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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Behavioral: Patient Safety health information technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 18-99 years of age Exclusion Criteria: patients under age 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Patient safety technology toolkits on hospital care units<br>|
| No Intervention: Usual Care<br>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 |