Clinical trial NCT02969343: Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
Official title: Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line-Associated Bloodstream Infection (CLABSI)
Venous Thromboembolism
Patient Fall
Catheter-Associated Infection
Severe Hypoglycemia
Opioid-Related Severe Adverse Drug Event
Hospital Acquired Pressure Ulcer
Adverse Drug Event
Severe Hospital Acquired Delerium
Rapid Response Related to Arrhythmia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Northeastern University
First posted: 2016-11-21
Enrollment: 21000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* patients 18-99 years of age

Exclusion Criteria:

* patients under age 18 years

Primary outcomes:
measure: Clinical Outcomes: Proportion of hospitalizations with any adverse event
timeFrame: up to 21 months
Secondary outcomes:
measure: Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization
timeFrame: up to 21 months
measure: Clinical Inertia:When Red flag, % changed to green during hospitalization
timeFrame: up to 21 months
measure: Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days
timeFrame: up to 21 months
measure: Clinical Inertia:Mean time to resolution of red flags (to green), days
timeFrame: up to 21 months
measure: Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives
timeFrame: up to 21 months
measure: Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order
timeFrame: up to 21 months
measure: Code Status: % patient-days on study unit with unconfirmed code status
timeFrame: up to 21 months
measure: Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin
timeFrame: up to 21 months
measure: Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin
timeFrame: up to 21 months
measure: Nutrition: % patient-days without any diet order
timeFrame: up to 21 months
measure: Nutrition: % pt-days NPO with insulin aspart ordered at same time
timeFrame: up to 21 months
measure: Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications
timeFrame: up to 21 months
measure: Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications
timeFrame: up to 21 months
measure: Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered
timeFrame: up to 21 months
measure: Pain Control: % pt-days with MED > 100 mg
timeFrame: up to 21 months
measure: Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered
timeFrame: up to 21 months
measure: Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded
timeFrame: up to 21 months
measure: Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours
timeFrame: up to 21 months
measure: Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours
timeFrame: up to 21 months
measure: Delirium Management: % patient-days Confusion Assessment Method (CAM) positive
timeFrame: up to 21 months
measure: Delirium Management: % patient-days of patients at high risk for delirium on sedatives
timeFrame: up to 21 months
measure: Delirium Management: % patient-days of patients at high risk for delirium on ramelteon
timeFrame: up to 21 months
measure: Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics
timeFrame: up to 21 months
measure: Vascular Access: % patient-days with central line in place
timeFrame: up to 21 months
measure: Foley Care: % patient-days with Foley catheter in place
timeFrame: up to 21 months
measure: Foley Care: % patient-days with Foley documented but not ordered
timeFrame: up to 21 months
measure: Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered
timeFrame: up to 21 months
measure: Telemetry: % patient-days of high risk patients without any telemetry
timeFrame: up to 21 months
measure: Telemetry: % patient-days of low risk patients on telemetry > 72h
timeFrame: up to 21 months
measure: Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered
timeFrame: up to 21 months
measure: Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered
timeFrame: up to 21 months
measure: Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days
timeFrame: up to 21 months
measure: Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days
timeFrame: up to 21 months
measure: Glucose Control: Patient-day-weighted mean glucose
timeFrame: up to 21 months
measure: Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient
timeFrame: up to 21 months
measure: Glucose Control: Proportion of patient-days with hypoglycemia
timeFrame: up to 21 months
measure: Glucose Control: Proportion of patient-days with severe hypoglycemia
timeFrame: up to 21 months
measure: Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE
timeFrame: up to 21 months
measure: Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge
timeFrame: up to 21 months
measure: Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration
timeFrame: up to 21 months
measure: Pain Control: proportion of hospitalizations of patients on opioids who required narcan
timeFrame: up to 21 months
measure: Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event
timeFrame: up to 21 months
measure: Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event
timeFrame: up to 21 months
measure: Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer
timeFrame: up to 21 months
measure: Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge
timeFrame: up to 21 months
measure: Delirium Management: proportion of hospitalizations requiring mechanical restraints
timeFrame: up to 21 months
measure: Delirium Management: proportion of hospitalizations requiring code gray and requiring security
timeFrame: up to 21 months
measure: Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days
timeFrame: up to 21 months
measure: Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days
timeFrame: up to 21 months
measure: Telemetry: proportion of hospitalizations for rapid response for arrhythmia
timeFrame: up to 21 months
Other outcomes:
measure: Provider perceptions of safety, communication based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey
timeFrame: up to 21 months
measure: Patient activation, engagement, satisfaction based on Patient Activation Measure (PAM 13)
timeFrame: up to 21 months
measure: Usability of tools/ technology based on Health iTues survey
timeFrame: up to 21 months
measure: Effects on workflow
timeFrame: up to 21 months
measure: Adherence to PSLL patient safety information technology tools
timeFrame: up to 21 months
measure: Health care utilization
timeFrame: up to 21 months
measure: Patient Reported Safety Concerns- MySafeCare reporting tool
timeFrame: up to 21 months
measure: Proportion of hospitalizations with code blue or rapid response
timeFrame: up to 21 months
measure: Proportion of hospitalizations with ICU transfer
timeFrame: up to 21 months
measure: Average time of discharge
timeFrame: up to 21 months
measure: Patient Activation Measure (PAM-13)
timeFrame: up to 21 months
measure: 30-day non-elective readmission
timeFrame: up to 21 months
measure: Patient Satisfaction (HCAHPS)
timeFrame: up to 21 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David W Bates, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.