AppendicitisAppy-PATNCT02110485
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)
A study testing Patient Activation Tool in people with Appendicitis and Children, run by Peter Minneci at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Appendicitis, Children
- What is being tested?
- Patient Activation Tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Positive urine pregnancy test
- Other significant co-morbidities:
- cardiovascular disease
- malignancy
- pulmonary disease
- severe developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy
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.
Read the 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).
- Conditions
- Appendicitis, Children
- Being tested
- Patient Activation Tool
- Keywords
- Appendicitis, Pediatric, Children, Non-operative, Antibiotics alone
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Activation ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Activation Tool | Experimental | Patients and their caregivers will receive the patient activation tool in addition to standard consultation Receives: Other: Patient Activation Tool |
| Standard Consultation | No intervention | Patients and their caregivers will receive standard consultation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour following decision
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
Measured: 1 day from enrollment
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.
Measured: 1 year folow-up
Secondary outcomes (3)
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.
Measured: 1 hour
Number of Participants Readmitted
Readmissions rates to any hospital within 1 year wil be assessed
Measured: 1 year
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
Measured: 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study start1 Mar 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Minneci
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Peter Minneci, Nationwide Children's Hospital
- Investigators
- Katherine J Deans, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110485
- Sponsor's protocol ID
- IRB13-00335
- Other IDs
- 4350
- Acronym
- Appy-PAT
- Status last verified
- Nov 2019
- First submitted
- 10 Mar 2014
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Minneci PC, Nacion KM, Lodwick DL, Cooper JN, Deans KJ. Improving Surgical Research by Involving Stakeholders. JAMA Surg. 2016 Jun 1;151(6):579-80. doi: 10.1001/jamasurg.2015.4898. No abstract available.
PubMed 26865380Minneci PC, Cooper JN, Leonhart K, Nacion K, Sulkowski J, Porter K, Wei L, Deans KJ. Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195009. doi: 10.1001/jamanetworkopen.2019.5009.
PubMed 31173118
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy
- ClinicalTrials.gov ID
- NCT02110485
- Acronym / sponsor ID
- Appy-PAT / IRB13-00335
- Conditions
- Appendicitis, Children
- Keywords
- Appendicitis, Pediatric, Children, Non-operative, Antibiotics alone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peter MinneciUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Activation Tool | Experimental | Other: Patient Activation ToolPatients and their caregivers will receive the patient activation tool in addition to standard consultation |
| Standard Consultation | No intervention | –Patients and their caregivers will receive standard consultation alone |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age : 7-17 years
- Ultrasound (US) or Computed Tomography (CT) confirmed early appendicitis:
- White Blood Cell count < 18,000
- C-reactive Protein<4 (if obtained)
- Focal abdominal pain </= 48 hours prior to receiving antibiotics
Key exclusion criteria (6 listed)
- Positive urine pregnancy test
- Other significant co-morbidities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Activation ToolAn 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. | Other | Patient Activation Tool |
Primary outcome
Decision Self-Efficacy Scale
Time frame: 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)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Patient Activation Measure (PAM)
Time frame: 1 hour
Number of Participants Readmitted
Time frame: 1 year
PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales
Time frame: 30 day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26865380Minneci PC, Nacion KM, Lodwick DL, Cooper JN, Deans KJ. Improving Surgical Research by Involving Stakeholders. JAMA Surg. 2016 Jun 1;151(6):579-80. doi: 10.1001/jamasurg.2015.4898. No abstract available.
- Derived from this study: PubMed 31173118Minneci PC, Cooper JN, Leonhart K, Nacion K, Sulkowski J, Porter K, Wei L, Deans KJ. Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195009. doi: 10.1001/jamanetworkopen.2019.5009.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine J Deans, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Activation Tool in people with Appendicitis and Children, run by Peter Minneci at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Self-Efficacy Scale (time frame: 1 hour following decision). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.