Rapid Learning Healthcare System in Pediatric Surgery (RLHS)

Randomized Controlled Trial: Rapid Learning Healthcare System in Pediatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Disorders
• Intervention / Treatment: Other: Rapid Learning Healthcare System

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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RLHS dashboard; Patients randomized to RLHS website access are given instructions on how the RLHS dashboard works both by phone and by email and are given open access to the RLHS dashboard website immediately after enrollment and before meeting with the CCPR clinical team for their consultation. Each user has an access code, which allows them to track their access. They maintain access to the website throughout their care in the CCPR. Patients in the RLHS access group complete the System Usability Scale (SUS; a 10 item questionnaire to evaluate software, websites, and applications) after use of the RLHS at consultation. Those in the RLHS access group also complete a 7-item exit interview either via phone or on REDCap.	Other: Rapid Learning Healthcare System; The investigators created a Rapid Learning Healthcare System 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 access data in order to make informed, shared decisions about care and align expectations about outcomes.; Other Names: Interactive Patient Education Dashboard
NO_INTERVENTION: Standard consultation alone; Those not randomized to RLHS access undergo standard consultation only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved healthcare satisfaction	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	30 days post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved patient-centered outcomes	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.	30 days post-enrollment
Usability of RLHS	To characterize the usability of the RLHS by patients and caregivers. As measured by the System Usability Scale designed by the investigators.	30 days post-enrollment

Collaborators and Investigators

• Sponsor: Katherine Deans
• Collaborators: Society of University Surgeons
• Investigators: Principal Investigator: Katherine Deans, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB16-00537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No