Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered (PSLL)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 21000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients 18-99 years of age

Exclusion Criteria:

• patients under age 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Patient safety technology toolkits on hospital care units
No Intervention: Usual Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization	monitoring time for flags to change within patient safety information technology tools	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	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	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	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	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	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	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	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	up to 21 months
Nutrition: % patient-days without any diet order	Processes of care: % patient-days without any diet order	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	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	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	up to 21 months
Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered	Processes of care: % ordered pharmacologic prophylaxis doses administered	up to 21 months
Pain Control: % pt-days with MED > 100 mg	Processes of care: % pt-days with MED > 100 mg	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	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	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	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	up to 21 months
Delirium Management: % patient-days Confusion Assessment Method (CAM) positive	Processes of care: % patient-days Confusion Assessment Method (CAM) positive	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	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	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	up to 21 months
Vascular Access: % patient-days with central line in place	Processes of care: % patient-days with central line in place	up to 21 months
Foley Care: % patient-days with Foley catheter in place	Processes of care: % patient-days with Foley catheter in place	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	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	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	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	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	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	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	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	up to 21 months
Glucose Control: Patient-day-weighted mean glucose	Safety Outcomes: Patient-day-weighted mean glucose	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	up to 21 months
Glucose Control: Proportion of patient-days with hypoglycemia	Safety Outcomes: Proportion of patient-days with hypoglycemia	up to 21 months
Glucose Control: Proportion of patient-days with severe hypoglycemia	Safety Outcomes: Proportion of patient-days with severe hypoglycemia	up to 21 months
Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE	Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE	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	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	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	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	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	up to 21 months
Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer	Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer	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	up to 21 months
Delirium Management: proportion of hospitalizations requiring mechanical restraints	Safety outcomes: proportion of hospitalizations requiring mechanical restraints	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	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	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	up to 21 months
Telemetry: proportion of hospitalizations for rapid response for arrhythmia	Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia	up to 21 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	up to 21 months
Usability of tools/ technology based on Health iTues survey	usability of technology- ease of use based on Health iTues survey	up to 21 months
Effects on workflow	cognitive burden based on direct observations	up to 21 months
Adherence to PSLL patient safety information technology tools	use of tool by providers and patients	up to 21 months
Health care utilization	Length of stay of patients	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)	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	up to 21 months
Proportion of hospitalizations with ICU transfer	Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer	up to 21 months
Average time of discharge	time of discharge averaged	up to 21 months
Patient Activation Measure (PAM-13)	Patient Activation as measured by the PAM 13 survey	up to 21 months
30-day non-elective readmission	30-day non-elective readmission	up to 21 months
Patient Satisfaction (HCAHPS)	Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)	up to 21 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Northeastern University
• Investigators: Principal Investigator: David W Bates, MD MSc, Brigham and Women's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Skin Ulcer; Embolism and Thrombosis; Sepsis; Infections; Communicable Diseases; Hypoglycemia; Thromboembolism; Venous Thromboembolism; Drug-Related Side Effects and Adverse Reactions; Catheter-Related Infections; Pressure Ulcer
• Other Study ID Numbers: 5P30HS023535 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO