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Completed

NCT Number: NCT03084900

Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

About this study

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes. Computer decision support systems (CDSS) have scientifically demonstrated advantages for improving care, and the potential to revolutionize diabetes care because they allow for increased reactive and proactive contact with the health care team, real-time adherence support, and intensification of treatment. In this study,investigators will implement the ADA recommended standards of care using a CDSS developed by the research group - the Child Health Improvement through Computer Automation (CHICA) system.9 One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources, in this case the ADA, in a format that integrates easily into routine care. A second strength of the CHICA system is its ability to screen for patient-centered concerns, including barriers to optimal care such as literacy, socioeconomic issues (i.e., food insecurity, housing insecurity, etc.), and mental health issues (i.e., depression). The provider is alerted, and safety mechanisms are set in motion (i.e., referral to mental health provider, etc.) to address identified issues. In order to ensure that we design the most effective CDSS intervention possible, the study team, in collaboration with the Patient Engagement Core (PEC) of the Indiana Clinical and Translational Science Institute, will partner with adolescents, parents, and other stakeholders in a way that exceeds standard expectations for the engagement of these parties in research. Investigators have experience working directly with patients to elucidate patient-centered outcomes, identify determinants of adherence, and to co-design interventions that are inherently more patient-centered.10-14 By combining a patient-centered design approach along with CDSS investigators will be able to individually tailor recommendations to meet the real needs of patients, taking into account the adolescent patient's perspective and input. This truly innovative approach will offer improved technology-based support systems for diabetes management along with attention to patient-centered goals using co-designed interventions for diabetes self-management.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescents with type 1 diabetes
  • Parents of adolescents with type 1 diabetes
  • Friends/siblings of adolescents with type 1 diabetes
  • Community partners who work with adolescents with type 1 diabetes
  • Diabetes care providers

-

Exclusion criteria

-

Treatment and study plan

Arm 1

Other

Patient-Centered Decision Support to Improve Diabetes Mgmt. We will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures.The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.

Primary outcomes

  1. HbA1c value

    Time frame: 4 years

    Measure of HbA1c value for youth subjects

Secondary outcomes

  1. Hypoglycemia

    Time frame: 4 years

    Number of episodes of hypoglycemia during study

  2. DKA

    Time frame: 4 years

    Number of episodes of DKA during study

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: CHICAT1

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2017
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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