NCT05979077

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

April 24, 2023

Last Update Submit

April 13, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    12 months

  • 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.

    12 months

  • 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.

    12 months

  • 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.

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (2)

MyChart Questionnaire (Intervention Group)

EXPERIMENTAL

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

Other: MyChart Questionnaire

Standard Clinical Care (Control Group)

NO INTERVENTION

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

Interventions

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

MyChart Questionnaire (Intervention Group)

Eligibility Criteria

Age0 Years - 131 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of T1D
  • Age \<11 years at enrollment

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario - Research Institute

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pedatric Endocrinologist

Study Record Dates

First Submitted

April 24, 2023

First Posted

August 7, 2023

Study Start

April 3, 2023

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations