A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
Condition: Leukemia; Lymphoma; Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow
      transplantation (BMT), is a potentially life-saving therapy for many malignant and
      non-malignant conditions. Despite advances over the past decade, which have led to improved
      outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient-based
      care. While many patients endure the acute complications of the procedure, it is common for
      BMT patients and their caregivers to experience increased risk of financial and emotional
      burden, hospital readmission, and health service utilization. This highlights the importance
      of active involvement of BMT patients in their own health care (self-efficacy). For pediatric
      BMT patients, parents are the primary caregivers. As such, parental activation on behalf of
      the child (patient) plays a critical role in effective patient-parent-provider partnerships,
      which is increasingly recognized as the optimal model for health care delivery, particularly
      for those facing life-altering medical treatments. It is essential to develop effective
      strategies to enhance this partnership. Health information technology (IT)-mediated tools
      offer the potential to overcome constraints in health care delivery limited by provider time,
      complicated health information, and financial pressures. Significant gaps in knowledge exist
      on the use of health IT tools using low-cost and well-accepted delivery platforms in routine
      inpatient care, especially for high-risk or critically ill populations. The investigators
      hypothesize that a tablet-based tool displaying personal health information could provide a
      platform to promote caregiver (parent) activation and enhance health communication. In this
      clinical research study, the investigators will conduct a pilot study of an educational
      health IT system developed on a tablet (Apple iPad®) that the investigators refer to as a
      Personalized Engagement Tool (PET) or the "BMT Roadmap." The Apple iPad® was selected as the
      platform for delivery of the educational intervention given its ergonomic features. The
      implementation and evaluation of the BMT Roadmap information system in caregivers of children
      undergoing BMT have been based on the generation of user (caregivers and patients) needs that
      incorporated well-established user-centered design processes including qualitative and
      quantitative research methods (published and unpublished data). The assembled investigators
      represent a strong multidisciplinary team with complementary and integrated expertise who are
      well-poised to carry out the proposed research. The Protocol or Study Team includes pediatric
      BMT physicians, Center for Health Communications Research (CHCR) staff, health informaticist,
      biostatistician, and psychologist. This research study is innovative because it addresses a
      gap in the literature on the role of health IT in parent activation on behalf of the child in
      the inpatient setting of a high-risk BMT population. The BMT Roadmap information system
      provides a robust experimental framework for further testing the utility of other care
      components that relate to parent activation or participation and for potential adoption in
      other complex medical conditions. The new knowledge gained herein will thus contribute to the
      evidence base of how health IT improves health care quality and provide the basis of further
      study in a full-scale clinical trial.
    

Detailed description: 
      PROTOCOL SYNOPSIS Title A Pilot Study of Patient and Caregiver Participation through an
      Educational Health Information Technology System ("The BMT Roadmap") in the Context of
      Hematopoietic Cell Transplantation

      Objective To evaluate the usefulness and usability of a health information technology (IT)
      system ("The BMT Roadmap"). This educational system will be developed on an Apple iPad® with
      collaborators from the School of Information, Health Informatics, and the Center for Health
      Communications Research (CHCR). The BMT Roadmap will be used by caregivers of patients
      hospitalized for first-time autologous (self) or allogeneic (alternative donor) blood and
      marrow transplantation (BMT) as well as patients (age 10 years or older) who are hospitalized
      for first time autologous or allogeneic BMT. The investigators hypothesize that parents will
      use the BMT Roadmap to become more active participants on behalf of their child.

      The information system will consist of 5 modules personalized to the study participant's
      child: (1) laboratory studies, (2) medications, (3) clinical trials enrolled on, (4) health
      care providers (BMT physicians, 7 Mott Nurses, BMT NPs, coordinators, pharmacists,
      nutritionist, social worker), and (5) criteria for discharge.

      Sample Size Caregivers: The investigators aim to enroll 10 adult caregivers of patients (0-25
      years of age) undergoing autologous (self) or allogeneic BMT (alternative donor); and
      Patients: 10 patients (10 years of age or older) undergoing autologous or allogeneic BMT.
      This sample size was determined based on the patient demographics of the University of
      Michigan Pediatric BMT Program. The number of participants who meet eligibility is
      approximately 50 per year. The investigators plan to enroll approximately 2 adult caregivers
      and 2 patients per month for an estimated accrual time of 5 months. This study allows for
      concurrent enrollment in other trials.

      Study Design After signing an informed consent, participants will be provided with an Apple
      iPad®. Qualitative and quantitative research methods will be used to measure the study
      outcomes. There will be approximately 6-8 qualitative interviews per participant conducted
      periodically from pre-BMT until 100 days post-BMT. Additionally, 15-20 qualitative interviews
      will be conducted of BMT care providers, including physicians, nurses, pharmacists,
      nutritionists, social worker, and psychologist to evaluate their attitudes and perceptions of
      the BMT Roadmap information system. Quantitative survey instruments will only be administered
      to adult participants (age 18 years or older). Caregivers with children (patients) who are
      younger than 10 years of age may be eligible to participate even though their children are
      too young to assent or participate themselves.

      Inclusion Criteria Caregivers: Caregiver (age 18 years or older) of a patient (0-25 years of
      age) who is an inpatient undergoing autologous or allogeneic BMT; Patients: patient (10 years
      or older) who is inpatient undergoing autologous or allogeneic BMT. Ability to speak and read
      proficiently in English (the study's instruments have not been translated and validated in
      languages other than English); Willing and able to provide informed consent; Willing to
      comply with study procedures and reporting requirements.

      Treatment Plan This protocol is an educational intervention study (no more than minimal
      risk). It does not include treatment of an investigation agent treatment.

      Study Endpoints The primary outcome measures will be the usefulness and the usability of the
      BMT Roadmap information system. Secondary measures will include standard-of-care
      patient-related clinical outcomes (length of stay and risk of day 30 and 100 readmission,
      infections, transplant-related mortality, and survival).

      Data Analysis Descriptive statistics will be calculated for each survey instrument.
      Univariate analyses will be performed to assess associations between the instruments and
      demographic, social, and environmental characteristics of the parent (type of insurance,
      marital status, number of children in household), and disease-related characteristics of the
      patients.
    

Intervention name(s): Education information system
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hematopoietic cell transplantation; caregivers; health information technology; patient-centered care