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

Venous Thromboembolism Clinical Trial

— PSLL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969343
• Other study ID #: 5P30HS023535
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patients 18-99 years of age

Exclusion Criteria:

• patients under age 18 years

Related Conditions & MeSH terms

• Adverse Drug Event
• Catheter-Associated Infection
• Catheter-Related Infections
• Central Line-Associated Bloodstream Infection (CLABSI)
• Communicable Diseases
• Drug-Related Side Effects and Adverse Reactions
• Hospital Acquired Pressure Ulcer
• Hypoglycemia
• Infection
• Opioid-Related Severe Adverse Drug Event
• Patient Fall
• Pressure Ulcer
• Rapid Response Related to Arrhythmia
• Severe Hospital Acquired Delerium
• Severe Hypoglycemia
• Thromboembolism
• Venous Thromboembolism

Intervention

Behavioral:
• Patient Safety health information technology
Patient safety technology toolkits on hospital care units

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Usability of tools/ technology based on Health iTues survey	usability of technology- ease of use based on Health iTues survey	up to 21 months
Other	Effects on workflow	cognitive burden based on direct observations	up to 21 months
Other	Adherence to PSLL patient safety information technology tools	use of tool by providers and patients	up to 21 months
Other	Health care utilization	Length of stay of patients	up to 21 months
Other	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
Other	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
Other	Proportion of hospitalizations with ICU transfer	Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer	up to 21 months
Other	Average time of discharge	time of discharge averaged	up to 21 months
Other	Patient Activation Measure (PAM-13)	Patient Activation as measured by the PAM 13 survey	up to 21 months
Other	30-day non-elective readmission	30-day non-elective readmission	up to 21 months
Other	Patient Satisfaction (HCAHPS)	Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)	up to 21 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Nutrition: % patient-days without any diet order	Processes of care: % patient-days without any diet order	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered	Processes of care: % ordered pharmacologic prophylaxis doses administered	up to 21 months
Secondary	Pain Control: % pt-days with MED > 100 mg	Processes of care: % pt-days with MED > 100 mg	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Delirium Management: % patient-days Confusion Assessment Method (CAM) positive	Processes of care: % patient-days Confusion Assessment Method (CAM) positive	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Vascular Access: % patient-days with central line in place	Processes of care: % patient-days with central line in place	up to 21 months
Secondary	Foley Care: % patient-days with Foley catheter in place	Processes of care: % patient-days with Foley catheter in place	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Glucose Control: Patient-day-weighted mean glucose	Safety Outcomes: Patient-day-weighted mean glucose	up to 21 months
Secondary	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
Secondary	Glucose Control: Proportion of patient-days with hypoglycemia	Safety Outcomes: Proportion of patient-days with hypoglycemia	up to 21 months
Secondary	Glucose Control: Proportion of patient-days with severe hypoglycemia	Safety Outcomes: Proportion of patient-days with severe hypoglycemia	up to 21 months
Secondary	Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE	Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer	Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer	up to 21 months
Secondary	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
Secondary	Delirium Management: proportion of hospitalizations requiring mechanical restraints	Safety outcomes: proportion of hospitalizations requiring mechanical restraints	up to 21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Telemetry: proportion of hospitalizations for rapid response for arrhythmia	Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia	up to 21 months