Type 1 Diabetes
Conditions
Keywords
Adolescents, Young Adults, Group Medical Visits
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.
Interventions
OTHERTeam Clinic Care
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
OTHERStandard Care
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.
Sponsors
University of Southern California
Cedars-Sinai Medical Center
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience | 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 |
| Number of Standard Care cohort participants completing appointments | 12 months | Electronic Medical Record (EMR) Abstraction |
| Number of Standard Clinic cohort participants completing appointments | 12 months | Attendance will be recorded for each standard care visit |
| Social Determinants of Health Tool | 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 Team Clinic Care cohort participants completing appointments | 12 months | Electronic Medical Record (EMR) Abstraction |
| Number of Virtual Team Clinic Care cohort participants completing appointments | 12 months | Attendance will be recorded for each Virtual Team Clinic Visit |
| Number of Team Clinic Care cohort participants attending appointments | 12 months | Attendance will be recorded for each Team Clinic visit |
| Hemoglobin A1C Progression | At baseline (0), 3 months, 6 months, 9 months, 12 months | HbA1c % At-Home Kit |
| Hemoglobin A1C at Baseline | baseline to 12 months | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % |
| Patient and Provider/Staff Satisfaction | 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. |
| Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost to Institution | 12 months | Cost to Institution as assessed using the Feasibility and Usability of Toolkit questionnaire. Multiple choice questions used to identify the training session, role, provider, usability of toolkit, and training time. The questionnaire also includes a 6-point Likert scale: Strongly disagree, Somewhat Disagree, Neutral, Slightly Agree, Somewhat Agree, and Strongly Agree. |
| Number of Standard Care cohort participants with diabetic ketoacidosis | 12 months | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR |
| Number of Team Clinic cohort participants with severe hypoglycemia | 12 months | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR |
| Number of Standard Care cohort participants with severe hypoglycemia | 12 months | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR |
| Diabetes Family Conflict Scale | At 0 (baseline) and 12 months (after visit 4) | Diabetes Family Conflict as assessed using the Diabetes Family Conflict Scale (DFCS) for parents and the DFCS for children. Each scale is a 20 item questionnaire using a Likert Scale (1 = Almost Never, 2 = Sometimes, 3 = Almost Always). Parent and Child questionnaires are combined with a possible score range from 40 to 120 with higher scores indicating more conflict. |
| Problem Areas in Diabetes in Caregivers | At 0 (baseline) and 12 months (after visit 4) | Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Caregivers (PAID-T). This instrument was designed to assess emotional distress related to caring for a teen with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress. |
| Problem Areas in Diabetes in Teens | At 0 (baseline) and 12 months (after visit 4) | Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Teens (PAID-T). This instrument was designed to assess emotional distress in teens with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress. |
| Cost to Instituition | 12 months | Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, have you had to be admitted to the hospital? Open-ended question about number of time health services were used, how many times were you admitted to the hospital for reasons related to diabetes? |
| Cost to Institution - Standard care | 12 months | Cost to Institution as assessed using the In Person questionnaire. Polar; Yes or No questionnaire about appointment attendance; did you attend an in-person, standard care appointment? How long was your in-person appointment? Open-ended questions about time, how long did it take? |
| Cost to Institution - Team Clinic | 12 months | Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, Team Clinic care appointment. Did you attend your in person appointment? What types of providers did you see? Open-ended questions asking about time, how long did it take? |
| Cost to Institution - Clinic Costs | 12 months | Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient. |
| Cost to Institution - Team Costs | 12 months | Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained (e.g. role), Doctor, Nurse Practitioner, Social Worker. Polar; Yes or No questions about provider and staff training for Team Clinic appointment; training on, roles of the attendees, in Team Clinic. Issues regarding the study and study toolkit. |
| Clinical Efficiency | 12 months | Assessed using the Clinical Efficiency questionnaire which captures the number of patients seen during a given time period), team members seen, and time patients spent with team members. |
| Diabetes Strengths and Resilience Measure for Children | At 0 (baseline) and 12 months (after visit 4) | DSTAR-Child assesses adaptive aspects of adolescents' diabetes management (i.e., strengths), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60. |
| Diabetes Strengths and Resilience Measure for Teens | At 0 (baseline) and 12 months (after visit 4) | DSTAR-Teen assesses adaptive aspects of adolescents' diabetes management (i.e., strengths), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60. |
| PROMIS - Peds Peer Relationships | At 0 (baseline) and 12 months (after visit 4) | Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Peer Relationships. Evaluates and monitors social health. Likert scale used to assess quality of relationships with friends and acquaintances. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always) |
| PROMIS - Peds Family Relationships | At 0 (baseline) and 12 months (after visit 4) | Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Family Relationships. Evaluates and monitors social health. Likert scale used to assess the subjective (affective, emotional, cognitive) experience of being involved with one's family, feeling like an important person in the family, of feeling accepted and cared for, and feeling that family members, especially parents, can be trusted and depended on for help and understanding. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always) |
| PROMIS - Emotional Support | At 0 (baseline) and 12 months (after visit 4) | Patient-Reported Outcomes Measurement Information System (PROMIS )- Emotional Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing perceived feelings of being cared for and valued as a person; having confidant relationships. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always) |
| PROMIS - Instrumental Support | At 0 (baseline) and 12 months (after visit 4) | Patient-Reported Outcomes Measurement Information System (PROMIS )- Instrumental Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of assistance with material, cognitive or task performance. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always) |
| PROMIS - Informational Support | At 0 (baseline) and 12 months (after visit 4) | Patient-Reported Outcomes Measurement Information System (PROMIS )- Informational Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of helpful information or advice.. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always) |
| Patient - Practitioner Orientation Scale | At 0 (baseline) and 12 months (after visit 4) | Patient - Practitioner Orientation Scale consists of 18 items and 2 subscales. It assesses provider beliefs on patient centeredness. 6-point Likert scale: Strongly disagree, Moderately Disagree, Slightly Disagree, Slightly Agree, Moderately Agree, and Strongly Agree. PPOs score is computed by taking the mean of the 18 items with a minimum score being 1 and maximum being 6. Higher scores present more patient-centered attitudes. |
| Number of Team Clinic Care cohort participants with diabetic ketoacidosis | 12 months | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Family Responsbility Questionnaire - Teen | At 0 (baseline) and 12 months (after visit 4) | Asseses how parents/caregivers of children/teens living with T1D share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. Child is 1, equal is 2, and parent is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management. |
| Clinical Variables | At 0 (baseline) and 12 months (after visit 4) | Polar; Yes or No questionnaire. Data extracted from EMR : cholesterol, high density lipoprotein, triglycerides, smoking status, nephropathy, microalbuminaria, macroalbuminaria, end-stage renal disease (death from end-stage renal disease), neuropathy, peripheral arterial disease (low extremity amputation), retinopathy (proliferative retinopathy), macular edema, blindness, angina, myocardial infarction, stroke, heart failure, revascularization (Coronary artery bypass grafting, PCA, and stenting). If answered yes for the following: ergosterol, HDL,microalbuminaria, and macroalbuminaria, values will be recorded. |
| ADA and CCS standards | 12 months | EMR abstraction: Questions assess compliance with ADA and CCS standards when patients have contact with all team members annually. This will be noted with polar questions Yes or No. This will be tracked for all patients in the study (e.g., Team Clinic and Standard Clinic). |
| Single Item Literacy Scale | At 0 (Baseline) and 12 months (after visit 4) | Literacy assessed using the Single Item Literacy Scale. Multiple choice question asking about suppoort needed with reading materials. Options, never, rarely, sometimes, often, always |
| Provider Centered Care Observation Form (PCOF) | 12 months | Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, Establishes Rapport, Maintain Relationship Throughout the Visit, Collaborative upfront agenda setting, Maintain Efficiency using transparent thinking and respectful interruption, Gathering information, Assessing patient or family perspective on health, Electronic Medical Record Use, Physical Exam |
| Facilitator Centered Care Observation Form (PCOF) | 12 months | Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, Establishes Rapport, Maintains Relationship Trhoughout the Visit, Session Introduction and Icebreaker, Session Preparation, Gathering Information, Assessing Patient or Family Persepctive on Health/Understanding Context, Blood Glucose Charting, Blood Glucose Discussion, Activity Kit Review |
| Provider/Facilitator Session Feedback Form: | 12 months | Assess provider experience during clinic visit and patient-center delivery. Multiple choice, Establishing Rapport and Maintaining Relationship, Agenda-setting, Thinking Out-Loud, and Collaboration, Gathering Information and Understanding Context, EMR Review and Physical Exam, Promoting Behavior Change or Self-Management, Collaborative Planning and Closure, None of these |
| Shared Medical Appointments- Parent/caregiver | baseline to 12 months | Likert scale;Strongly disagree is 1, disagree is 2, neutral is 3, agree is 4, strongly agree is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments. |
| Socio-Demographic History | At 0 (baseline) | Self-reported demographic history (gender, age, race, household income, etc) will be collected. |
| Shared Medical Appointments - Patient/AYA | baseline to 12 months | Likert scale; Strongly disagree is 1, disagree is 2, neutral is 3, agree is 4, strongly agree is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments. |
| Patient Health Questionnaire-8 (PHQ-8) | At 0 (baseline) and 12 months (after visit 4) | Composed of 8 items to screen, diagnose, and measure the severity of depression. |
| The Child Health Utility | At 0 (baseline) and 12 months (after visit 4) | The Child Health Utility 9 dimensions assesses health-related quality of life (HRQoL). Multiple choice used to capture respondents' endorsement of particular statements about experience. I don't feel \[upset\] today, I feel a little bit \[upset\] today, I feel a bit \[upset\] today, I feel quite \[upset\] today, I feel very \[upset\] today |
| Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire | At 0 (baseline) and 12 months (after visit 4) | Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score. |
| Diabetes Treatment Regimen - continuous glucose monitors | 12 months | Diabetes treatment regimen assessed through percentage of glucose values low, in target, or high for patients on continuous glucose monitors will be collected from devices and EMR. |
| Diabetes Treatment Regimen - insulin pump | 12 months | Diabetes treatment regimen assessed through insulin boluses per day from insulin pump downloads will be collected from devices and EMR. |
| Diabetes Treatment Regimen - glucometer | 12 months | Diabetes treatment regimen assessed through blood glucose checks per day from glucometer downloads will be collected from devices and EMR. |
| Medical History | 12 months | General health history via self report and EMR |
| Diabetes Family Responsbility Questionnaire - Parent | At 0 (baseline) and 12 months (after visit 4) | Asseses how adolescents with T1D and their families/caregivers share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. Child is 1, equal is 2, and parent is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management. |
| Self Care - Related to Diabetes as assessed by Self-Care questionnaire | baseline to 12 months | Multiple Choice. Questions about diabetes related self care, How many hours per day do you currently devote to managing your glucose levels? |
Countries
United States
Outcome results
None listed