LeukemiaNCT02409121
A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
A study testing Education information system in people with Leukemia and Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Lymphoma, Brain Tumor
- What is being tested?
- Education information system
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 9 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Leukemia, Lymphoma, Brain Tumor
- Being tested
- Education information system
- Keywords
- hematopoietic cell transplantation, caregivers, health information technology, patient-centered care
- Medical subject headings
- Leukemia, Lymphoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education information systemBehavioural
Participants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | All participants will receive a tablet educational intervention (health IT platform) during the patient inpatient hospitalization for autologous or allogeneic transplant Receives: Behavioral: Education information system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who participate in the health information technology educational intervention
feasibility of recruitment and retention
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startSep 2015
- Primary completion9 Dec 2018
- Study completion9 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409121
- Sponsor's protocol ID
- UMCC 2015.050
- Other IDs
- HUM00100126
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fauer AJ, Hoodin F, Lalonde L, Errickson J, Runaas L, Churay T, Seyedsalehi S, Warfield C, Chappell G, Brookshire K, Chaar D, Shin JY, Byrd M, Magenau J, Hanauer DA, Choi SW. Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Support Care Cancer. 2019 Jun;27(6):2103-2112. doi: 10.1007/s00520-018-4450-4. Epub 2018 Sep 20.
PubMed 30232587Maher M, Kaziunas E, Ackerman M, Derry H, Forringer R, Miller K, O'Reilly D, An LC, Tewari M, Hanauer DA, Choi SW. User-Centered Design Groups to Engage Patients and Caregivers with a Personalized Health Information Technology Tool. Biol Blood Marrow Transplant. 2016 Feb;22(2):349-358. doi: 10.1016/j.bbmt.2015.08.032. Epub 2015 Sep 5.
PubMed 26343948
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
- ClinicalTrials.gov ID
- NCT02409121
- Acronym / sponsor ID
- UMCC 2015.050
- Conditions
- Leukemia, Lymphoma, Brain Tumor
- Keywords
- hematopoietic cell transplantation, caregivers, health information technology, patient-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2015
- Primary completion
- 9 Dec 2018 (actual)
- Study completion
- 9 Dec 2018 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Behavioral: Education information systemAll participants will receive a tablet educational intervention (health IT platform) during the patient inpatient hospitalization for autologous or allogeneic transplant |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education information systemParticipants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization | Behavioural | Open label |
Primary outcome
Number of subjects who participate in the health information technology educational intervention
Time frame: 100 days
feasibility of recruitment and retention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 30232587Fauer AJ, Hoodin F, Lalonde L, Errickson J, Runaas L, Churay T, Seyedsalehi S, Warfield C, Chappell G, Brookshire K, Chaar D, Shin JY, Byrd M, Magenau J, Hanauer DA, Choi SW. Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Support Care Cancer. 2019 Jun;27(6):2103-2112. doi: 10.1007/s00520-018-4450-4. Epub 2018 Sep 20.
- Derived from this study: PubMed 26343948Maher M, Kaziunas E, Ackerman M, Derry H, Forringer R, Miller K, O'Reilly D, An LC, Tewari M, Hanauer DA, Choi SW. User-Centered Design Groups to Engage Patients and Caregivers with a Personalized Health Information Technology Tool. Biol Blood Marrow Transplant. 2016 Feb;22(2):349-358. doi: 10.1016/j.bbmt.2015.08.032. Epub 2015 Sep 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education information system in people with Leukemia and Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who participate in the health information technology educational intervention (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409121, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.