Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03475108|
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Psychosocial Problem Compliance, Patient Diabetes Mellitus||Other: Community Health Worker added to diabetes team||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes|
|Actual Study Start Date :||April 19, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Community Health Worker Group
Patients are assigned a community health worker for one year, in addition to standard diabetes care.
Other: 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.
No Intervention: Standard Diabetes Care Group
Patients receive standard diabetes care.
- Hemoglobin A1c [ Time Frame: 2 years ]Improvement in glycemic control, as measured by hemoglobin A1c
- Hospital admissions [ Time Frame: 2 years ]Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
- Attended outpatient appointments [ Time Frame: 2 years ]Data will be extracted from the medical record of each patient to obtain information on the number of attended outpatient appointments.
- Missed outpatient appointments [ Time Frame: 2 years ]Data will be extracted from the medical record of each patient to obtain information on the number of missed outpatient appointments.
- Emergency Department utilization [ Time Frame: 2 years ]Data will be extracted from the medical record of each patient to obtain information about the number of Emergency Department (ED) visits.
- Primary caregiver's diabetes self-efficacy [ Time Frame: 2 years ]The 17-item, "Parental self efficacy in diabetes scale" will be completed by the primary caregiver using a 5-point Likert rating scale. The questionnaire will provide information to assess glycemic control, and sub analysis of results related to diabetes management, problem solving and teaching. This scale ranges in score from 17 to 85, with higher scores consistent with increased self-efficacy.
- Quality of life (primary care giver) [ Time Frame: 2 years ]The primary care giver will complete the 36-item "PedsQL Health related quality of life for parents of children with chronic disease" questionnaire (HCCQ) using a 5-point Likert rating scale to assess how their child's illness has had an impact on their quality of life. This scale ranges in score from 0 to 144, with higher scores consistent with decreased quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475108
|Contact: Colin P Hawkes, MD PhDfirstname.lastname@example.org|
|Contact: Terri H Lipman, CRNP PhDemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Colin Hawkes, MD PhD 215-590-3174 firstname.lastname@example.org|
|Principal Investigator:||Colin P Hawkes, MD PhD||Children's Hospital of Philadelphia|