Type 1 Diabetes Clinical Trial
Official title:
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Middle School and High School Adolescents and Young Adults With Type 1 Diabetes
Verified date | April 2024 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 79 |
Est. completion date | September 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | Inclusion 1. Diagnosis of type 1 diabetes > 6 month duration 2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention 3. Not currently participating in other group interventions 4. English speaking Exclusions 1. Severe behavioral or developmental disabilities in parent or child 2. Severe psychological diagnoses in parent or child that would make group participation difficult 3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease) 4. Non-English speaking |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | Cedars-Sinai Medical Center, University of Southern California |
United States,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Socio-Demographic History | Self-reported demographic history (gender, age, race, household income, etc) will be collected. | At 0 (baseline) | |
Other | Medical History | General health history via self report and EMR | 12 months | |
Other | Diabetes Treatment Regimen - glucometer | Diabetes treatment regimen assessed through blood glucose checks per day from glucometer downloads will be collected from devices and EMR. | 12 months | |
Other | Diabetes Treatment Regimen - insulin pump | Diabetes treatment regimen assessed through insulin boluses per day from insulin pump downloads will be collected from devices and EMR. | 12 months | |
Other | Diabetes Treatment Regimen - continuous glucose monitors | Diabetes treatment regimen assessed through percentage of glucose values low, in target, or high for patients on continuous glucose monitors will be collected from devices and EMR. | 12 months | |
Other | Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Other | The Child Health Utility | The Child Health Utility 9 dimensions assesses health-related quality of life (HRQoL). Multiple choice used to capture respondents' endorsement of particular statements about experience. "I don't feel [upset] today," "I feel a little bit [upset] today," "I feel a bit [upset] today," "I feel quite [upset] today," "I feel very [upset] today" | At 0 (baseline) and 12 months (after visit 4) | |
Other | Patient Health Questionnaire-8 (PHQ-8) | Composed of 8 items to screen, diagnose, and measure the severity of depression. | At 0 (baseline) and 12 months (after visit 4) | |
Other | Shared Medical Appointments - Patient/AYA | Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments. | baseline to 12 months | |
Other | Shared Medical Appointments- Parent/caregiver | Likert scale;"Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments. | baseline to 12 months | |
Other | Self Care - Related to Diabetes as assessed by Self-Care questionnaire | Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?" | baseline to 12 months | |
Other | Diabetes Family Responsbility Questionnaire - Parent | Asseses how adolescents with T1D and their families/caregivers share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management. | At 0 (baseline) and 12 months (after visit 4) | |
Other | Diabetes Family Responsbility Questionnaire - Teen | Asseses how parents/caregivers of children/teens living with T1D share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management. | At 0 (baseline) and 12 months (after visit 4) | |
Other | Clinical Variables | Polar; Yes or No questionnaire. Data extracted from EMR : cholesterol, high density lipoprotein, triglycerides, smoking status, nephropathy, microalbuminaria, macroalbuminaria, end-stage renal disease (death from end-stage renal disease), neuropathy, peripheral arterial disease (low extremity amputation), retinopathy (proliferative retinopathy), macular edema, blindness, angina, myocardial infarction, stroke, heart failure, revascularization (Coronary artery bypass grafting, PCA, and stenting). If answered "yes" for the following: ergosterol, HDL,microalbuminaria, and macroalbuminaria, values will be recorded. | At 0 (baseline) and 12 months (after visit 4) | |
Other | ADA and CCS standards | EMR abstraction: Questions assess compliance with ADA and CCS standards when patients have contact with all team members annually. This will be noted with polar questions "Yes" or No." This will be tracked for all patients in the study (e.g., Team Clinic and Standard Clinic). | 12 months | |
Other | Single Item Literacy Scale | Literacy assessed using the Single Item Literacy Scale. Multiple choice question asking about suppoort needed with reading materials. Options, "never," "rarely," "sometimes," "often," "always" | At 0 (Baseline) and 12 months (after visit 4) | |
Other | Provider Centered Care Observation Form (PCOF) | Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintain Relationship Throughout the Visit," "Collaborative upfront agenda setting," "Maintain Efficiency using transparent thinking and respectful interruption," "Gathering information," "Assessing patient or family perspective on health," "Electronic Medical Record Use," "Physical Exam" | 12 months | |
