CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Number of participants with completed medical appointments in standard care cohort
研究概览
简要总结
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.
详细描述
- Standard Care - Standard (in -person) appointments
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Usual medical appointments.
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Opportunity to participate in available community and CHLA based educational and support events.
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Complete online assessments/questionnaires.
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Invitation to a 2 hour audio-recorded discussion at the end of the study
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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.
- Standard Care - Telehealth appointments
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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
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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.
- CoYoT1 Care - Standard Appointment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with completed medical appointments in standard care cohort
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: [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
时间窗: 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
时间窗: 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
Number of participants with completed appointments in telemedicine cohort
时间窗: 12 months
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
次要结局
- Glycemic Control at Baseline(HbA1c for the last 12 months)
- Glycemic Control Progression(For each visit (until the end of study) - 12 months)
- Cost to Payor as as assessed using the Team Costs- YA(12 months)
- Costs to Patients(12 months)
- Cost to Instituition(12 months)
- Cost to Payor(12 months)
研究者
jennifer raymond
MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee
Children's Hospital Los Angeles