Type 2 Diabetes
Conditions
Brief summary
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: * Is shared medical appointments an acceptable care delivery model for this population? * Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.
Interventions
OTHERStandard of Care
Multidisciplinary team based care every 3 months.
BEHAVIORALShared Medical Appointments
Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.
Sponsors
University of California, San Francisco
American Diabetes Association
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Patient/AYA Participants Inclusion Criteria: * Receives care for type 2 diabetes at either CHLA or UCSF * English speaking youth * Youth prescribed medication for type 2 diabetes * English or Spanish speaking caregivers * Age 12 to 18 years old at the time of enrollment * Willingness to attend clinic visits and participate in group session (if randomized to Team Clinic), complete surveys
Exclusion criteria
* Participants who are non-verbal or unable to participate in group activities and discussions * Pregnancy * Inability or unwillingness of individual or legal guardian/representative to give written informed assent/consent Caregiver/Parents Participants Inclusion Criteria: * Has a child between the ages of 12 and up to 18 at the time of enrollment who receives care for T2D in the endocrinology clinic at CHLA. The child must provide consent/assent to participate as a youth participant. * Speaks English of Spanish. Over 95% of our T2D population speaks one of those two languages. Our facilitator will be bilingual in English and Spanish. It is not feasible for the facilitator to also speak another language. Having a language interpreter for discussion groups will affect the dynamics and flow of the group session * Willingness to participate in group session (if their child is randomized to Team Clinic) and complete surveys.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of clinics attended over 1 year period to be recorded by Study Coordinator | 1 year | Data collected is the number of patient visits to the clinic. |
| Change in HbA1c for patients from baseline to end of study | 1 year | Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period |
| Clinic Satisfaction | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dietary intake for patients before and after delivery of the dietary intervention | three months | The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits before and after delivery of the intervention (session 2). |
| Depression score | 1 year | 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. |
| Quality of life for patients | 1 year | The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management. |
| Beliefs about Medicines for patients and parent/caregiver over one year | 1 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. |
| Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year | 1 year | A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control |
| Diabetes distress for patients over 1 year period | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication Review | baseline to one year | General health history through review of participants EMR, completed by study coordinator |
| Patient experience for patient and parent/caregiver | 1 year | 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. |
| Discontinuation and Termination Form | baseline to one year | The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator. |
| Adverse Events Form | baseline to one year | 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 |
| Demographic for Patients and Parents/Caregivers | baseline | Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected. |
| Sociodemographic History for Parents/Caregivers | baseline | Self-reported sociodemographic history (work status, marital members, household income, etc) |
| Implementation Outcome Measures for Research Staff | At end of study (end of 1 year) | 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. |
| Parent/Caregiver Clinic Satisfaction Survey | 1 year | 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. |
| Shared Decision Making for Team Clinic Patients and Parents/Caregivers over one year | 1 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. |
| Research Team Appointment Satisfaction Survey | 1 year | 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. |
| Clinician Goals/Plans for Clinicians | 1 year | 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. |
| Healthcare Utilization Form | 1 year | Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon. |
Countries
United States
Contacts
Primary ContactFatima Aguilar
Backup ContactLily Chao, MD
Outcome results
None listed