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Completed

NCT Number: NCT03161665

Patient and Caregiver Participation Through an Educational Health Information Technology System ("BMT Roadmap") in the Context of Hematopoietic Cell Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMT Roadmap

Other

The BMT Roadmap is a health IT System that has been developed for use on the Apple iPad® to give the patient and caregivers easy access to test results, current treatment and contact information to hopefully increase active participation and engagement in transplant care.

Primary outcomes

  1. Percentage of Caregivers Accrued

    Time frame: 5 months

    Feasibility of the study will be determined by demonstrating that accruing at least 20% of caregivers from the BMT patient population is possible.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 22, 2017
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.