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(published and unpublished data).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.
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
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
- Participants will be recruited by BMT RN Coordinators and physicians prior to patient
admission to the Pediatric BMT Unit. Caregiver (age 18 years or older) of any patient
eligible to undergo autologous or allogeneic BMT and any patient (age 10 years or
older) eligible to undergo autologous or allogeneic BMT will be recruited during the
"Pre-Transplant Work-up" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be
hospitalized to undergo first-time autologous (self) or allogeneic (alternative
donor) BMT in the University of Michigan Mott Children's Hospital Pediatric BMT Unit.
The age range of patients typically transplanted in the Pediatric BMT unit is 0-25
years. 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
- PATIENT PARTICIPANTS: Patient (age 10 years or older) who will be hospitalized to
undergo first-time autologous or allogeneic BMT will be given the opportunity to
assent/consent and participate in the study. With his/her permission, the patient
will also be provided with their own iPad® BMT Roadmap information system to use.
Qualitative interviews will be conducted in patients (age 10 years or older) with
their assent/consent. However, patients (age 10-17.9 years) will not be asked to
complete surveys, because they have not been validated in this age group. Patients
(18 years or older) will be asked to complete surveys. The upper age limit is
typically 25 years on the Pediatric BMT Unit. This limit will be determined by only
those patients undergoing transplant in the Pediatric BMT Unit.
- 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.
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.