Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Standard CareOther: Team Clinic Care
- Registration Number
- NCT04190368
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief Summary
Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.
Groups:
1. Standard Care - No Group
2. Standard Care - Virtual Team Clinic Group
3. Team Clinic Care - No Group
4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)
* Patients and parents will attend their own online session
- Detailed Description
Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Standard Care: Virtual Team Clinic Standard Care Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed Team Clinic Care: No VTC Groups Team Clinic Care Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments Standard Care: No VTC Groups Standard Care Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). Team Clinic: Virtual Team Clinic Group Team Clinic Care Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed
- Primary Outcome Measures
Name Time Method Hemoglobin A1C at Baseline baseline to 12 months Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Hemoglobin A1C Progression At baseline (0), 3 months, 6 months, 9 months, 12 months HbA1c % At-Home Kit
Number of Team Clinic Care cohort participants attending appointments 12 months Attendance will be recorded for each Team Clinic visit
Number of Virtual Team Clinic Care cohort participants completing appointments 12 months Attendance will be recorded for each Virtual Team Clinic Visit
Number of Team Clinic Care cohort participants completing appointments 12 months Electronic Medical Record (EMR) Abstraction
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
Patient and Provider/Clinic Staff 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
Patient and Provider/Staff Satisfaction 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?"
Number of Standard Care cohort participants completing appointments 12 months Electronic Medical Record (EMR) Abstraction
Number of Standard Clinic cohort participants completing appointments 12 months Attendance will be recorded for each standard care visit
- Secondary Outcome Measures
Name Time Method Number of Team Clinic Care cohort participants with diabetic ketoacidosis 12 months Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR
Number of Standard Care cohort participants with diabetic ketoacidosis 12 months Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR
Number of Standard Care cohort participants with severe hypoglycemia 12 months Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR
Number of Team Clinic cohort participants with severe hypoglycemia 12 months Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR
Diabetes Family Conflict Scale At 0 (baseline) and 12 months (after visit 4) Diabetes Family Conflict as assessed using the Diabetes Family Conflict Scale (DFCS) for parents and the DFCS for children. Each scale is a 20 item questionnaire using a Likert Scale (1 = Almost Never, 2 = Sometimes, 3 = Almost Always). Parent and Child questionnaires are combined with a possible score range from 40 to 120 with higher scores indicating more conflict.
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?"
Problem Areas in Diabetes in Caregivers At 0 (baseline) and 12 months (after visit 4) Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Caregivers (PAID-T). This instrument was designed to assess emotional distress related to caring for a teen with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.
Problem Areas in Diabetes in Teens At 0 (baseline) and 12 months (after visit 4) Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Teens (PAID-T). This instrument was designed to assess emotional distress in teens with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.
Patient - Practitioner Orientation Scale At 0 (baseline) and 12 months (after visit 4) Patient - Practitioner Orientation Scale consists of 18 items and 2 subscales. It assesses provider beliefs on patient centeredness. 6-point Likert scale: "Strongly disagree," "Moderately Disagree," "Slightly Disagree," "Slightly Agree," "Moderately Agree," and "Strongly Agree." PPOs score is computed by taking the mean of the 18 items with a minimum score being "1" and maximum being "6." Higher scores present more patient-centered attitudes.
Cost to Institution 12 months Cost to Institution as assessed using the Feasibility and Usability of Toolkit questionnaire. Multiple choice questions used to identify the training session, role, provider, usability of toolkit, and training time. The questionnaire also includes a 6-point Likert scale: "Strongly disagree," "Somewhat Disagree," "Neutral," "Slightly Agree," "Somewhat Agree," and "Strongly Agree."
Clinical Efficiency 12 months Assessed using the Clinical Efficiency questionnaire which captures the number of patients seen during a given time period), team members seen, and time patients spent with team members.
PROMIS - Peds Family Relationships At 0 (baseline) and 12 months (after visit 4) Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Family Relationships. Evaluates and monitors social health. Likert scale used to assess the subjective (affective, emotional, cognitive) experience of being involved with one's family, feeling like an important person in the family, of feeling accepted and cared for, and feeling that family members, especially parents, can be trusted and depended on for help and understanding. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Cost to Institution - Standard care 12 months Cost to Institution as assessed using the In Person questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person, standard care appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
Cost to Institution - Team Clinic 12 months Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, Team Clinic care appointment. "Did you attend your in person appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
Cost to Institution - Clinic Costs 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 Institution - Team Costs 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 (e.g. role), "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for Team Clinic appointment; training on, "roles of the attendees," in Team Clinic. Issues regarding the study and study toolkit.
Diabetes Strengths and Resilience Measure for Children At 0 (baseline) and 12 months (after visit 4) DSTAR-Child assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.
Diabetes Strengths and Resilience Measure for Teens At 0 (baseline) and 12 months (after visit 4) DSTAR-Teen assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.
PROMIS - Emotional Support At 0 (baseline) and 12 months (after visit 4) Patient-Reported Outcomes Measurement Information System (PROMIS )- Emotional Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing perceived feelings of being cared for and valued as a person; having confidant relationships. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
PROMIS - Instrumental Support At 0 (baseline) and 12 months (after visit 4) Patient-Reported Outcomes Measurement Information System (PROMIS )- Instrumental Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of assistance with material, cognitive or task performance. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
PROMIS - Informational Support At 0 (baseline) and 12 months (after visit 4) Patient-Reported Outcomes Measurement Information System (PROMIS )- Informational Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of helpful information or advice.. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
PROMIS - Peds Peer Relationships At 0 (baseline) and 12 months (after visit 4) Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Peer Relationships. Evaluates and monitors social health. Likert scale used to assess quality of relationships with friends and acquaintances. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States