CoYoT1 to California

NCT03793673 | Completed

• 1 other identifier: CHLA-18-00488
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Adolescents and Young Adults(AYA)

Outcome Measures

Primary Outcomes (9)

• Number of participants with completed appointments in telemedicine cohort

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

  12 months

• Number of participants with completed appointments in telemedicine cohort

  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?)

  12 months

• Number of participants with completed medical appointments in standard care cohort

  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?

  12 months

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

  : 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

  12 months

• Provider Experience as assessed using the CAHPS survey

  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.

  12 months

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

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

• Provider Satisfaction as assessed using the Satisfaction Provider survey

  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.

  12 months

• Patient Experience

  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

  12 months

• Social Determinants of Health Tool

  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?"

  At 0 (baseline)

Secondary Outcomes (14)

• Costs to Patients

  12 months

• Costs to Patients

  12 months

• Costs to Patients

  12 months

• Cost to Instituition

  12 months

• Cost to Instituition

  12 months

Other Outcomes (8)

• 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)

• Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)

  At 0 (baseline) and 12 months (after visit 4)

• 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)

Study Arms (4)

Standard Care: Standard appointments

OTHER

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.

Other: Standard Care

Standard Care: Telehealth appointments

OTHER

Telehealth - with provider and/or team. See previous detailed description.

Other: Standard Care

CoYoT1 Care: Standard Appointment

OTHER

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.

Behavioral: CoYoT1 Care

CoYoT1 Care: Telehealth appointments

OTHER

Telehealth - with provider and/or team. See previous detailed description.

Behavioral: CoYoT1 Care

Interventions

CoYoT1 Care BEHAVIORAL

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.

CoYoT1 Care: Standard Appointment; CoYoT1 Care: Telehealth appointments

Standard Care OTHER

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.

Standard Care: Standard appointments; Standard Care: Telehealth appointments

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• University of Southern California: collaborator
• Rutgers University: collaborator

Study Sites (1)

Children's Hospital

Los Angeles, California, 90027, United States

Location

Related Publications (29)

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  PMID: 23340893 BACKGROUND

• Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.

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• Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7.

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• Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.

  PMID: 17881626 BACKGROUND

• Zuijdwijk CS, Cuerden M, Mahmud FH. Social determinants of health on glycemic control in pediatric type 1 diabetes. J Pediatr. 2013 Apr;162(4):730-5. doi: 10.1016/j.jpeds.2012.12.010. Epub 2013 Jan 26.

  PMID: 23360562 BACKGROUND

• Hill KE, Gleadle JM, Pulvirenti M, McNaughton DA. The social determinants of health for people with type 1 diabetes that progress to end-stage renal disease. Health Expect. 2015 Dec;18(6):2513-21. doi: 10.1111/hex.12220. Epub 2014 Jun 17.

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• Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available.

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• Introduction. Diabetes Care. 2017 Jan;40(Suppl 1):S1-S2. doi: 10.2337/dc17-S001. No abstract available.

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• Orals. Diabetes. 2013 Jul;62(Supplement_1):A1-A98. doi: 10.2337/db13-1-387. No abstract available.

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• Dinesen B, Nonnecke B, Lindeman D, Toft E, Kidholm K, Jethwani K, Young HM, Spindler H, Oestergaard CU, Southard JA, Gutierrez M, Anderson N, Albert NM, Han JJ, Nesbitt T. Personalized Telehealth in the Future: A Global Research Agenda. J Med Internet Res. 2016 Mar 1;18(3):e53. doi: 10.2196/jmir.5257.

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• Garvey KC, Beste MG, Luff D, Atakov-Castillo A, Wolpert HA, Ritholz MD. Experiences of health care transition voiced by young adults with type 1 diabetes: a qualitative study. Adolesc Health Med Ther. 2014 Oct 20;5:191-8. doi: 10.2147/AHMT.S67943. eCollection 2014.

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• Franc S, Borot S, Ronsin O, Quesada JL, Dardari D, Fagour C, Renard E, Leguerrier AM, Vigeral C, Moreau F, Winiszewski P, Vambergue A, Mosnier-Pudar H, Kessler L, Reffet S, Guerci B, Millot L, Halimi S, Thivolet C, Benhamou PY, Penfornis A, Charpentier G, Hanaire H. Telemedicine and type 1 diabetes: is technology per se sufficient to improve glycaemic control? Diabetes Metab. 2014 Feb;40(1):61-66. doi: 10.1016/j.diabet.2013.09.001. Epub 2013 Oct 16.

  PMID: 24139705 BACKGROUND

• Raymond JK. Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. Pediatr Ann. 2017 May 1;46(5):e193-e197. doi: 10.3928/19382359-20170425-01.

  PMID: 28489225 BACKGROUND

• Lehmkuhl HD, Storch EA, Cammarata C, Meyer K, Rahman O, Silverstein J, Malasanos T, Geffken G. Telehealth behavior therapy for the management of type 1 diabetes in adolescents. J Diabetes Sci Technol. 2010 Jan 1;4(1):199-208. doi: 10.1177/193229681000400125.

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• Boogerd EA, Noordam C, Kremer JA, Prins JB, Verhaak CM. Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Aug;15(5):394-402. doi: 10.1111/pedi.12103. Epub 2013 Dec 18.

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• Heyworth L, Rozenblum R, Burgess JF Jr, Baker E, Meterko M, Prescott D, Neuwirth Z, Simon SR. Influence of shared medical appointments on patient satisfaction: a retrospective 3-year study. Ann Fam Med. 2014 Jul;12(4):324-30. doi: 10.1370/afm.1660.

  PMID: 25024240 BACKGROUND

• Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.

  PMID: 27196443 BACKGROUND

• Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.

  PMID: 25717281 BACKGROUND

• Bisno DI, Reid MW, Pyatak EA, Flores Garcia J, Salcedo-Rodriguez E, Torres Sanchez A, Fox DS, Hiyari S, Fogel JL, Marshall I, Bachmann G, Raymond JK. Virtual Peer Groups Reduce HbA1c and Increase Continuous Glucose Monitor Use in Adolescents and Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2023 Sep;25(9):589-601. doi: 10.1089/dia.2023.0199. Epub 2023 Aug 17.

  PMID: 37335751 DERIVED

• Raymond JK, Reid MW, Fox S, Garcia JF, Miller D, Bisno D, Fogel JL, Krishnan S, Pyatak EA. Adapting home telehealth group appointment model (CoYoT1 clinic) for a low SES, publicly insured, minority young adult population with type 1 diabetes. Contemp Clin Trials. 2020 Jan;88:105896. doi: 10.1016/j.cct.2019.105896. Epub 2019 Nov 18.

  PMID: 31751776 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jennifer K Raymond, MD, MCR

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: January 4, 2019
• Study Start: January 20, 2019
• Primary Completion: July 28, 2022
• Study Completion: December 31, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)