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

NCT ID: NCT03084900

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2021-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient-Centered Decision Support

Intervention - computer decision support in diabetes clinic. Investigators 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.

Group Type: EXPERIMENTAL

Arm 1

Intervention Type: 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.

Standard Care

Standard pediatric diabetes care will be compared to the computerized decision support system.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Arm 1

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adolescents with type 1 diabetes

2. Parents of adolescents with type 1 diabetes

3. Friends/siblings of adolescents with type 1 diabetes

4. Community partners who work with adolescents with type 1 diabetes

5. Diabetes care providers

-

Exclusion Criteria

-

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tamara S. Hannon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara Hannon, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1DP3DK113183-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1612394802

Identifier Type: -

Identifier Source: org_study_id