Clinical trial NCT04190368: Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
Official title: Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Middle School and High School Adolescents and Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Adolescents
Young Adults
Group Medical Visits
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Cedars-Sinai Medical Center
First posted: 2019-12-09
Enrollment: 79
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.

Groups:

1. Standard Care - No Group
2. Standard Care - Virtual Team Clinic Group
3. Team Clinic Care - No Group
4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)

   * Patients and parents will attend their own online session

Detailed description: Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.

Eligibility criteria: Inclusion

1. Diagnosis of type 1 diabetes \> 6 month duration
2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
3. Not currently participating in other group interventions
4. English speaking

Exclusions

1. Severe behavioral or developmental disabilities in parent or child
2. Severe psychological diagnoses in parent or child that would make group participation difficult
3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
4. Non-English speaking

Primary outcomes:
measure: Hemoglobin A1C at Baseline
timeFrame: baseline to 12 months
measure: Hemoglobin A1C Progression
timeFrame: At baseline (0), 3 months, 6 months, 9 months, 12 months
measure: Number of Team Clinic Care cohort participants attending appointments
timeFrame: 12 months
measure: Number of Virtual Team Clinic Care cohort participants completing appointments
timeFrame: 12 months
measure: Number of Team Clinic Care cohort participants completing appointments
timeFrame: 12 months
measure: Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire
timeFrame: 12 months
measure: Patient and Provider/Staff Satisfaction
timeFrame: 12 months
measure: Patient Experience
timeFrame: 12 months
measure: Social Determinants of Health Tool
timeFrame: At 0 (baseline)
measure: Number of Standard Clinic cohort participants completing appointments
timeFrame: 12 months
measure: Number of Standard Care cohort participants completing appointments
timeFrame: 12 months
Secondary outcomes:
measure: Number of Team Clinic Care cohort participants with diabetic ketoacidosis
timeFrame: 12 months
measure: Number of Standard Care cohort participants with diabetic ketoacidosis
timeFrame: 12 months
measure: Number of Team Clinic cohort participants with severe hypoglycemia
timeFrame: 12 months
measure: Number of Standard Care cohort participants with severe hypoglycemia
timeFrame: 12 months
measure: Diabetes Family Conflict Scale
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Problem Areas in Diabetes in Caregivers
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Problem Areas in Diabetes in Teens
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Patient - Practitioner Orientation Scale
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Cost to Instituition
timeFrame: 12 months
measure: Cost to Institution - Standard care
timeFrame: 12 months
measure: Cost to Institution - Team Clinic
timeFrame: 12 months
measure: Cost to Institution - Clinic Costs
timeFrame: 12 months
measure: Cost to Institution - Team Costs
timeFrame: 12 months
measure: Cost to Institution
timeFrame: 12 months
measure: Clinical Efficiency
timeFrame: 12 months
measure: Diabetes Strengths and Resilience Measure for Children
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Diabetes Strengths and Resilience Measure for Teens
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: PROMIS - Peds Peer Relationships
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: PROMIS - Peds Family Relationships
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: PROMIS - Emotional Support
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: PROMIS - Instrumental Support
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: PROMIS - Informational Support
timeFrame: At 0 (baseline) and 12 months (after visit 4)
Other outcomes:
measure: Socio-Demographic History
timeFrame: At 0 (baseline)
measure: Medical History
timeFrame: 12 months
measure: Diabetes Treatment Regimen - glucometer
timeFrame: 12 months
measure: Diabetes Treatment Regimen - insulin pump
timeFrame: 12 months
measure: Diabetes Treatment Regimen - continuous glucose monitors
timeFrame: 12 months
measure: Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: The Child Health Utility
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Shared Medical Appointments - Patient/AYA
timeFrame: baseline to 12 months
measure: Shared Medical Appointments- Parent/caregiver
timeFrame: baseline to 12 months
measure: Self Care - Related to Diabetes as assessed by Self-Care questionnaire
timeFrame: baseline to 12 months
measure: Diabetes Family Responsbility Questionnaire - Parent
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Diabetes Family Responsbility Questionnaire - Teen
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Clinical Variables
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: ADA and CCS standards
timeFrame: 12 months
measure: Single Item Literacy Scale
timeFrame: At 0 (Baseline) and 12 months (after visit 4)
measure: Provider Centered Care Observation Form (PCOF)
timeFrame: 12 months
measure: Facilitator Centered Care Observation Form (PCOF)
timeFrame: 12 months
measure: Provider/Facilitator Session Feedback Form:
timeFrame: 12 months
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jennifer K Raymond, MD, MCR
role: PRINCIPAL_INVESTIGATOR
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