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CoYoT1 to California (CTC)

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ClinicalTrials.gov Identifier: NCT03793673
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
jennifer raymond, Children's Hospital Los Angeles

Tracking Information
First Submitted Date  ICMJE November 23, 2018
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE January 20, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Number of participants with completed appointments in telemedicine cohort [ Time Frame: 12 months ]
    Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
  • Number of participants with completed appointments in telemedicine cohort [ 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?)
  • Number of participants with completed medical appointments in standard care cohort [ 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?
  • Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire [ 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
  • Patient and Provider 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.
  • Provider Satisfaction [ 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.
  • Patient 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
  • Social Determinants of Health Tool [ 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?"
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • Number of participants with completed appointments in telemedicine cohort [ Time Frame: 12 months ]
    Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
  • Number of participants with completed appointments in telemedicine cohort [ 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?)
  • Number of participants with completed medical appointments in standard care cohort [ 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?
  • Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire [ 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
  • Patient and Provider 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.
  • Patient and Provider Satisfaction [ 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.
  • Patient 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
Change History Complete list of historical versions of study NCT03793673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • Costs to Patients [ 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.
  • Costs to Patients [ 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."
  • Costs to Patients [ Time Frame: 12 months ]
    Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
  • Cost to Instituition [ 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?"
  • Cost to Instituition [ 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?"
  • Cost to Instituition [ 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?"
  • Cost to Instituition [ 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
  • Cost to Instituition [ 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."
  • Glycemic Control at Baseline [ Time Frame: HbA1c for the last 12 months ]
    Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
  • Glycemic Control Progression [ Time Frame: For each visit (until the end of study) - 12 months ]
    Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
  • Cost to Payor [ 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?"
  • Cost to Payor [ 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.
  • Cost to Payor [ 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."
  • Cost to Payor assessed using the Team Costs - Provider & Staff questionnaire [ Time Frame: 12 months ]
    Multiple Choice (e.g., roles of trainer - MD, RD, RN, and etc.)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2019)
  • Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire. [ 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.
  • Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D) [ 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.
  • Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure [ 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.
  • Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS) [ 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
  • Assessment of Diabetes-Related Psychosocial Self-Efficacy [ 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CoYoT1 to California
Official Title  ICMJE CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
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.
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
  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
  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
  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Behavioral: CoYoT1 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.
  • Other: Standard 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.
Study Arms  ICMJE
  • Standard Care: Standard appointments
    Usual in-person medical appointments. See previous detailed description.
    Intervention: Other: Standard Care
  • Standard Care: Telehealth appointments
    Telehealth - with provider and/or team. See previous detailed description.
    Intervention: Other: Standard Care
  • CoYoT1 Care: Standard Appointment
    In-person - medical appointments with provider and/or team. See previous detailed description.
    Intervention: Behavioral: CoYoT1 Care
  • CoYoT1 Care: Telehealth appointments
    Telehealth - with provider and/or team. See previous detailed description.
    Intervention: Behavioral: CoYoT1 Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaquelin J Flores Garcia, BS 323-361-4842 ext 14842 jfloresgarcia@chla.usc.edu
Contact: Alejandra Torres Sanchez, BA 323-361-3312 ext 13312 atorressanchez@chla.usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793673
Other Study ID Numbers  ICMJE CHLA-18-00488
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party jennifer raymond, Children's Hospital Los Angeles
Study Sponsor  ICMJE Children's Hospital Los Angeles
Collaborators  ICMJE University of Southern California
Investigators  ICMJE
Principal Investigator: Jennifer K Raymond, MD, MCR Children's Hospital Los Angeles
PRS Account Children's Hospital Los Angeles
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP