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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Team Clinic Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusions 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Team Clinic Care: No VTC Groups<br>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<br>* 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<br>|
| Other: Team Clinic: Virtual Team Clinic Group<br>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<br>* 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<br>|
| Other: Standard Care: No VTC Groups<br>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<br>* 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.<br>|
| Other: Standard Care: Virtual Team Clinic<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problem Areas in Diabetes in Teens | 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. | At 0 (baseline) and 12 months (after visit 4) | 
| Patient - Practitioner Orientation Scale | 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. | At 0 (baseline) and 12 months (after visit 4) | 
| Cost to Instituition | 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? | 12 months | 
| Cost to Institution - Standard care | 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? | 12 months | 
| Cost to Institution - Team Clinic | 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? | 12 months | 
| Cost to Institution - Clinic Costs | 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. | 12 months | 
| Cost to Institution - Team Costs | 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. | 12 months | 
| Cost to Institution | 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. | 12 months | 
| Clinical Efficiency | 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. | 12 months | 
| Diabetes Strengths and Resilience Measure for Children | 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. | At 0 (baseline) and 12 months (after visit 4) | 
| Diabetes Strengths and Resilience Measure for Teens | 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. | At 0 (baseline) and 12 months (after visit 4) | 
| PROMIS - Peds Peer Relationships | 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) | At 0 (baseline) and 12 months (after visit 4) | 
| PROMIS - Peds Family Relationships | 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) | At 0 (baseline) and 12 months (after visit 4) | 
| PROMIS - Emotional Support | 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) | At 0 (baseline) and 12 months (after visit 4) | 
| PROMIS - Instrumental Support | 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) | At 0 (baseline) and 12 months (after visit 4) | 
| PROMIS - Informational Support | 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) | At 0 (baseline) and 12 months (after visit 4) | 
| Number of Team Clinic Care cohort participants with diabetic ketoacidosis | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR | 12 months | 
| Number of Standard Care cohort participants with diabetic ketoacidosis | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR | 12 months | 
| Number of Team Clinic cohort participants with severe hypoglycemia | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR | 12 months | 
| Number of Standard Care cohort participants with severe hypoglycemia | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR | 12 months | 
| Diabetes Family Conflict Scale | 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. | At 0 (baseline) and 12 months (after visit 4) | 
| Problem Areas in Diabetes in Caregivers | 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. | At 0 (baseline) and 12 months (after visit 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Young Adults, Group Medical Visits