Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will consist of a randomized controlled trial to test a novel Transdisciplinary
      Care (TC) model of delivery of care for type 1 diabetes in adolescence. Adolescents and their
      parents/caregivers (n=150) will be randomized to Usual Care or TC care in a 1:2 ratio.
      Approximately half of those in TC care will received TC in person and half will receive it
      through telehealth. TC visits will consist of conjoint management of T1D by a TC team
      consisting of an Advanced Practice Nurse, Dietitian and Psychologist who will see
      parent-adolescent dyads together within the same visit. TC team members have trained each
      other in their respective disciplines. Outcome measures include glycohemoglobin (HbA1c) and
      questionnaires assessing diabetes self management behaviors. Other ancillary/exploratory
      measures are also completed.
    

Detailed description: 
      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 its inclusion within a RCT comparing the effects of
      UC to TC delivered via various modalities on glycemic control and treatment adherence
      (primary outcomes) as well as quality of life and other psychosocial variables (exploratory
      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 on
      glycohemoglobin (HbA1C), treatment adherence, along with exploratory outcomes including
      health care use, T1D-related distress, quality of life, and treatment satisfaction. Delivery
      mode of Trans-Disciplinary Care will also be explored (e.g., Face-to-Face, Telehealth,
      Combined). The proposed trial will yield substantial information that could justify a
      definitive future test of this model, inform methodological planning for subsequent studies,
      and explore whether certain modes of delivery (e.g., Telehealth) are 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.
    

Intervention name(s): Usual Care; Transdisciplinary Care-In Person & Telehealth
Intervention type(s): Other; Behavioral
Intervention description(s): Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.; TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design randomizes participants to standard care or transdisciplinary care delivered through various modalities (in person; telehealth). Data collection occurs at 5 Time Points (0, 3, 6, 9 and 12 months).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment