Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)

NCT02110485 | Completed Results

• 2 other identifiers: IRB13-003354350
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis; Children

Keywords

Appendicitis; Pediatric; Children; Non-operative; Antibiotics alone

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  1 year folow-up

Secondary Outcomes (3)

• Patient Activation Measure (PAM)

  1 hour

• Number of Participants Readmitted

  1 year

• PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales

  30 day follow-up

Study Arms (2)

Patient Activation Tool

EXPERIMENTAL

Patients and their caregivers will receive the patient activation tool in addition to standard consultation

Other: Patient Activation Tool

Standard Consultation

NO INTERVENTION

Patients and their caregivers will receive standard consultation alone

Interventions

Patient Activation Tool OTHER

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.

Patient Activation Tool

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Positive urine pregnancy test
• Other significant co-morbidities:
• cardiovascular disease
• malignancy
• pulmonary disease
• severe developmental delay

Sponsors & Collaborators

• Peter Minneci: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 26865380 BACKGROUND

• Minneci 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.

  PMID: 31173118 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Results Point of Contact

• Title: Beth Fischer
• Organization: Nationwide Children's Hospital

beth.fischer@nationwidechildrens.org

614-355-0338

Study Officials

• Katherine J Deans, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2019
• Last Updated: November 19, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)