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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MyChart Questionnaire
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 1

Eligibility Criteria

0 Years - 131 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children's Hospital of Eastern Ontario - Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MyChart Questionnaire (Intervention Group)

Standard Clinical Care (Control Group)

Arm Description

Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire.

Participants within the control group will undergo standard clinical care with no study intervention.

Outcomes

Primary Outcome Measures

To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
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.
Patients' Evaluation of Quality of Diabetes Care (PEQD)
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.
Perceived Quality of Medical Care (PQMC)
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.
Participant Tool and Workflow Survey
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.

Secondary Outcome Measures

To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
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, %).

Full Information

First Posted
April 24, 2023
Last Updated
August 24, 2023
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT05979077
Brief Title
Children's Hospital Academic Medical Organization (CHAMO) MyChart Study
Official Title
Improving Quality of Care in Diabetes Clinic Through Patient-Entered Electronic Health Data?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyChart Questionnaire (Intervention Group)
Arm Type
Experimental
Arm Description
Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire.
Arm Title
Standard Clinical Care (Control Group)
Arm Type
No Intervention
Arm Description
Participants within the control group will undergo standard clinical care with no study intervention.
Intervention Type
Other
Intervention Name(s)
MyChart Questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
Description
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.
Time Frame
12 months
Title
Patients' Evaluation of Quality of Diabetes Care (PEQD)
Description
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.
Time Frame
12 months
Title
Perceived Quality of Medical Care (PQMC)
Description
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.
Time Frame
12 months
Title
Participant Tool and Workflow Survey
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
Description
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, %).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
131 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias Abou-Assaly, BA
Phone
613-737-7600
Ext
6940
Email
eabouassaly@cheo.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Saunya Dover, MSc
Phone
613-737-7600
Ext
4874
Email
sdover@cheo.on.ca
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario - Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias Abou-Assaly, BA
Phone
613-737-7600
Ext
6940
Email
eabouassaly@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Saunya Dover, MSc
Phone
613-737-7600
Ext
4874
Email
sdover@cheo.on.ca

12. IPD Sharing Statement

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

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