Children's Hospital
Los Angeles, California, 90027, United States
NCT Number: NCT03793673
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.
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Notify Me16 year–25 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Time frame: 12 months
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
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
: 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
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: [Time Frame: For each visit (until the end of study) - 12 months]
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: 12 months
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 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: 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?"
Time frame: 12 months
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
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
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Time frame: 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?"
Time frame: 12 months
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 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?"
Time frame: 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
Time frame: 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, "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: HbA1c for the last 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time frame: For each visit (until the end of study) - 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time frame: 12 months (monthly)
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
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 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
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: 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.
Time frame: At 0 (baseline) and 12 months (after visit 4)
"Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Time frame: At 0 (baseline) and 12 months (after visit 4)
Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
Time frame: At 0 (baseline) and 12 months (after visit 4)
Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress.
burden, regimen distress, interpersonal distress and physician distress; likert scale
Time frame: At 0 (baseline) and 12 months (after visit 4)
Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); 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: [At 0 (baseline) and each visit (until the end of study) - 12 months]
Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
Time frame: [At 12 months or Visit 4]
Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)
Time frame: [At 12 months or Visit 4]
Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)
Children's Hospital Los Angeles
Other
CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
Acronym: CTC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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