Type 1 Diabetes Mellitus
Conditions
Keywords
Adolescents and Young Adults(AYA)
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.
Interventions
BEHAVIORALCoYoT1 Care
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.
OTHERStandard Care
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.
Sponsors
University of Southern California
Rutgers University
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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. |
| Number of participants with completed appointments in telemedicine cohort | 12 months | Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended |
| 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 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. |
| 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 |
| 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control Progression | For each visit (until the end of study) - 12 months | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % |
| Costs to Patients | 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. |
| Cost to Instituition | 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? |
| Glycemic Control at Baseline | HbA1c for the last 12 months | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % |
| Cost to Payor | 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? |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire. | 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. |
| Standard Care - Tools Questions | [At 12 months or Visit 4] | Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool) |
| CoYoT1 Care - Tools Questions | [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) |
| Self Care - Realted to Diabetes as assessed by Self-Care questionnaire | [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? |
| Assessment of Diabetes-Related Psychosocial Self-Efficacy | 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 |
| Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS) | 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 |
| Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure | 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. |
| Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D) | 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. |
Countries
United States
Outcome results
None listed