will be measured 1 hour after treatment decision has been made. The scale is a 5 point scale ranging from 0-not at all confident to 4-very confident. Higher scores are better. Scoring includes summing all items, dividing by 11; and multiplying by 25. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy |
| PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) | 1 day from enrollment | Healthcare satisfaction will be measured at the time of discharge (average 1-2 days) using the PedsQL 3.0 Healthcare Satisfaction Generic Module- Parent Report. This survey measures the parent's satisfaction with the care their child received and measures six dimensions (information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction) using 24 items. Parents chose a score from 0-4; 0=never happy; 1=sometimes happy; 2=often happy; 3=almost always happy; 4=always happy, followed by the ability to respond not applicable Subscale scores are not reported If not applicable is chosen, the item is not scored nor included n the final sum. Scoring is based on a total sum for all items as well as a subscale sum for each of the 6 dimensions. Higher scores are better. Total scores range from 0-96 |
| Disability Days | 1 year folow-up | Disability days will be assessed at 1 year follow-up. Disability days is a composite of inpatient hospital days, emergency department visits, primary care physician visits and all days with limited activities referable to their appendicitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) | 1 hour | Parent activation will be assessed with the Patient Activation Measure® (Parent-PAM®) using a version of healthy child parent PAM® adapted with permission. This 13 item scale and was derived from the short form version of the Patient Activation Measure®. The Parent-PAM® is used to assess the parent's activation in the management of their child's health. The 13 items have response options ranging from 1=strongly disagree to 4 strongly agree with an option to respond as not applicable. A total PAM score is calculated by summing all items and dividing by the number of items answered and multiplied by 13; total scores can range from 13-52. This score is transformed to a scale ranging from 0-100 with higher PAM scores indicating higher patient activation. |
| Number of Participants Readmitted | 1 year | Readmissions rates to any hospital within 1 year wil be assessed |
| PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales | 30 day follow-up | The PedsQL Pediatric Quality of Life Inventory is a 23 item survey with response options offered on a 5 point scale; 0= never been a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. A total score is summed for each of the 4 dimensions as well as an overall score for the entire measure. The PedsQL Family Impact Module Scales include subscales: physical functioning; emotional functioning; social functioning; cognitive functioning; communication; worry; family functioning; daily activities; and family relationships. The options for this 5-point scale range from 0= never a problem to 4=always a problem). Items are reverse-scored and high scores indicate better family functioning. A total summed score is utilized. Each subscale can be summed individually and divided by the number of items in that. Total scores for this measure range from 0-92 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Activation Tool Patients and their caregivers will receive the patient activation tool in addition to standard consultation
Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision. | 98 |
| Standard Consultation Patients and their caregivers will receive standard consultation alone | 102 |
| Total | 200 |
Baseline characteristics
| Characteristic | Patient Activation Tool | Standard Consultation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 98 Participants | 102 Participants | 200 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 | 12 years | 13 years | 12 years |
| Insurance Status Medicaid | 37 Participants | 28 Participants | 65 Participants |
| Insurance Status No insurance | 2 Participants | 7 Participants | 9 Participants |
| Insurance Status Private Insurance | 59 Participants | 67 Participants | 126 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) White | 88 Participants | 85 Participants | 173 Participants |
| Region of Enrollment United States | 98 Participants | 102 Participants | 200 Participants |
| Sex: Female, Male Female | 39 Participants | 41 Participants | 80 Participants |
| Sex: Female, Male Male | 59 Participants | 61 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 102 |
| other Total, other adverse events | 0 / 98 | 0 / 102 |
| serious Total, serious adverse events | 0 / 98 | 0 / 102 |
Outcome results
Primary
Decision Self-Efficacy Scale
Decision Self-Efficacy will be measured using the Decision Self-Efficacy Scale which measures the participant's confidence in their ability to make decisions and consists of 11 questions regarding different aspects of decision making. This will be measured 1 hour after treatment decision has been made. The scale is a 5 point scale ranging from 0-not at all confident to 4-very confident. Higher scores are better. Scoring includes summing all items, dividing by 11; and multiplying by 25. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy
Time frame: 1 hour following decision
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Activation Tool | Decision Self-Efficacy Scale | 100 units on a scale |
| Standard Consultation | Decision Self-Efficacy Scale | 100 units on a scale |
p-value: 0.03Wilcoxon (Mann-Whitney)
Primary
Disability Days
Disability days will be assessed at 1 year follow-up. Disability days is a composite of inpatient hospital days, emergency department visits, primary care physician visits and all days with limited activities referable to their appendicitis.
Time frame: 1 year folow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Activation Tool | Disability Days | 5 Days |
| Standard Consultation | Disability Days | 6 Days |
p-value: 0.67Wilcoxon (Mann-Whitney)
Primary
PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)
Healthcare satisfaction will be measured at the time of discharge (average 1-2 days) using the PedsQL 3.0 Healthcare Satisfaction Generic Module- Parent Report. This survey measures the parent's satisfaction with the care their child received and measures six dimensions (information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction) using 24 items. Parents chose a score from 0-4; 0=never happy; 1=sometimes happy; 2=often happy; 3=almost always happy; 4=always happy, followed by the ability to respond not applicable Subscale scores are not reported If not applicable is chosen, the item is not scored nor included n the final sum. Scoring is based on a total sum for all items as well as a subscale sum for each of the 6 dimensions. Higher scores are better. Total scores range from 0-96
Time frame: 1 day from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Activation Tool | PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) | 98.3 units on a scale |
| Standard Consultation | PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) | 99.0 units on a scale |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Readmitted
Readmissions rates to any hospital within 1 year wil be assessed
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Activation Tool | Number of Participants Readmitted | 15 Participants |
| Standard Consultation | Number of Participants Readmitted | 15 Participants |
p-value: 0.84Fisher Exact
Secondary
Patient Activation Measure (PAM)
Parent activation will be assessed with the Patient Activation Measure® (Parent-PAM®) using a version of healthy child parent PAM® adapted with permission. This 13 item scale and was derived from the short form version of the Patient Activation Measure®. The Parent-PAM® is used to assess the parent's activation in the management of their child's health. The 13 items have response options ranging from 1=strongly disagree to 4 strongly agree with an option to respond as not applicable. A total PAM score is calculated by summing all items and dividing by the number of items answered and multiplied by 13; total scores can range from 13-52. This score is transformed to a scale ranging from 0-100 with higher PAM scores indicating higher patient activation.
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Activation Tool | Patient Activation Measure (PAM) | 91 units on a scale |
| Standard Consultation | Patient Activation Measure (PAM) | 100 units on a scale |
p-value: 0.17Wilcoxon (Mann-Whitney)
Secondary
PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales
The PedsQL Pediatric Quality of Life Inventory is a 23 item survey with response options offered on a 5 point scale; 0= never been a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. A total score is summed for each of the 4 dimensions as well as an overall score for the entire measure. The PedsQL Family Impact Module Scales include subscales: physical functioning; emotional functioning; social functioning; cognitive functioning; communication; worry; family functioning; daily activities; and family relationships. The options for this 5-point scale range from 0= never a problem to 4=always a problem). Items are reverse-scored and high scores indicate better family functioning. A total summed score is utilized. Each subscale can be summed individually and divided by the number of items in that. Total scores for this measure range from 0-92
Time frame: 30 day follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Activation Tool | PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales | 88.0 units on a scale |
| Standard Consultation | PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales | 88.0 units on a scale |
p-value: 0.99Wilcoxon (Mann-Whitney)