Rapid Learning Healthcare System in Pediatric Surgery

NCT03131180 | Completed

• 1 other identifier: IRB16-00537
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improved patient-centered outcomes

  30 days post-enrollment

• Usability of RLHS

  30 days post-enrollment

Study Arms (2)

RLHS dashboard

EXPERIMENTAL

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

Standard consultation alone

NO INTERVENTION

Those not randomized to RLHS access undergo standard consultation only.

Interventions

Rapid Learning Healthcare System OTHER

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.

Also known as: Interactive Patient Education Dashboard

RLHS dashboard

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Katherine Deans: lead
• Society of University Surgeons: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Katherine Deans, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Surgical Outcomes Research, Nationwide Children's Hospital; Assistant Professor of Surgery, The Ohio State University

Model Details: This trial is a single center randomized controlled trial to investigate the ability of the RLHS to improve patient-centered outcomes in pediatric patients with complex colorectal diseases. Patients and caregivers are randomized to either receive access to a website that displays the colorectal RLHS dashboard prior to standard consultation or to standard consultation alone.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 27, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)