A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer, Blood Cancer, Lymphoma, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 10 - 75 |
| Updated: | 3/22/2019 |
| Start Date: | September 2015 |
| End Date: | May 2019 |
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.
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 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.
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.
Inclusion Criteria:
- 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
participate themselves.
- 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.
Exclusion Criteria:
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.
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