Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes

NCT04190368 | Completed

• 1 other identifier: CHLA-19-00062
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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. 1.Standard Care - No Group
2. 2.Standard Care - Virtual Team Clinic Group
3. 3.Team Clinic Care - No Group
4. 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.)
5. 5.Patients and parents will attend their own online session

Conditions

Type 1 Diabetes

Keywords

Adolescents; Young Adults; Group Medical Visits

Outcome Measures

Primary Outcomes (11)

• Hemoglobin A1C at Baseline

  Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

  baseline to 12 months

• Hemoglobin A1C Progression

  HbA1c % At-Home Kit

  At baseline (0), 3 months, 6 months, 9 months, 12 months

• Number of Team Clinic Care cohort participants attending appointments

  Attendance will be recorded for each Team Clinic visit

  12 months

• Number of Virtual Team Clinic Care cohort participants completing appointments

  Attendance will be recorded for each Virtual Team Clinic Visit

  12 months

• Number of Team Clinic Care cohort participants completing appointments

  Electronic Medical Record (EMR) Abstraction

  12 months

• Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire

  Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction

  12 months

• Patient and Provider/Staff Satisfaction

  Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.

  12 months

• Patient Experience

  Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating

  12 months

• Social Determinants of Health Tool

  Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"

  At 0 (baseline)

• Number of Standard Clinic cohort participants completing appointments

  Attendance will be recorded for each standard care visit

  12 months

• Number of Standard Care cohort participants completing appointments

  Electronic Medical Record (EMR) Abstraction

  12 months

Secondary Outcomes (22)

• Number of Team Clinic Care cohort participants with diabetic ketoacidosis

  12 months

• Number of Standard Care cohort participants with diabetic ketoacidosis

  12 months

• Number of Team Clinic cohort participants with severe hypoglycemia

  12 months

• Number of Standard Care cohort participants with severe hypoglycemia

  12 months

• Diabetes Family Conflict Scale

  At 0 (baseline) and 12 months (after visit 4)

Other Outcomes (19)

• Socio-Demographic History

  At 0 (baseline)

• Medical History

  12 months

• Diabetes Treatment Regimen - glucometer

  12 months

Study Arms (4)

Team Clinic Care: No VTC Groups

OTHER

Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments

Other: Team Clinic Care

Team Clinic: Virtual Team Clinic Group

OTHER

Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) 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. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Other: Team Clinic Care

Standard Care: No VTC Groups

OTHER

Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services).

Other: Standard Care

Standard Care: Virtual Team Clinic

OTHER

Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Other: Standard Care

Interventions

Team Clinic Care OTHER

Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient. Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components: (1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment

Team Clinic Care: No VTC Groups; Team Clinic: Virtual Team Clinic Group

Standard Care OTHER

Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.

Standard Care: No VTC Groups; Standard Care: Virtual Team Clinic

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of type 1 diabetes \> 6 month duration
• Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
• Not currently participating in other group interventions
• English speaking
• Severe behavioral or developmental disabilities in parent or child
• Severe psychological diagnoses in parent or child that would make group participation difficult
• Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
• Non-English speaking

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• University of Southern California: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jennifer K Raymond, MD, MCR

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: December 9, 2019
• Study Start: September 7, 2021
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.

Locations

US (1)