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Rural Home Hospital: Proof of Concept

Information provided by:

Brigham and Women's Hospital

Last updated:

07/07/2021

Trial identifier:

NCT04531280

Disclaimer

Study Description

Brief summary:

This study examines the implications of providing hospital-level care in rural homes.

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Detailed Description:

Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments.
To further improve the model, the investigators propose to determine the feasibility of home hospital care in a rural home setting through a proof-of-concept approach.
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Official Title

Glossary term:

Title
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept

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Type of Study

Glossary term:

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 studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

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Enrollment (Actual)

Glossary term:

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

5

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Phase

Glossary term:

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): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Not Applicable

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Other Study ID Numbers

Glossary term:

Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

2020P000708

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Intervention / Treatment

Glossary term:

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.

Other: Home hospital care

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Study Start (Actual)

Glossary term:

Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Feb 18, 2021

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Primary Completion (Actual)

Glossary term:

Primary completion date
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 "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

May 07, 2021

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Study Completion (Actual)

Glossary term:

Study completion date
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 "estimated" study completion date is the date that the researchers think will be the study completion date.

May 07, 2021

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First Submitted Date

Glossary term:

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).

Aug 02, 2020

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First Submitted that Met QC Criteria

Glossary term:

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.

Aug 26, 2020

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First Posted (Actual)

Glossary term:

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.

Aug 28, 2020

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Last Update Submitted that Met MQ Criteria

Glossary term:

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.

Jul 06, 2021

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Last Update Posted (Actual)

Glossary term:

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.

Jul 07, 2021

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Other important Dates

Contacts and Locations

Locations (1)

Contacts and Locations

Locations (1)


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. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years +

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Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

No

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Sexes Eligible for Study:

Glossary term:

Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

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Description:

Patient clinical inclusion Criteria:

>=18 years old

Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection)

Heart failure exacerbation

Asthma and chronic obstructive pulmonary disease exacerbation

Atrial fibrillation with rapid ventricular response

Diabetes and its complications

Venous thromboembolism: This includes a patient who requires therapeutic anticoagulation and concomitant monitoring (thus requiring inpatient status)

Gout exacerbation

Chronic kidney disease with volume overload

Hypertensive urgency

End of life / desires only medical management: Regarding a patient who desires only medical management, this includes a patient who requires acute care for symptom management but declines any surgical intervention. This may include a patient who is about to transition to hospice care, for example, but still has the functional capacity to meet our criteria below. Under these circumstances, we would make sure that various contingencies, including possible transition to hospice care or hospital readmission, are completely understood by patients and caregivers as applicable.

Patient social inclusion criteria:

Lives in rural or ultra-rural area (see definitions in Appendix) that can be served by one of our RHH clinicians.

Has capacity to consent to study

Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient: This criterion maybe waived for highly competent patients at the patient and clinician's discretion.

Patient caregiver inclusion criteria: (not required for patient participation):

Age >= 18 years old

Has capacity to consent to study

Lives with or nearby to patient

Clinician inclusion criteria: Any member of the rural home hospital (RHH) clinical team (MD, RN, paramedic, NP) who will be participating in the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.

Patient Clinical Exclusion Criteria:

Acute delirium, as determined by the Confusion Assessment Method

Cannot establish peripheral access (or access requires ultrasound guidance, unless ultrasound guidance is available)

Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage

Primary diagnosis requires controlled substances

Cannot independently ambulate to bedside commode

As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery

For pneumonia: Most recent CURB65 > 3: new confusion, BUN > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65 (<14% 30-day mortality); Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90% (<10% chance of intensive respiratory or vasopressor support); Absence of clear infiltrate on imaging; Cavitary lesion on imaging; Pulmonary effusion of unknown etiology; O2 saturation < 90% despite 5L O2

For heart failure: Has a left ventricular assist device; GWTG-HF17 (>10% in-hospital mortality) or ADHERE18 (high risk or intermediate risk 1)*; Severe pulmonary hypertension

For complicated urinary tract infection: Absence of pyuria; Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)

For other infection: Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)

For COPD: BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% chance in-hospital mortality): exercise caution

For asthma: Peak expiratory flow < 50% of normal: exercise caution

For diabetes and its complications: Requires IV insulin

For hypertensive urgency: Systolic blood pressure > 190 mmHg; Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction

For atrial fibrillation with rapid ventricular response: Likely to require cardioversion; New atrial fibrillation with rapid ventricular response; Unstable blood pressure, respiratory rate, or oxygenation; Despite IV beta and/or calcium channel blockade in the emergency department, HR remains > 125 and SBP remains different than baseline; Less than 1 hour of time has elapsed with HR < 125 and SBP similar or higher than baseline