Other | Facilitator Centered Care Observation Form (PCOF) | Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintains Relationship Trhoughout the Visit," "Session Introduction and Icebreaker," "Session Preparation," "Gathering Information," "Assessing Patient or Family Persepctive on Health/Understanding Context," "Blood Glucose Charting," "Blood Glucose Discussion," "Activity Kit Review" | 12 months | |
Other | Provider/Facilitator Session Feedback Form: | Assess provider experience during clinic visit and patient-center delivery. Multiple choice, "Establishing Rapport and Maintaining Relationship," "Agenda-setting, Thinking Out-Loud, and Collaboration," "Gathering Information and Understanding Context," "EMR Review and Physical Exam," "Promoting Behavior Change or Self-Management," "Collaborative Planning and Closure," "None of these" | 12 months | |
Primary | Hemoglobin A1C at Baseline | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % | baseline to 12 months | |
Primary | Hemoglobin A1C Progression | HbA1c % At-Home Kit | At baseline (0), 3 months, 6 months, 9 months, 12 months | |
Primary | Number of Team Clinic Care cohort participants attending appointments | Attendance will be recorded for each Team Clinic visit | 12 months | |
Primary | Number of Virtual Team Clinic Care cohort participants completing appointments | Attendance will be recorded for each Virtual Team Clinic Visit | 12 months | |
Primary | Number of Team Clinic Care cohort participants completing appointments | Electronic Medical Record (EMR) Abstraction | 12 months | |
Primary | Patient and Provider/Clinic Staff 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 | |
Primary | Patient and Provider/Staff Satisfaction | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | Number of Standard Clinic cohort participants completing appointments | Attendance will be recorded for each standard care visit | 12 months | |
Primary | Number of Standard Care cohort participants completing appointments | Electronic Medical Record (EMR) Abstraction | 12 months | |
Secondary | Number of Team Clinic Care cohort participants with diabetic ketoacidosis | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR | 12 months | |
Secondary | Number of Standard Care cohort participants with diabetic ketoacidosis | Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR | 12 months | |
Secondary | Number of Team Clinic cohort participants with severe hypoglycemia | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR | 12 months | |
Secondary | Number of Standard Care cohort participants with severe hypoglycemia | Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR | 12 months | |
Secondary | Diabetes Family Conflict Scale | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | Problem Areas in Diabetes in Caregivers | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | Problem Areas in Diabetes in Teens | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | Patient - Practitioner Orientation Scale | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | Cost to Instituition | 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?" | 12 months | |
Secondary | Cost to Institution - Standard care | 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?" | 12 months | |
Secondary | Cost to Institution - Team Clinic | 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?" | 12 months | |
Secondary | Cost to Institution - Clinic Costs | 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. | 12 months | |
Secondary | Cost to Institution - Team Costs | 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. | 12 months | |
Secondary | Cost to Institution | 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." | 12 months | |
Secondary | Clinical Efficiency | 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. | 12 months | |
Secondary | Diabetes Strengths and Resilience Measure for Children | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | Diabetes Strengths and Resilience Measure for Teens | 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. | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | PROMIS - Peds Peer Relationships | 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) | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | PROMIS - Peds Family Relationships | 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) | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | PROMIS - Emotional Support | 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) | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | PROMIS - Instrumental Support | 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) | At 0 (baseline) and 12 months (after visit 4) | |
Secondary | PROMIS - Informational Support | 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) | At 0 (baseline) and 12 months (after visit 4) |
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