Children's Hospital Academic Medical Organization (CHAMO) MyChart Study

April 13, 2025 updated by: Ellen Goldbloom, Children's Hospital of Eastern Ontario

Improving Quality of Care in Diabetes Clinic Through Patient-Entered Electronic Health Data?

Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. As a result, much of the physician-patient visit is spent transferring information instead of focusing on diabetes care, contributing to increased time pressures in clinic and unmet needs for patients.

In response to this reality, the investigators have developed a tool that allows families to input their diabetes-related information into their physicians' electronic health record (EHR) documentation tool before their clinic visit, using a questionnaire administered via CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes control and clinic efficiency. The investigators hope that our study will determine whether having families input clinical data prior to a visit is an effective strategy to improve the quality of diabetes care. The investigators believe that the findings will be of interest to all those studying the value of incorporating patient-entered data both within diabetes care and beyond.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario - Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of T1D
  • Age <11 years at enrollment

Exclusion Criteria:

  • Patients ≥ 11 years of age at enrollment
  • Patients who are not fluent enough in English to complete all study related procedures
  • Patients unable or unwilling to provide consent and/or assent
  • Patients followed in Eating Disorder Clinic or Child and Youth Protection Clinic (there are MyChart activation restrictions for individuals followed in these clinics)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MyChart Questionnaire (Intervention Group)
Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire.
Other: MyChart Questionnaire
Prior to clinic visits, families completing the MyChart Questionnaire will enter details about their current management and visit goals, automatically populating their electronic health record for subsequent review/revision by the health care team before and during the visit, reallocating clinic time previously used for data acquisition to individual patient priorities
No Intervention: Standard Clinical Care (Control Group)
Participants within the control group will undergo standard clinical care with no study intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
Time Frame: 12 months
The EHR-enabled questionnaire will be completed through the online MyChart portal. Patients' parents are required to complete diabetes-related questions across a total of 10 pages, including questions regarding the visit, insulin dosing, injection dose, insulin delivery, blood sugar monitoring, high blood glucose and ketones, hypoglycemia, nutrition, physical activity, and general health. These questions are typically addressed during routine clinic visits; however, they will be completed prior to the clinic visit and automatically entered into the patient's medical chart.
12 months
Patients' Evaluation of Quality of Diabetes Care (PEQD)
Time Frame: 12 months
The PEQD is a brief and validated questionnaire designed to assess the participants' judgement about the quality of their diabetes care. It is scored on a scale of 0-100 with 100 representing the best possible quality of care.
12 months
Perceived Quality of Medical Care (PQMC)
Time Frame: 12 months
The PQMC is a validated instrument designed to provide a simple, general measure of patients' overall quality of medical care they receive. Alpha reliability estimates should be expected to be above .90 for this instrument. It is scored on a scale from 6-42, with lower scores representing better perceived quality of medical care.
12 months
Participant Tool and Workflow Survey
Time Frame: 12 months
This study-specific questionnaire was developed during pilot work for this study and was designed to specifically assess the myChart questionnaire being completed before each clinic visit. This questionnaire will only be given to those participants randomized to the intervention group. While this questionnaire has not been validated, it has been used in previously published research by our study team.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
Time Frame: 12 months
Changes in glycemic control will be obtained from the patient's medical chart. Glycemic control will include: hemoglobin A1c (HbA1c, (%)), percent time in range (TIR - percentage of time in previous 14 days spent within target glucose range of 70-180 mg/dL or 3.9-10 mmol/L), and glucose management indicator (GMI, %).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Eastern Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/99X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on MyChart Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings