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Clinical Trials/NCT05979077
NCT05979077
Active, not recruiting
Not Applicable

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

Children's Hospital of Eastern Ontario1 site in 1 country200 target enrollmentApril 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
Children's Hospital of Eastern Ontario
Enrollment
200
Locations
1
Primary Endpoint
Patients' Evaluation of Quality of Diabetes Care (PEQD)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2023
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ellen Goldbloom

Pedatric Endocrinologist

Children's Hospital of Eastern Ontario

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)

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.(12 months)

Study Sites (1)

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