Medical Home Care for Hematopoietic Stem Cell Transplantation Phase 2

February 6, 2024 updated by: Duke University

Patient-Centered Medical Home Care for Hematopoietic Stem Cell Transplantation: A Randomized Phase 2 Study

Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of malignant and non-malignant diseases. However, it is associated with significant morbidity, and treatment-related mortality. This is due in large part to the prolonged pancytopenia and immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation and the wait until engraftment of the transplanted hematopoietic stem cells. During this vulnerable period, infectious complications are common. Historically HCT patients were kept in protected environments to safeguard their health during the pancytopenic phase; despite these measures, infectious complications and graft versus host disease (GVHD) remained common and lead to significant morbidity and mortality after HCT. Currently patients are still closely watched in the inpatient or day hospital environment, though recent practices allow patients more freedom. This study randomizes eligible patients to receive post-transplant care at home vs. in the hospital or clinic, per standard of care. The primary objective is to compare the incidence of grade II-IV acute GVHD at 6 months in patients receiving patient-centered medical home (PCMH) vs standard care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patient-centered medical home (PCMH) is an exciting strategy that has the potential to revolutionize hematopoietic stem cell transplantation (HCT). Traditionally, home care has been used for palliative care in end-stage cancer patients and in geriatrics. More recently the PCMH has gained increasing adoption for both primary care and care of medically complex patients. The core of the PCMH lies in the interaction between the healthcare team, the patient's family and support, and above all, the patient. These interactions can be enhanced through health information technologies such as the electronic health record (EHR) and videoconferencing via iPads. In addition, collection of patient reported outcomes (PRO) will allow feedback and adjustments.

This integration is especially important when considering the multiple complicated needs of the HCT patient: navigating a Byzantine healthcare system that often requires input and coordination from multiple specialists including transplanters, hematologists, infectious disease physicians, gastroenterologists, psychiatrists, nutritionists, pharmacists, social workers, financial coordinators, etc.; managing medication regimens to prevent infections, GVHD, and other complications (not to mention avoiding drug and food interactions); adjusting to multiple side effects including fatigue, weakness, anorexia, nausea, vomiting, diarrhea, rashes, pain, anxiety, stress, organ failure, etc.; the sheer amount of time required for healthcare visits, lab draws, waiting for results, infusions, transfusions, etc.; physical and psychosocial struggles of living with a life-threatening disease; and the burdens of a treatment that often seems as debilitating as the disease. The PCMH provides patient-centered, comprehensive, accessible, and coordinated care and a systems-based approach to quality and safety: these attributes are essential to the successful care of the complicated HCT patient. this approach has the potential to lower overall costs while preserving or increasing the quality of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Adult Bone Marrow Transplant Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Scheduled to undergo a hematopoietic stem cell transplant for any cancer or non-cancer illness
  2. Age 18-80 years of age
  3. Karnofsky Performance Scale (KPS)> 80
  4. A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke

Exclusion Criteria:

  1. Lack of a caregiver
  2. Pregnant women
  3. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
  4. Use of homeopathic medications or probiotics that may impact gut microbiota

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient-Centered Medical Home (PCMH)

Day-to-Day Care:

Advanced Practice Providers (APP) will travel to subjects' homes in the morning, where they will perform the same daily assessment as standard care. They will draw labs and bring them back to the hospital for processing. When results are available, a second home visit is made to deliver necessary interventions. Subjects will have internet access through cellular-networked iPads and have daily videoconferences with their physicians. Daily follow up at home will continue until discharge as per above criteria.

Caregivers: identified by the subject as the person taking primary care of them will answer surveys and also collect stool samples to analyze in conjunction with those from subjects.
Other: Patient-Centered Medical Home (PCMH)
Subjects will receive their conditioning chemotherapy +/- radiation and stem cells in the hospital or day hospital, after which they will receive care during the neutropenic/recovery period at home. Advanced Practice Providers (APP) will travel to subjects' homes in the morning, where they will perform the same daily assessment as standard care. They will draw labs and bring them back to the hospital for processing. When results are available, a second home visit is made to deliver necessary interventions. Subjects will have internet access through cellular-networked iPads and have daily videoconferences with their physicians. Daily follow up at home will continue until discharge as per above criteria.
Active Comparator: Standard Care

These subjects will begin as inpatients or outpatients, where advanced practice providers (APPs) (nurse practitioners and physician assistants) will perform histories and physical exams. Nurses will collect labs and providers will enter orders in our electronic health record (EHR). All steps will be repeated daily until discharge to home. Suitability for discharge is determined by standard clinical criteria including stable blood counts, freedom from active or severe complications (e.g. active infection, severe GVHD), and ability to care for self.

Caregivers: identified by the subject as the person taking primary care of them will answer surveys and also collect stool samples to analyze in conjunction with those from subjects.
Other: Standard Care
Subjects will receive their conditioning chemotherapy +/- radiation and stem cells in the hospital or day hospital, after which they will receive care during the neutropenic/recovery period inpatient or outpatient. Advanced practice providers (APPs) will perform histories and physical exams. Nurses will collect labs and inpatient rounds occur twice daily, or for outpatients receiving care through our outpatient clinics, a healthcare provider typically sees them daily for the first month following transplant or discharge from the day hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute Graft Versus Host Disease (aGVHD)
Time Frame: 6 months
The primary endpoint is the incidence (number of events) of grade II-IV acute GVHD at 6 months. GVHD will be evaluated daily by advanced practice providers (APPs) according to standard criteria. The investigators will compare GVHD incidence rates between treatment arms using survival type regression modeling that takes competing risks into account. They will examine cause-specific Cox proportional hazards models as well as the proportional subdistribution hazard regression model developed by Fine and Gray. While the primary treatment comparison will be unadjusted, adjustment for covariates to explore the impact of various risk factors will also be performed.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Infection
Time Frame: 1 year
Rates of bacterial, fungal, and viral infections as well as overall infections at one year.
1 year
Disease Free Survival (DFS)
Time Frame: 1 year
Disease free survival at one year.
1 year
Overall Survival
Time Frame: 1 year
Overall survival at one year.
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Gut Microbiota
Time Frame: 6 months
Shannon diversity index will be compared using unpaired two-sided Student's t tests with a more stringent cut-off of 0.0125 given multiple comparisons, by the Bonferroni correction for 4 time periods of independent comparisons. Comparisons of bacterial populations will be made by using the Adonis non-parametric method from within the Qiime package using UnifFrac distance matrices from the populations being compared. P values will be calculated with α= 0.05. Metastatistics will be used for further statistical analyses of population structure, membership, and diversity with metadata such as time from transplant and dietary measurements such as caloric intake. Changes in specific bacterial families of interest will be compared using a two-sided Student's t test, with normality confirmed by D'Agostino and Pearson omnibus test with p≤0.05. All other comparisons will be done using two-sided Mann-Whitney tests.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nelson J C, MD, MBA, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00051024
  • R01CA203950-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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