Rapid Learning Healthcare System in Pediatric Surgery

Not Applicable

Completed

• Conditions: Colorectal Disorders

• Registration Number: NCT03131180
• Lead Sponsor: Katherine Deans

Brief Summary

Engaging patients and families to take an active role in their healthcare leads to improved outcomes. Providing physicians and families with near real-time data on outcomes in children with similar medical conditions can allow families to form realistic expectations and take an active role in their child's health. It also provides physicians with near real-time feedback on patient-reported outcome measures to guide both conversations and recommendations for therapy at the point-of-care.

A rapid learning healthcare system (RLHS) is a system that merges clinical research and clinical care. It is designed to collect data during routine patient care and then utilize the data to rapidly generate evidence to improve patient care, provide information to patients and families, and track quality measures.

The investigators created a RLHS that integrates pre-specified data elements and validated surveys within the clinical workflow in order to operationalize automated research data collection and integrate predictive analytics into the electronic health record (EHR). Patients, caregivers, and physicians can access data in order to make informed, shared decisions about care and align expectations about outcomes.

Detailed Description

Functional disabilities such as functional constipation, and congenital anomalies such as anorectal malformations (ARM) and Hirschsprung disease (HD), are the leading indications for colon surgery in children. While these diseases have low mortality rates and surgical techniques can effectively restore anatomy, these patients have persistent and significant post-operative morbidity around fecal soiling and/or constipation. In addition to impairing growth and development, this affects all domains of health related quality of life (HRQoL). Patients, families, and healthcare providers of children with these diseases consistently report that bowel management strategies that prevent soiling comprise one of the most important areas for high quality outcomes research.

Engaging patients and families to take an active role in their healthcare leads to improved outcomes. Providing physicians and families with near real-time data on outcomes in children with similar medical conditions can allow families to form realistic expectations and take an active role in their child's health. It also provides physicians with near real-time feedback on patient-reported outcome measures to guide both conversations and recommendations for therapy at the point-of-care. A rapid learning healthcare system (RLHS) is a system that merges clinical research and clinical care. It is designed to collect data during routine patient care and then utilize the data to rapidly generate evidence to improve patient care, provide information to patients and families, and track quality measures.

The investigators created a RLHS that integrates pre-specified data elements and validated surveys within the clinical workflow in order to operationalize automated research data collection and integrate predictive analytics into the electronic health record (EHR). To date, we have over 800 patients enrolled in the colorectal RLHS. Patients, caregivers, and physicians can access data in order to make informed, shared decisions about care and align expectations about outcomes.

The primary and secondary objective of this trial are as follows:

Primary Objective: To assess the ability of a RLHS to improve healthcare satisfaction in pediatric patients with complex colorectal diseases.

Secondary Objective: To assess the ability of a RLHS to improve patient-centered outcomes in pediatric patients with complex colorectal diseases.To characterize the usability of the RLHS by patients and caregivers.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• English speaking patients aged 0-17 years with a diagnosis of ARM, HD, or functional constipation referred to our CCPR clinic between July 1, 2016 through June 1, 2017.

Exclusion Criteria

• Patients previously treated at CCPR, those who are non-English speaking, and those without internet access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improved healthcare satisfaction	30 days post-enrollment	To assess the ability of a RLHS to improve healthcare satisfaction in pediatric patients with complex colorectal diseases. As measured by the PedsQL Healthcare Satisfaction questionnaire

Secondary Outcome Measures

Name	Time	Method
Improved patient-centered outcomes	30 days post-enrollment	To assess the ability of a RLHS to improve patient-centered outcomes in pediatric patients with complex colorectal diseases. As measured by the PedsQL Quality of Life questionnaire designed for both parents and children.
Usability of RLHS	30 days post-enrollment	To characterize the usability of the RLHS by patients and caregivers. As measured by the System Usability Scale designed by the investigators.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States