Colorectal DisordersRLHSNCT03131180
Rapid Learning Healthcare System in Pediatric Surgery
A study testing Rapid Learning Healthcare System in people with Colorectal Disorders, run by Katherine Deans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Rapid Learning Healthcare System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Patients previously treated at CCPR, those who are non-English speaking, and those without internet access.
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: 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.
Read the 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.
- Conditions
- Colorectal Disorders
- Being tested
- Rapid Learning Healthcare System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Learning Healthcare SystemOther
Also called Interactive Patient Education Dashboard
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rapid Learning Healthcare System |
| Standard consultation alone | No intervention | Those not randomized to RLHS access undergo standard consultation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post-enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jul 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katherine Deans
- Sponsor type
- University, hospital or other
- Collaborators
- Society of University Surgeons
- Responsible party
- Sponsor-investigator, Katherine Deans, Nationwide Children's Hospital
- Investigators
- Katherine Deans, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131180
- Sponsor's protocol ID
- IRB16-00537
- Acronym
- RLHS
- Status last verified
- Nov 2018
- First submitted
- 19 Apr 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Rapid Learning Healthcare System in Pediatric Surgery
- ClinicalTrials.gov ID
- NCT03131180
- Acronym / sponsor ID
- RLHS / IRB16-00537
- Conditions
- Colorectal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Katherine DeansUniversity, hospital or other
- Collaborators
- Society of University Surgeons
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RLHS dashboard | Experimental | Other: Rapid Learning Healthcare SystemPatients 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. |
| Standard consultation alone | No intervention | –Those not randomized to RLHS access undergo standard consultation only. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients previously treated at CCPR, those who are non-English speaking, and those without internet access.
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 |
|---|---|---|
| Rapid Learning Healthcare SystemAlso: Interactive Patient Education DashboardThe 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 | RLHS dashboard |
Primary outcome
Improved healthcare satisfaction
Time frame: 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
2 secondary outcomes
Improved patient-centered outcomes
Time frame: 30 days post-enrollment
Usability of RLHS
Time frame: 30 days post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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 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 Rapid Learning Healthcare System in people with Colorectal Disorders, run by Katherine Deans 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 1 inclusion and 1 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 28 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved healthcare satisfaction (time frame: 30 days post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2018.