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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Psychosocial Problem Compliance, Patient Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Crossover Trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Community Health Worker added to diabetes team

Intervention Type OTHER

A Community Health Worker will be added to the diabetes team caring for a child with type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

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).

Group Type OTHER

Community Health Worker added to diabetes team

Intervention Type OTHER

A Community Health Worker will be added to the diabetes team caring for a child with type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

Interventions

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Community Health Worker added to diabetes team

A Community Health Worker will be added to the diabetes team caring for a child with type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A clinical diagnosis of type 1 diabetes for \> 1 year
* Either:

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.