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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| American Diabetes Association | OTHER |
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The goal of this clinical trial is to learn if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes.
The main question[s] it aims to answer are:
Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Placebo Comparator | Multidisciplinary team based care every 3 months. |
|
| Shared Medical Appointment | Active Comparator | Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Multidisciplinary team based care every 3 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of clinics attended over 1 year period to be recorded by Study Coordinator | Data collected is the number of patient visits to the clinic. | 1 year |
| Change in HbA1c for patients from baseline to end of study | Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period | 1 year |
| Clinic Satisfaction | Patient participants will complete satisfaction survey at the end of each visit using a 5-point Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Depression score | The patient health questionnaire-8 is a measure of depression severity that will be administered at baseline and again at the end of the study. | 1 year |
| Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience for patient and parent/caregiver | The Consumer Assessment of Healthcare Providers & Systems survey (CAHPS)assesses patient-clinician communication, experiences of discrimination based on race/ethnicity, insurance, and experiences leading to trust or distrust. Patient experience will be compared between control and intervention groups, both at baseline and at one year. | 1 year |
Patient/AYA Participants
Inclusion Criteria:
Exclusion Criteria:
Caregiver/Parents Participants
Inclusion Criteria:
Exclusion Criteria:
-Inability or unwillingness of individual to give written informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatima Aguilar | Contact | 323-361-4606 | faguilar@chla.usc.edu | |
| Lily Chao, MD | Contact | 323-361-4606 | chao@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lily Chao, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 91316 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000079142 | Shared Medical Appointments |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Shared Medical Appointments |
| Behavioral |
Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics. |
|
A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control |
| 1 year |
| Diabetes distress for patients over 1 year period | The Diabetes Distress Scale 2 is a 2 question prescreen that will be used to prescreen emotional burden. A score of 3 or higher on the DDS-2 will lead to the use of the 17-item survey. | 1 year |
| Change in dietary intake for patients before and after delivery of the dietary intervention | The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits before and after delivery of the intervention (session 2). | three months |
| Beliefs about Medicines for patients and parent/caregiver over one year | Beliefs about Medicines Questionnaire (BMQ) is used to any change in patients beliefs and concerns about medications. It has been validated as a proxy for medication adherence. | 1 year |
| Quality of life for patients | The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management. | 1 year |
| Demographic for Patients and Parents/Caregivers | Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected. | baseline |
| Sociodemographic History for Parents/Caregivers | Self-reported sociodemographic history (work status, marital members, household income, etc) | baseline |
| Implementation Outcome Measures for Research Staff | Implementation Outcome measure is used in behavioral health care as a psycho metric quality and will be used to assess how effectively clinic is being implemented. | At end of study (end of 1 year) |
| Parent/Caregiver Clinic Satisfaction Survey | Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. | 1 year |
| Shared Decision Making for Team Clinic Patients and Parents/Caregivers over one year | Shared decision making tool assess AYA and parent/caregiver's priorities for each medical visit using a mix of multiple choice and open-ended questions. | 1 year |
| Research Team Appointment Satisfaction Survey | Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 4 open-ended questions to measures satisfaction for shared medical appointments. | 1 year |
| Clinician Goals/Plans for Clinicians | Clinicians will work with families to discuss goals and plans guided by responding to 5 open-ended questions at each visit. Each member (Clinician, family, and AYA) will respond to these questions. | 1 year |
| Healthcare Utilization Form | Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon. | 1 year |
| Medication Review | General health history through review of participants EMR, completed by study coordinator | baseline to one year |
| Adverse Events Form | The adverse events form will track any ED visits related to diabetes, DKA admissions, etc. throughout the study. It will be completed by Study Coordinator | baseline to one year |
| Discontinuation and Termination Form | The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator. | baseline to one year |
| University of California, San Francisco | Not yet recruiting | San Francisco | California | 94143-0434 | United States |
| D004700 | Endocrine System Diseases |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D011216 | Practice Management, Medical |
| D020399 | Practice Management |
| D011364 | Professional Practice |