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Clinical Trials/NCT03475108
NCT03475108
Completed
N/A

Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes

Children's Hospital of Philadelphia1 site in 1 country84 target enrollmentApril 19, 2018

Overview

Phase
N/A
Intervention
Community Health Worker added to diabetes team
Conditions
Type 1 Diabetes Mellitus
Sponsor
Children's Hospital of Philadelphia
Enrollment
84
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.

Detailed Description

Diabetic ketoacidosis accounts for 65% of hospitalizations in pediatric patients with type 1 diabetes, and has a mortality rate between 0.15-0.31%. Children with established type 1 diabetes have an 8% annualized risk of developing diabetic ketoacidosis, and this risk increases during adolescence. In addition, socioeconomic and racial disparities are associated with increased risks of poor glycemic control, hospitalization with diabetic ketoacidosis, and even severe hypoglycemia. All of these complications are associated with preventable harm, and lead to increased utilization of medical resources, both in the short- and long-term. Social determinants of health account for over 75% of health outcomes. Thus, it is not surprising that a disproportionate number of children with poor diabetes control and recurrent hospitalization in diabetic ketoacidosis come from vulnerable underserved populations. In this study, Investigators will study the effect of integrating a community-based healthcare worker into the healthcare team of children with poorly controlled type 1 diabetes. Community Health Workers (CHW) are highly motivated, community members who do not necessarily have prior medical training, but rather they link with the healthcare team to identify and provide relevant social supports to the family. They receive specific training that focuses on issues relevant to improving health outcomes and adherence, by improving medication access, reducing food insecurity, and improving health literacy. The CHW are able to provide real-time assistance with navigating the healthcare and social services systems, reducing family stress and breaking down community barriers to positive health behavior. The CHW work with the family to develop goals and develop an individualized plan to reach these goals. The role of the CHW can include home visits, phone contacts, meeting with school representatives and accompanying patients to appointments. At the diabetes center at The Children's Hospital of Philadelphia (CHOP), the Community Health Worker will be assigned for one year to patients with high healthcare utilization and / or poorly controlled type 1 diabetes. The support provided for this year will be tailored to the patient's needs but may include problem solving surrounding issues related to work/education, accessing healthcare/medications, engagement with the healthcare team, transportation, housing or food insecurity. Interactions with patients will be through home visits, telephone encounters, text messaging or email. This will be added to their medical care and will be documented in the patient's medical record.

Registry
clinicaltrials.gov
Start Date
April 19, 2018
End Date
March 10, 2021
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A clinical diagnosis of type 1 diabetes for \> 1 year
  • Over the previous one year, the sum of the following should be \> 2: diabetes-related hospitalizations plus emergency department visits plus missed appointments (on separate days) or Hemoglobin A1c ≥ 9.5 at the time of enrollment.

Exclusion Criteria

  • Children in custody of the State where there is no identified caretaker who can complete study procedures

Arms & Interventions

Community Health Worker Group

Patients are assigned a community health worker for one year, in addition to standard diabetes care. They do not receive a community health worker for the second year of the study.

Intervention: Community Health Worker added to diabetes team

Standard Diabetes Care Group

Patients receive standard diabetes care for one year. They receive a community health worker for the second year (as part of a crossover trial).

Intervention: Community Health Worker added to diabetes team

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 2 years

Improvement in glycemic control, as measured by hemoglobin A1c

Secondary Outcomes

  • Emergency Department utilization(2 years)
  • Attended outpatient appointments(2 years)
  • Missed outpatient appointments(2 years)
  • Quality of life (primary care giver)(2 years)
  • Hospital admissions(2 years)
  • Primary caregiver's diabetes self-efficacy(2 years)

Study Sites (1)

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