An interventional study of Patient Safety health information technology in Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism and Patient Fall, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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.
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Exclusion Criteria:
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.
Behavioral: Patient Safety health information technology
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.
Patient safety technology toolkits on hospital care units
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
Time frame: up to 21 months
Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization
monitoring time for flags to change within patient safety information technology tools
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Processes of care: % patient-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
Processes of care: % 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
Processes of care: % 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
Processes of care: % 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
Processes of care: % patient-days without any diet order
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 21 months
Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered
Processes of care: % ordered pharmacologic prophylaxis doses administered
Time frame: up to 21 months
Pain Control: % pt-days with MED > 100 mg
Processes of care: % pt-days with MED \> 100 mg
Time frame: 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
Time frame: 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
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
Processes of care: % pt-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
Processes of care: % patient-days with patients on broad-spectrum antibiotics for \> 72 hours
Time frame: up to 21 months
Delirium Management: % patient-days Confusion Assessment Method (CAM) positive
Processes of care: % 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
Processes of care: % 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
Processes of care: % 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
Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics
Time frame: up to 21 months
Vascular Access: % patient-days with central line in place
Processes of care: % patient-days with central line in place
Time frame: up to 21 months
Foley Care: % patient-days with Foley catheter in place
Processes of care: % patient-days with Foley catheter in place
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Processes of care: % 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
Safety Outcomes: 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
Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days
Time frame: up to 21 months
Glucose Control: Patient-day-weighted mean glucose
Safety Outcomes: Patient-day-weighted mean glucose
Time frame: 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
Time frame: up to 21 months
Glucose Control: Proportion of patient-days with hypoglycemia
Safety Outcomes: Proportion of patient-days with hypoglycemia
Time frame: up to 21 months
Glucose Control: Proportion of patient-days with severe hypoglycemia
Safety Outcomes: Proportion of patient-days with severe hypoglycemia
Time frame: up to 21 months
Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE
Safety Outcomes: 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
Safety Outcomes: 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
Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 21 months
Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer
Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer
Time frame: 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
Time frame: up to 21 months
Delirium Management: proportion of hospitalizations requiring mechanical restraints
Safety outcomes: proportion of hospitalizations requiring mechanical restraints
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 21 months
Telemetry: proportion of hospitalizations for rapid response for arrhythmia
Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia
Time frame: up to 21 months
Provider perceptions of safety, communication based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey
perceived teamwork climate on hospital care units based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey
Time frame: up to 21 months
Patient activation, engagement, satisfaction based on Patient Activation Measure (PAM 13)
Patient and caregiver perceptions of how well clinical team kept them safe based on Patient Activation Measure (PAM 13)
Time frame: up to 21 months
Usability of tools/ technology based on Health iTues survey
usability of technology- ease of use based on Health iTues survey
Time frame: up to 21 months
Effects on workflow
cognitive burden based on direct observations
Time frame: up to 21 months
Adherence to PSLL patient safety information technology tools
use of tool by providers and patients
Time frame: up to 21 months
Health care utilization
Length of stay of patients
Time frame: up to 21 months
Patient Reported Safety Concerns- MySafeCare reporting tool
Rate of submissions into the MySafeCare reporting tool per 1000 patient days (confidence interval)
Time frame: up to 21 months
Proportion of hospitalizations with code blue or rapid response
Other Clinical Outcomes: Proportion of hospitalizations with cardio-respiratory code or rapid response
Time frame: up to 21 months
Proportion of hospitalizations with ICU transfer
Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer
Time frame: up to 21 months
Average time of discharge
time of discharge averaged
Time frame: up to 21 months
Patient Activation Measure (PAM-13)
Patient Activation as measured by the PAM 13 survey
Time frame: up to 21 months
30-day non-elective readmission
30-day non-elective readmission
Time frame: up to 21 months
Patient Satisfaction (HCAHPS)
Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
Time frame: up to 21 months
Plan to share: No
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