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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C at Baseline
研究概览
简要总结
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:
- Standard Care - No Group
- Standard Care - Virtual Team Clinic Group
- Team Clinic Care - No Group
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hemoglobin A1C at Baseline
时间窗: baseline to 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Hemoglobin A1C Progression
时间窗: At baseline (0), 3 months, 6 months, 9 months, 12 months
HbA1c % At-Home Kit
Number of Team Clinic Care cohort participants attending appointments
时间窗: 12 months
Attendance will be recorded for each Team Clinic visit
Number of Virtual Team Clinic Care cohort participants completing appointments
时间窗: 12 months
Attendance will be recorded for each Virtual Team Clinic Visit
Number of Team Clinic Care cohort participants completing appointments
时间窗: 12 months
Electronic Medical Record (EMR) Abstraction
Patient Experience
时间窗: 12 months
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
Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire
时间窗: 12 months
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
Patient and Provider/Staff Satisfaction
时间窗: 12 months
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.
Social Determinants of Health Tool
时间窗: At 0 (baseline)
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?"
Number of Standard Care cohort participants completing appointments
时间窗: 12 months
Electronic Medical Record (EMR) Abstraction
Number of Standard Clinic cohort participants completing appointments
时间窗: 12 months
Attendance will be recorded for each standard care visit
次要结局
- 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 Standard Care cohort participants with severe hypoglycemia(12 months)
- Number of Team Clinic cohort participants with severe hypoglycemia(12 months)
- Diabetes Family Conflict Scale(At 0 (baseline) and 12 months (after visit 4))
- Cost to Instituition(12 months)
- Problem Areas in Diabetes in Caregivers(At 0 (baseline) and 12 months (after visit 4))
- Problem Areas in Diabetes in Teens(At 0 (baseline) and 12 months (after visit 4))
- Patient - Practitioner Orientation Scale(At 0 (baseline) and 12 months (after visit 4))
- Cost to Institution(12 months)
- Clinical Efficiency(12 months)
- PROMIS - Peds Family Relationships(At 0 (baseline) and 12 months (after visit 4))
- Cost to Institution - Standard care(12 months)
- Cost to Institution - Team Clinic(12 months)
- Cost to Institution - Clinic Costs(12 months)
- Cost to Institution - Team Costs(12 months)
- Diabetes Strengths and Resilience Measure for Children(At 0 (baseline) and 12 months (after visit 4))
- Diabetes Strengths and Resilience Measure for Teens(At 0 (baseline) and 12 months (after visit 4))
- PROMIS - Emotional Support(At 0 (baseline) and 12 months (after visit 4))
- PROMIS - Instrumental Support(At 0 (baseline) and 12 months (after visit 4))
- PROMIS - Informational Support(At 0 (baseline) and 12 months (after visit 4))
- PROMIS - Peds Peer Relationships(At 0 (baseline) and 12 months (after visit 4))
研究者
jennifer raymond
MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee
Children's Hospital Los Angeles