Patients Undergoing Bone Marrow Transplant (BMT) Clinical Trial
Official title:
A Pilot Study of Patient and Caregiver Participation Through an Educational Health Information Technology System ("BMT Roadmap") in the Context of Hematopoietic Cell Transplantation (Adult Protocol)
| Verified date | November 2017 |
| Source | University of Michigan Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
Given the intense nature of BMT, however, caregivers also play a critical role in the process
and are a necessary component of proceeding with transplant. As such, caregiver activation on
behalf of the patient plays a critical role in effective patient--caregiver-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. We
hypothesize that a tablet--based tool displaying personal health information could provide a
platform to promote caregiver activation and enhance health communication.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 6, 2017 |
| Est. primary completion date | January 6, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Participants will be recruited by BMT RN Coordinators and physicians prior to patient admission to the BMT Unit. Caregiver (age 18 years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age 18 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 BMT Unit - PATIENT PARTICIPANTS: Patients (age 18 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 with their assent/consent. - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Caregivers Accrued | Feasibility of the study will be determined by demonstrating that accruing at least 20% of caregivers from the BMT patient population is possible. | 5 months |