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.
