CoYoT1 to California

Study Overview
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Brief Summary
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CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that consists of three major components: shared decision making (patient and provider agree upon priorities for the medical visit), autonomy and supportive care (provider training in communication strategies such as motivational interviewing), and goal setting and action planning (provider training to coach YA in setting SMART goals, developing action plans, and designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a focus group will be completed to assist in determining which features YA felt were critical to their success from the telehealth intervention, group components, and provider behaviors. ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all participants who were randomized into in-person appointments will now receive care via Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery of care method during this pandemic. Participants have been notified of this change and given instruction on how to participate in a Telehealth appointment.

Detailed Description
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Standard Care - Standard (in -person) appointments Usual medical appointments. Opportunity to participate in available community and CHLA based educational and support events. Complete online assessments/questionnaires. Invitation to a 2 hour audio-recorded discussion at the end of the study COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines. Standard Care - Telehealth appointments Telehealth - with provider and/or team. Online video appointments every 3 months, upload diabetes data to Tidepool, and do routine blood work at a facility near you Opportunity to participate in available community and CHLA based educational and support events Complete online assessments/questionnaires Invitation to a 2 hour audio-recorded discussion at the end of the study COVID-19 Update: Any community and CHLA based educational and support events will be following COVID-19 guidelines. If in-person routine bloodwork is not feasible, HbA1c kits will be provided to participants. CoYoT1 Care - Standard Appointment In-person - medical appointments with provider and/or team Opportunity to participate in 30-60 minute online peer-led diabetes group discussions Complete online assessments/questionnaires Invitation to a 2 hour audio-recorded discussion at the end of the study COVID-19 Update: Current clinic appointments consist of telehealth appointments only. CoYoT1 Care - Telehealth appointments Telehealth - with provider and/or team. Online video appointment every 3 months, upload your diabetes data to Tidepool, and do routine blood work at a facility near you Opportunity to participate in 30-60 minute online peer-led diabetes group discussions Complete online assessments/questionnaires Invitation to a 2 hour audio-recorded discussion at the end of the study COVID-19 Update: If in-person routine bloodwork is not feasible, HbA1c kits will be provided to participants.

Official Title
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CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: CoYoT1 Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient aged 16-25 years of age on their date of recruitment who has had T1D for at least 6 months. Receiving or pending care at CHLA Has California Children's Services (CCS), self-pay, and/or private insurance (excluding United and Healthnet insurance) Does not plan to transfer out of CHLA within the next year Exclusion Criteria: Any patient with severe behavioral or developmental disabilities Severe psychological diagnoses that would make group participation difficult Pregnancy Non-English speaking patients and families Has United or Healthnet private insurance Literacy or cognitive issues that preclude the use of the Internet

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care: Standard appointments<br>Usual in-person medical appointments. See previous detailed description. COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines. | Other: Standard Care<br>* Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care. NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.<br>|
| Other: Standard Care: Telehealth appointments<br>Telehealth - with provider and/or team. See previous detailed description. | Other: Standard Care<br>* Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care. NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.<br>|
| Other: CoYoT1 Care: Standard Appointment<br>In-person - medical appointments with provider and/or team. See previous detailed description. COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines. | Behavioral: CoYoT1 Care<br>* Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.<br>|
| Other: CoYoT1 Care: Telehealth appointments<br>Telehealth - with provider and/or team. See previous detailed description. | Behavioral: CoYoT1 Care<br>* Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with completed appointments in telemedicine cohort | Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended | 12 months | 
| Number of participants with completed appointments in telemedicine cohort | Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?) | 12 months | 
| Number of participants with completed medical appointments in standard care cohort | In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment? | 12 months | 
| Patient and Provider 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 | 
| Provider Experience as assessed using the CAHPS survey | 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 Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire | Likert scale; Strongly disagree is 1, Somewhat disagree is 2, Neutral is 3, Somewhat Agree is 4, and Strongly Agree is 5. Scores are summed and the average is taken; higher scores is more self-efficacy | [Time Frame: For each visit (until the end of study) - 12 months] | 
| Provider Satisfaction as assessed using the Satisfaction Provider survey | Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, Would you use telehealth again? Open ended; patient comments about experience. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs to Patients | Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, driving own vehicle, riding public transit, ride with family member or friend. Open ended to assess cost of parking, bus fare. | 12 months | 
| Costs to Patients | Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, do you have a personal device to access the internet?. Multiple choice questions about device; Mobile phone, Laptop, Tablet, Ethernet, Wi-Fi. | 12 months | 
| Costs to Patients | Diabetes visit expenses questions - polar questions, multiple choice, and open-ended | 12 months | 
| 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 Instituition | Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. Did you attend your online appointment? What types of providers did you see? Open-ended questions asking about time, how long did it take? | 12 months | 
| Cost to Instituition | Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; did you attend an in-person appointment? How long was your in-person appointment? Open-ended questions about time, how long did it take? | 12 months | 
| Cost to Instituition | 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 Instituition | Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, Doctor, Nurse Practitioner, Social Worker. Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, camera and mic, loading Webex platform. | 12 months | 
| Glycemic Control at Baseline | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % | HbA1c for the last 12 months | 
| Glycemic Control Progression | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % | For each visit (until the end of study) - 12 months | 
| Cost to Payor | Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, In the last 3 months, has 911 been called because of your diabetes? Open-ended questions about rate of health service use, how many times was 911 called? | 12 months (monthly) | 
| Cost to Payor | Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery. | 12 months | 
| Cost to Payor | Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on billing process, data collection process, camera and mic. | 12 months | 
| Cost to Payor as as assessed using the Team Costs- YA | Multiple Choice and fill-in. Questions about time spent training young adults and training required on Agenda setting, Camera and Mic, Loading Webex platform. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents and Young Adults(AYA)