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.
1. 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. 2. 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. 3. 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. 4. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
82
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.
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.
Children's Hospital
Los Angeles, California, United States
Number of participants with completed appointments in telemedicine cohort
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Time frame: 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?)
Time frame: 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?
Time frame: 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
Time frame: 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.
Time frame: 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: [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.
Time frame: 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
Time frame: 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?"
Time frame: At 0 (baseline)
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.
Time frame: 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."
Time frame: 12 months
Costs to Patients
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Time frame: 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?"
Time frame: 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?"
Time frame: 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?"
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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."
Time frame: 12 months
Glycemic Control at Baseline
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time frame: HbA1c for the last 12 months
Glycemic Control Progression
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time frame: 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?"
Time frame: 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.
Time frame: 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."
Time frame: 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".
Time frame: 12 months