Covid 19 Clinical Trials

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.

NCT03793673 Type Type 1 Diabetes Mellitus Behavioral: CoYoT1 Care Other: Standard Care

MeSH:Diabetes Diabetes Mellitus, Type 1

HPO:Type I diabetes mellitus

Primary Outcomes

Description: Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended

Measure: Number of participants with completed appointments in telemedicine cohort

Time: 12 months

Description: 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?)

Measure: Number of participants with completed appointments in telemedicine cohort

Time: 12 months

Description: 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?

Measure: Number of participants with completed medical appointments in standard care cohort

Time: 12 months

Description: : 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

Measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire

Time: 12 months

Description: 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.

Measure: Provider Experience as assessed using the CAHPS survey

Time: 12 months

Description: 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

Measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire

Time: [Time Frame: For each visit (until the end of study) - 12 months]

Description: 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.

Measure: Provider Satisfaction as assessed using the Satisfaction Provider survey

Time: 12 months

Description: 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

Measure: Patient Experience

Time: 12 months

Description: 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?"

Measure: Social Determinants of Health Tool

Time: At 0 (baseline)

Secondary Outcomes

Description: 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.

Measure: Costs to Patients

Time: 12 months

Description: 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."

Measure: Costs to Patients

Time: 12 months

Description: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended

Measure: Costs to Patients

Time: 12 months

Description: 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?"

Measure: Cost to Instituition

Time: 12 months

Description: 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?"

Measure: Cost to Instituition

Time: 12 months

Description: 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?"

Measure: Cost to Instituition

Time: 12 months

Description: 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

Measure: Cost to Instituition

Time: 12 months

Description: 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."

Measure: Cost to Instituition

Time: 12 months

Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

Measure: Glycemic Control at Baseline

Time: HbA1c for the last 12 months

Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

Measure: Glycemic Control Progression

Time: For each visit (until the end of study) - 12 months

Description: 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?"

Measure: Cost to Payor

Time: 12 months (monthly)

Description: 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.

Measure: Cost to Payor

Time: 12 months

Description: 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."

Measure: Cost to Payor

Time: 12 months

Description: Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".

Measure: Cost to Payor as as assessed using the Team Costs- YA

Time: 12 months

Other Outcomes

Description: 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.

Measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.