Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

Large epidemiologic studies show that <25% of adolescents with type 1 diabetes (T1D) achieve
targeted glycohemoglobin levels advocated by the American Diabetes Association (< 7.5%) or
International Society of Pediatric and Adolescent Diabetes (< 7.0%). Optimal self-management
of T1D requires daily insulin replacement by multiple injections or insulin pump, 4-6 daily
blood glucose checks, regulation of carbohydrate intake and physical activity,
prevention/correction of glycemic fluctuations and perhaps use of a continuous glucose
monitor. This regimen places pervasive affective, behavioral, cognitive and social demands on
adolescents with T1D and their families and psychosocial variables greatly impact their
success in T1D self-care. Struggling with maintaining adequate glycemic control is
essentially normative among adolescents, suggesting that conventional systems of care are not
meeting the needs of this population. A substantial, growing literature provides an evidence
base for psychosocial screening and behavioral intervention strategies targeting improved
coping with the demands of T1D, but this evidence base has not penetrated fully into routine
T1D care. Rigorous integration of this evidence into routine care for T1D could yield many
benefits. Behavioral barriers to effective care are major concerns of all stakeholders, but
conventional care is not well-equipped to address these issues. Concomitantly, the supply of
board-certified pediatric endocrinologists is not keeping pace with growth of the T1D patient
population, amplifying the need to validate alternative delivery systems that multiply the
effective workforce of T1D health professionals. We will develop and test a novel
Transdisciplinary Care (TC) approach (conjoint TC visits conducted by an Advanced Practice
Nurse, Psychology Postdoctoral Fellow and Dietitian) to improve adolescents' T1D outcomes and
justify a larger randomized controlled trial (RCT). In Year 1, crowdsourcing methods will
engage youths with T1D, parents and health care providers (HCP) in planning a feasible,
acceptable, safe and effective TC model that addresses youths' and families' psychosocial
needs and capitalizes on the expertise of advanced practice nurses co-managing T1D with
psychologists and dietitians. The Wallander et al. stress and coping model and the D'Zurilla
and Goldfried problem solving model provide a sound conceptual framework for the TC model of
care. The TC team will learn each discipline's skills in T1D management, develop a detailed
TC manual to guide this work and others' future studies, see adolescents and parents together
as a team, screen for potentially modifiable psychological impediments to T1D care, and
promote families' coping resources by enhancing family-centered communication and problem
solving, implementing empirically validated behavioral interventions and facilitating
additional appropriate services for complex problems. Telehealth delivery of TC care carries
several potential advantages, justifying a rigorous RCT in Years 2-3 comparing the effects of
UC and of both Face-to-Face and Telehealth delivery of TC on glycemic control and treatment
adherence (primary outcomes) as well as quality of life and other psychosocial variables
(secondary outcomes). Qualitative and economic analyses will follow the RCT, providing
perspectives on mechanisms of TC effects and its sustainability. Mixed qualitative and
quantitative methods will validate an innovative model of T1D care for adolescents that could
then be tested in a future definitive, multi-site RCT. We will address these specific aims:

SPECIFIC AIM 1. In Year 1, with methods used effectively in our ongoing DP3 study of parents
of children <6 years old with T1D, we will engage separate "crowds" of adolescents with T1D,
parents, and HCPs in planning/refining a feasible, safe, acceptable and efficacious
Trans-Disciplinary care model (TC) for T1D in adolescence. This crowdsourcing effort should
yield a TC model that meets the needs of all key stakeholder groups, ensuring its
feasibility, acceptance and efficacy.

SPECIFIC AIM 2. With study oversight by a diverse stakeholder panel and guided by a detailed
intervention manual, 150 families of adolescents treated for T1D at Nemours practices in the
Delaware Valley or Florida will participate in a rigorous Randomized Controlled Trial (RCT)
in years 2 and 3. The RCT will compare Usual Care (UC) with Trans-Disciplinary Care delivered
in In-Person clinic visits (TC-IP) or via Telehealth (TC-TH) on glycohemoglobin (HbA1C),
treatment adherence, health care use, T1D-related distress, quality of life, and treatment
satisfaction. The proposed trial will yield substantial information that could justify a
definitive future test of this model, inform methodological planning for subsequent studies,
and determine if Telehealth or Face to Face delivery of TC would be more strongly justified
for evaluation in future trials.

SPECIFIC AIM 3. Qualitative interviews of adolescents, parents, and health care providers
completed at the midpoint and end of the RCT will identify possible mediators or moderators
of TC efficacy and guide refinements to the TC model. We will interview third party payers
about the feasibility of dissemination of the TC model into practice and collect health care
cost data. These analyses will strengthen the justification for a future, larger trial of TC,
and guide refinements to the TC model to further enhance its efficacy.

Adolescents:

- Age > 11 years but < 17 years at time of consent

- Diagnosis of Type 1 diabetes with duration of > 1 year

- Most recent HbA1C or mean HbA1C over the prior year 7.5-10.0%, inclusive

- Has had at least one clinic visit for T1D at a Nemours Children's Clinic within the
past year

- Is not currently participating in any other research in which treatment adherence or
glycemic control are study outcomes

- No T1D clinic visits in the preceding 12 months in which two or more care providers
saw the patient together

- Is not on daily oral glucocorticoid treatment

- Is considered developmentally normal by the treating clinician (not in a self-
contained special education classroom or been retained in 2 or more grades)

- Is able to read/comprehend study questionnaires in English

- Is not currently undergoing treatment for a coincident medical condition that, in the
opinion of the treating physician, represents a contraindication to study
participation

- Family must be able to access the internet

Parents:

- Is either a biological parent or legally appointed caregiver of the child

- Is the primary diabetes caregiver of the child: and at least weekly involvement in T1D
care

- Routinely accompanies child for diabetes care at Nemours

- Is willing to schedule T1D clinic visits at a specific available location in Orlando
or Wilmington

- Capable of participating in conversations in English during medical visits

- Anticipates continued medical care for T1D at Nemours for a year following study
enrollment

- Is able to read/comprehend study questionnaires and decision aids in English

- Does not have an open abuse/neglect case with any child protection agency over the
prior 3 years

- There is no evidence of frequent changes in the adolescent's household or living
arrangements