Central Line-Associated Bloodstream Infection (CLABSI)PSLLNCT02969343
Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
A study testing Patient Safety health information technology in people with Central Line-Associated Bloodstream Infection (CLABSI) and Venous Thromboembolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism, Patient Fall
- What is being tested?
- Patient Safety health information technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients 18-99 years of age
Who cannot join
- patients under age 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.
Read the detailed description
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop systems approaches to integrating health information technology (HIT), stakeholder engagement mechanisms, and process design/engineering methods focused on patient safety, development and enhancement of tools, health care system interventions, and translation into practice. The three technological toolkits to be developed as part of the Patient Safety Learning Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage patients and their family caregivers in the design of HIT tools to prevent patient falls and related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication; and 3) MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and fosters a health system focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and systems engineering researchers, collaborating with patients and family for evolving and applying these approaches to adverse event prevention in hospitalized patients. In addition, a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems engineering approaches to develop and provide a system-wide methodology to aid in the successful implementation and improvement of Health Information Technology (HIT) tools and a model known as the Patient SatisfActive® will be developed, tested, and refined to create a culture of patient- and family-centered care.
- Conditions
- Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism, Patient Fall, Catheter-Associated Infection, Severe Hypoglycemia, Opioid-Related Severe Adverse Drug Event
- Being tested
- Patient Safety health information technology
- Medical subject headings
- Venous Thromboembolism, Catheter-Related Infections, Hypoglycemia, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Safety health information technologyBehavioural
Patient safety technology toolkits on hospital care units
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients and providers on hospital care units where the PSLL patient safety health information technology tools are implemented, during the interventional phase of a stepped wedge randomized trial design. Receives: Behavioral: Patient Safety health information technology |
| Usual Care | No intervention | Patients on hospital care units where the PSLL patient safety health information technology tools have been implemented or are to be implemented, but are not during the usual care phase of a stepped wedge randomized trial design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes: Proportion of hospitalizations with any adverse event
Hospitalizations with the presence of any of the following: Patient Falls with Injury, Severe Hypoglycemia, Inpatient or post hospitalization venous thromboembolism, catheter associated urinary tract infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), Opioid related severe adverse drug event, hospital acquired pressure ulcer, severe hospital acquired delirium, rapid response related to arrhythmia
Measured: up to 21 months
Secondary outcomes (50)
Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization
monitoring time for flags to change within patient safety information technology tools
Measured: up to 21 months
Clinical Inertia:When Red flag, % changed to green during hospitalization
monitoring time for flags to change within patient safety information technology tools
Measured: up to 21 months
Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days
monitoring time for flags to change within patient safety information technology tools
Measured: up to 21 months
Clinical Inertia:Mean time to resolution of red flags (to green), days
monitoring time for flags to change within patient safety information technology tools
Measured: up to 21 months
Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives
Processes of care: % patient days of patients at fall risk due to a gait disturbance on sedatives
Measured: up to 21 months
Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
Processes of care: % patient-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
Measured: up to 21 months
Code Status: % patient-days on study unit with unconfirmed code status
Processes of care: % patient-days on study unit with unconfirmed code status
Measured: up to 21 months
Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin
Processes of care: % patients with diabetes or hyperglycemia with order for basal insulin
Measured: up to 21 months
Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
Processes of care: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
Measured: up to 21 months
Nutrition: % patient-days without any diet order
Processes of care: % patient-days without any diet order
Measured: up to 21 months
Nutrition: % pt-days NPO with insulin aspart ordered at same time
Processes of care:% pt-days NPO with insulin aspart ordered at same time
Measured: up to 21 months
Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications
Processes of care: % patient-days with appropriate prophylaxis ordered based on risk and contraindications
Measured: up to 21 months
Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications
Processes of care: % pt-days with appropriate prophylaxis administered based on risk and contraindications
Measured: up to 21 months
Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered
Processes of care: % ordered pharmacologic prophylaxis doses administered
Measured: up to 21 months
Pain Control: % pt-days with MED > 100 mg
Processes of care: % pt-days with MED > 100 mg
Measured: up to 21 months
Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered
Processes of care: % patient-days with opioids ordered and no adjunctive medications ordered
Measured: up to 21 months
Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
Processes of care: % pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
Measured: up to 21 months
Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
Processes of care: % pt-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
Measured: up to 21 months
Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours
Processes of care: % patient-days with patients on broad-spectrum antibiotics for > 72 hours
Measured: up to 21 months
Delirium Management: % patient-days Confusion Assessment Method (CAM) positive
Processes of care: % patient-days Confusion Assessment Method (CAM) positive
Measured: up to 21 months
Delirium Management: % patient-days of patients at high risk for delirium on sedatives
Processes of care: % patient-days of patients at high risk for delirium on sedatives
Measured: up to 21 months
Delirium Management: % patient-days of patients at high risk for delirium on ramelteon
Processes of care: % patient-days of patients at high risk for delirium on ramelteon
Measured: up to 21 months
Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics
Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics
Measured: up to 21 months
Vascular Access: % patient-days with central line in place
Processes of care: % patient-days with central line in place
Measured: up to 21 months
Foley Care: % patient-days with Foley catheter in place
Processes of care: % patient-days with Foley catheter in place
Measured: up to 21 months
Foley Care: % patient-days with Foley documented but not ordered
Processes of care: % patient-days with Foley documented but not ordered
Measured: up to 21 months
Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered
Processes of care: % patient-days with Foley documented but NDP not ordered
Measured: up to 21 months
Telemetry: % patient-days of high risk patients without any telemetry
Processes of care: % patient-days of high risk patients without any telemetry bottom page 5 mock tables
Measured: up to 21 months
Telemetry: % patient-days of low risk patients on telemetry > 72h
Processes of care: % patient-days of low risk patients on telemetry > 72h
Measured: up to 21 months
Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered
Processes of care: % pt-days of patients on opioids and no bowel regimen ordered
Measured: up to 21 months
Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
Processes of care: % patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
Measured: up to 21 months
Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days
Safety Outcomes: Patient Falls based on safety reports per 1000 patient-days
Measured: up to 21 months
Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days
Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days
Measured: up to 21 months
Glucose Control: Patient-day-weighted mean glucose
Safety Outcomes: Patient-day-weighted mean glucose
Measured: up to 21 months
Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient
Safety Outcomes: Proportion of glucose readings 70-180 mg/dL, mean per patient
Measured: up to 21 months
Glucose Control: Proportion of patient-days with hypoglycemia
Safety Outcomes: Proportion of patient-days with hypoglycemia
Measured: up to 21 months
Glucose Control: Proportion of patient-days with severe hypoglycemia
Safety Outcomes: Proportion of patient-days with severe hypoglycemia
Measured: up to 21 months
Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE
Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE
Measured: up to 21 months
Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge
Safety Outcomes: proportion of hospitalizations with VTE within 30 days of discharge
Measured: up to 21 months
Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration
Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration
Measured: up to 21 months
Pain Control: proportion of hospitalizations of patients on opioids who required narcan
Safety Outcomes: proportion of hospitalizations of patients on opioids who required narcan
Measured: up to 21 months
Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event
Safety Outcomes: proportion of patients on opioids who had rapid response, code blue, ICU transfer, Bipap, mechanical ventilation
Measured: up to 21 months
Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
Safety Outcomes: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
Measured: up to 21 months
Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer
Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer
Measured: up to 21 months
Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge
Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer worsening in stage from admission to discharge
Measured: up to 21 months
Delirium Management: proportion of hospitalizations requiring mechanical restraints
Safety outcomes: proportion of hospitalizations requiring mechanical restraints
Measured: up to 21 months
Delirium Management: proportion of hospitalizations requiring code gray and requiring security
Safety outcomes: proportion of hospitalizations requiring code gray and requiring security
Measured: up to 21 months
Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
Safety outcomes: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
Measured: up to 21 months
Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days
Safety outcomes: Central Line Associate Urinary Tract Infection per 1000 patient-days
Measured: up to 21 months
Telemetry: proportion of hospitalizations for rapid response for arrhythmia
Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia
Measured: up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Line-Associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University
- Responsible party
- Principal investigator, David W. Bates, MD, MSc, Brigham and Women's Hospital
- Investigators
- David W Bates, MD MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969343
- Sponsor's protocol ID
- 5P30HS023535
- Acronym
- PSLL
- Status last verified
- Jul 2019
- First submitted
- 24 Oct 2016
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dykes PC, Burns Z, Adelman J, Benneyan J, Bogaisky M, Carter E, Ergai A, Lindros ME, Lipsitz SR, Scanlan M, Shaykevich S, Bates DW. Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025889. doi: 10.1001/jamanetworkopen.2020.25889.
PubMed 33201236
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
- ClinicalTrials.gov ID
- NCT02969343
- Acronym / sponsor ID
- PSLL / 5P30HS023535
- Conditions
- Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism, Patient Fall, Catheter-Associated Infection, Severe Hypoglycemia, Opioid-Related Severe Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Northeastern University
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Nov 2016 (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.
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.
