Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered

Not Applicable

Completed

• Conditions: Patient Fall; Severe Hospital Acquired Delerium; Central Line-Associated Bloodstream Infection (CLABSI); Rapid Response Related to Arrhythmia; Severe Hypoglycemia; Hospital Acquired Pressure Ulcer; Venous Thromboembolism; Catheter-Associated Infection; Opioid-Related Severe Adverse Drug Event; Adverse Drug Event
• Interventions: Behavioral: Patient Safety health information technology

• Registration Number: NCT02969343
• Lead Sponsor: Brigham and Women's Hospital

Brief 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 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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21000

Inclusion Criteria

• patients 18-99 years of age

Exclusion Criteria

• patients under age 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Patient Safety health information technology	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.

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes: Proportion of hospitalizations with any adverse event	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

Secondary Outcome Measures

Name	Time	Method
Vascular Access: % patient-days with central line in place	up to 21 months	Processes of care: % patient-days with central line in place
Foley Care: % patient-days with Foley catheter in place	up to 21 months	Processes of care: % patient-days with Foley catheter in place
Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order	up to 21 months	Processes of care: % patient-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization	up to 21 months	monitoring time for flags to change within patient safety information technology tools
Clinical Inertia:When Red flag, % changed to green during hospitalization	up to 21 months	monitoring time for flags to change within patient safety information technology tools
Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives	up to 21 months	Processes of care: % patient days of patients at fall risk due to a gait disturbance on sedatives
Nutrition: % pt-days NPO with insulin aspart ordered at same time	up to 21 months	Processes of care:% pt-days NPO with insulin aspart ordered at same time
Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications	up to 21 months	Processes of care: % patient-days with appropriate prophylaxis ordered based on risk and contraindications
Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours	up to 21 months	Processes of care: % patient-days with patients on broad-spectrum antibiotics for \> 72 hours
Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days	up to 21 months	monitoring time for flags to change within patient safety information technology tools
Clinical Inertia:Mean time to resolution of red flags (to green), days	up to 21 months	monitoring time for flags to change within patient safety information technology tools
Code Status: % patient-days on study unit with unconfirmed code status	up to 21 months	Processes of care: % patient-days on study unit with unconfirmed code status
Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin	up to 21 months	Processes of care: % patients with diabetes or hyperglycemia with order for basal insulin
Nutrition: % patient-days without any diet order	up to 21 months	Processes of care: % patient-days without any diet order
Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered	up to 21 months	Processes of care: % ordered pharmacologic prophylaxis doses administered
Pain Control: % pt-days with MED > 100 mg	up to 21 months	Processes of care: % pt-days with MED \> 100 mg
Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin	up to 21 months	Processes of care: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications	up to 21 months	Processes of care: % pt-days with appropriate prophylaxis administered based on risk and contraindications
Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered	up to 21 months	Processes of care: % patient-days with opioids ordered and no adjunctive medications ordered
Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded	up to 21 months	Processes of care: % pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours	up to 21 months	Processes of care: % pt-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for \> 72 hours
Delirium Management: % patient-days Confusion Assessment Method (CAM) positive	up to 21 months	Processes of care: % patient-days Confusion Assessment Method (CAM) positive
Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days	up to 21 months	Safety Outcomes: Patient Falls based on safety reports per 1000 patient-days
Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days	up to 21 months	Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days
Glucose Control: Patient-day-weighted mean glucose	up to 21 months	Safety Outcomes: Patient-day-weighted mean glucose
Delirium Management: % patient-days of patients at high risk for delirium on sedatives	up to 21 months	Processes of care: % patient-days of patients at high risk for delirium on sedatives
Delirium Management: % patient-days of patients at high risk for delirium on ramelteon	up to 21 months	Processes of care: % patient-days of patients at high risk for delirium on ramelteon
Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics	up to 21 months	Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics
Foley Care: % patient-days with Foley documented but not ordered	up to 21 months	Processes of care: % patient-days with Foley documented but not ordered
Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered	up to 21 months	Processes of care: % patient-days with Foley documented but NDP not ordered
Telemetry: % patient-days of high risk patients without any telemetry	up to 21 months	Processes of care: % patient-days of high risk patients without any telemetry bottom page 5 mock tables
Telemetry: % patient-days of low risk patients on telemetry > 72h	up to 21 months	Processes of care: % patient-days of low risk patients on telemetry \> 72h
Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered	up to 21 months	Processes of care: % pt-days of patients on opioids and no bowel regimen ordered
Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient	up to 21 months	Safety Outcomes: Proportion of glucose readings 70-180 mg/dL, mean per patient
Glucose Control: Proportion of patient-days with hypoglycemia	up to 21 months	Safety Outcomes: Proportion of patient-days with hypoglycemia
Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge	up to 21 months	Safety Outcomes: proportion of hospitalizations with VTE within 30 days of discharge
Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration	up to 21 months	Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration
Pain Control: proportion of hospitalizations of patients on opioids who required narcan	up to 21 months	Safety Outcomes: proportion of hospitalizations of patients on opioids who required narcan
Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered	up to 21 months	Processes of care: % patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
Glucose Control: Proportion of patient-days with severe hypoglycemia	up to 21 months	Safety Outcomes: Proportion of patient-days with severe hypoglycemia
Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE	up to 21 months	Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE
Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event	up to 21 months	Safety Outcomes: proportion of patients on opioids who had rapid response, code blue, ICU transfer, Bipap, mechanical ventilation
Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer	up to 21 months	Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer
Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event	up to 21 months	Safety Outcomes: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge	up to 21 months	Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer worsening in stage from admission to discharge
Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days	up to 21 months	Safety outcomes: Central Line Associate Urinary Tract Infection per 1000 patient-days
Delirium Management: proportion of hospitalizations requiring code gray and requiring security	up to 21 months	Safety outcomes: proportion of hospitalizations requiring code gray and requiring security
Delirium Management: proportion of hospitalizations requiring mechanical restraints	up to 21 months	Safety outcomes: proportion of hospitalizations requiring mechanical restraints
Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days	up to 21 months	Safety outcomes: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
Telemetry: proportion of hospitalizations for rapid response for arrhythmia	up to 21 months	Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States