For patients with end-stage renal disease on peritoneal dialysis: Peritoneal catheter malfunction; Requires temporary hemodialysis

Home hospital census is full (maximum 3 patients at any time)

GWTG-HF: AHA Get with the Guidelines: SBP, BUN, Na, Age, HR, Black race, COPD ADHERE: Acute decompensated heart failure national registry: BUN, creatinine, SBP

Patient social exclusion criteria:

Non-english speaking

Undomiciled

No working heat (October-April), no working air conditioning if forecast > 80°F (June-September), or no running water

On methadone requiring daily pickup of medication

in police custody

Resides in facility that provides on-site medical care (e.g., skilled nursing facility)

Domestic violence screen positive


Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:
Primary Purpose:

Treatment

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Allocation:

N/A

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Interventional Model:

Single Group Assignment

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Number of Arms:

1

Arms and Interventions:

Participant Group / Arm

Glossary term:

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

Glossary term:

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: Home hospital care

Patients receive hospital-level care in their home, as a substitute to traditional hospital care.

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Experimental: Home hospital care

Patients receive hospital-level care in their home, as a substitute to traditional hospital care.

Other: Home hospital care

Patients receive hospital-level care in their home.

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Other: Home hospital care

Patients receive hospital-level care in their home.

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure
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

Rural home hospitalization accomplished

Measure Description

Completion of rural home hospitalization using a checklist to assess process completion on a scale of excellent, very good, good, fair, poor or does not apply.

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure
Measure Description
Timeframe

Rural home hospitalization accomplished

Completion of rural home hospitalization using a checklist to assess process completion on a scale of excellent, very good, good, fair, poor or does not apply.

Day of admission to day of discharge, estimated 10 days later

Secondary Outcome Measures

Glossary term:

Secondary outcome measure
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

3-item Care Transition Measure

Measure Description

This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient

Timeframe

Day of discharge to 7 days later

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Outcome Measure

Picker Experience Questionnaire

Measure Description

The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient

Timeframe

Day of discharge to 7 days later

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Outcome Measure

Global satisfaction: scale

Measure Description

Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient

Timeframe

Day of discharge to 7 days later

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Outcome Measure

Perceived acceptability of RHH care

Measure Description

Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.

Timeframe

Day of discharge to 30 days later

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Outcome Measure

Perceived safety, quality of care, caregiver burden

Measure Description

Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver.

Timeframe

Day of discharge to 30 days later

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Outcome Measure

Escalation of care to hospital

Measure Description

If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure

Adverse event

Measure Description

Adverse events include Fall, Delirium, Potentially preventable VTE, New pressure ulcer, Thrombophlebitis at peripheral IV site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure

Unplanned mortality during admission

Measure Description

Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure

Lab Orders, number

Measure Description

Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure

Length of stay

Measure Description

The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records

Timeframe

Day of admission to day of discharge, estimated 10 days later

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Outcome Measure

Unplanned readmission(s) after index, number and yes or no

Measure Description

Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient.

Timeframe

30-days post-discharge

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Outcome Measure

ED visit(s) after index, number and yes or no

Measure Description

Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient

Timeframe

30-days post-discharge

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Outcome Measure
Measure Description
Timeframe

3-item Care Transition Measure

This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient

Day of discharge to 7 days later

Picker Experience Questionnaire

The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient

Day of discharge to 7 days later

Global satisfaction: scale

Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient

Day of discharge to 7 days later

Perceived acceptability of RHH care

Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.

Day of discharge to 30 days later

Perceived safety, quality of care, caregiver burden

Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver.

Day of discharge to 30 days later

Escalation of care to hospital

If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Day of admission to day of discharge, estimated 10 days later

Adverse event

Adverse events include Fall, Delirium, Potentially preventable VTE, New pressure ulcer, Thrombophlebitis at peripheral IV site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Day of admission to day of discharge, estimated 10 days later

Unplanned mortality during admission

Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

Day of admission to day of discharge, estimated 10 days later

Lab Orders, number

Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records

Day of admission to day of discharge, estimated 10 days later

Length of stay

The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records

Day of admission to day of discharge, estimated 10 days later

Unplanned readmission(s) after index, number and yes or no

Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient.

30-days post-discharge

ED visit(s) after index, number and yes or no

Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient

30-days post-discharge


Sponsor and Collaborators

The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.

Sponsor:

Glossary term:

Sponsor
The organization or person who initiates the study and who has authority and control over the study.
  1. Brigham and Women's Hospital

Investigators and Collaborators

Investigators and Collaborators

Investigators:

Glossary term:

Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
    Central Contacts:
Overall Officials:
Collaborators:

Glossary term:

Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

More Information

Publications
Publications of Study Results
General Publications

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Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number

No publications available

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