Detailed description
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop systems approaches to integrating health information technology (HIT), stakeholder engagement mechanisms, and process design/engineering methods focused on patient safety, development and enhancement of tools, health care system interventions, and translation into practice. The three technological toolkits to be developed as part of the Patient Safety Learning Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage patients and their family caregivers in the design of HIT tools to prevent patient falls and related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication; and 3) MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and fosters a health system focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and systems engineering researchers, collaborating with patients and family for evolving and applying these approaches to adverse event prevention in hospitalized patients. In addition, a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems engineering approaches to develop and provide a system-wide methodology to aid in the successful implementation and improvement of Health Information Technology (HIT) tools and a model known as the Patient SatisfActive® will be developed, tested, and refined to create a culture of patient- and family-centered care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Patient Safety health information technologyPatients and providers on hospital care units where the PSLL patient safety health information technology tools are implemented, during the interventional phase of a stepped wedge randomized trial design. |
| Usual Care | No intervention | –Patients on hospital care units where the PSLL patient safety health information technology tools have been implemented or are to be implemented, but are not during the usual care phase of a stepped wedge randomized trial design. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients 18-99 years of age
Key exclusion criteria (1 listed)
- patients under age 18 years
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 |
|---|---|---|
| Patient Safety health information technologyPatient safety technology toolkits on hospital care units | Behavioural | Intervention |
Primary outcome
Clinical Outcomes: Proportion of hospitalizations with any adverse event
Time frame: up to 21 months
Hospitalizations with the presence of any of the following: Patient Falls with Injury, Severe Hypoglycemia, Inpatient or post hospitalization venous thromboembolism, catheter associated urinary tract infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), Opioid related severe adverse drug event, hospital acquired pressure ulcer, severe hospital acquired delirium, rapid response related to arrhythmia
50 secondary outcomes
Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization
Time frame: up to 21 months
Clinical Inertia:When Red flag, % changed to green during hospitalization
Time frame: up to 21 months
Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days
Time frame: up to 21 months
Clinical Inertia:Mean time to resolution of red flags (to green), days
Time frame: up to 21 months
Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives
Time frame: up to 21 months
Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
Time frame: up to 21 months
Code Status: % patient-days on study unit with unconfirmed code status
Time frame: up to 21 months
Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin
Time frame: up to 21 months
Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
Time frame: up to 21 months
Nutrition: % patient-days without any diet order
Time frame: up to 21 months
Nutrition: % pt-days NPO with insulin aspart ordered at same time
Time frame: up to 21 months
Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications
Time frame: up to 21 months
Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications
Time frame: up to 21 months
Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered
Time frame: up to 21 months
Pain Control: % pt-days with MED > 100 mg
Time frame: up to 21 months
Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered
Time frame: up to 21 months
Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
Time frame: up to 21 months
Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
Time frame: up to 21 months
Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours
Time frame: up to 21 months
Delirium Management: % patient-days Confusion Assessment Method (CAM) positive
Time frame: up to 21 months
Delirium Management: % patient-days of patients at high risk for delirium on sedatives
Time frame: up to 21 months
Delirium Management: % patient-days of patients at high risk for delirium on ramelteon
Time frame: up to 21 months
Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics
Time frame: up to 21 months
Vascular Access: % patient-days with central line in place
Time frame: up to 21 months
Foley Care: % patient-days with Foley catheter in place
Time frame: up to 21 months
Foley Care: % patient-days with Foley documented but not ordered
Time frame: up to 21 months
Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered
Time frame: up to 21 months
Telemetry: % patient-days of high risk patients without any telemetry
Time frame: up to 21 months
Telemetry: % patient-days of low risk patients on telemetry > 72h
Time frame: up to 21 months
Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered
Time frame: up to 21 months
Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
Time frame: up to 21 months
Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days
Time frame: up to 21 months
Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days
Time frame: up to 21 months
Glucose Control: Patient-day-weighted mean glucose
Time frame: up to 21 months
Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient
Time frame: up to 21 months
Glucose Control: Proportion of patient-days with hypoglycemia
Time frame: up to 21 months
Glucose Control: Proportion of patient-days with severe hypoglycemia
Time frame: up to 21 months
Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE
Time frame: up to 21 months
Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge
Time frame: up to 21 months
Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration
Time frame: up to 21 months
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 10 Jul 2019.
- Derived from this study: PubMed 33201236Dykes PC, Burns Z, Adelman J, Benneyan J, Bogaisky M, Carter E, Ergai A, Lindros ME, Lipsitz SR, Scanlan M, Shaykevich S, Bates DW. Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025889. doi: 10.1001/jamanetworkopen.2020.25889.
- Individual participant dataSharing planned: No
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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.
David W Bates, MD MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Safety health information technology in people with Central Line-Associated Bloodstream Infection (CLABSI) and Venous Thromboembolism, run by Brigham and Women's Hospital 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 1 inclusion and 1 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 10 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?
Clinical Outcomes: Proportion of hospitalizations with any adverse event (time frame: up to 21 months). 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 NCT02969343, which also lists 1 linked publication.
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 10 Jul 2019.