CoYoT1 to California
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Other: Standard CareBehavioral: CoYoT1 Care
- Registration Number
- NCT03793673
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Standard Care: Standard appointments Standard Care 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. CoYoT1 Care: Telehealth appointments CoYoT1 Care Telehealth - with provider and/or team. See previous detailed description. Standard Care: Telehealth appointments Standard Care Telehealth - with provider and/or team. See previous detailed description. CoYoT1 Care: Standard Appointment CoYoT1 Care 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.
- Primary Outcome Measures
Name Time Method Number of participants with completed appointments in telemedicine cohort 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?)
Number of participants with completed medical appointments in standard care cohort 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?
Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire 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
Provider Experience as assessed using the CAHPS survey 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.
Social Determinants of Health Tool 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?"
Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire [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
Provider Satisfaction as assessed using the Satisfaction Provider survey 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.
Patient Experience 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
- Secondary Outcome Measures
Name Time Method Glycemic Control at Baseline HbA1c for the last 12 months Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Costs to Patients 12 months Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Cost to Instituition 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."
Glycemic Control Progression For each visit (until the end of study) - 12 months Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Cost to Payor 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."
Cost to Payor as as assessed using the Team Costs- YA 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".
Trial Locations
- Locations (1)
Children's Hospital
🇺🇸Los Angeles, California, United States