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Completed

NCT Number: NCT02969343

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients 18-99 years of age

Exclusion criteria

  • patients under age 18 years

Treatment and study plan

Patient Safety health information technology

Behavioral

Patient safety technology toolkits on hospital care units

Primary outcomes

  1. Clinical Outcomes: Proportion of hospitalizations with any adverse event

    Time frame: 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 outcomes

  1. Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization

    Time frame: up to 21 months

    monitoring time for flags to change within patient safety information technology tools

  2. Clinical Inertia:When Red flag, % changed to green during hospitalization

    Time frame: up to 21 months

    monitoring time for flags to change within patient safety information technology tools

  3. Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days

    Time frame: up to 21 months

    monitoring time for flags to change within patient safety information technology tools

  4. Clinical Inertia:Mean time to resolution of red flags (to green), days

    Time frame: up to 21 months

    monitoring time for flags to change within patient safety information technology tools

  5. Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives

    Time frame: up to 21 months

    Processes of care: % patient days of patients at fall risk due to a gait disturbance on sedatives

  6. Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order

    Time frame: up to 21 months

    Processes of care: % patient-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order

  7. Code Status: % patient-days on study unit with unconfirmed code status

    Time frame: up to 21 months

    Processes of care: % patient-days on study unit with unconfirmed code status

  8. Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin

    Time frame: up to 21 months

    Processes of care: % patients with diabetes or hyperglycemia with order for basal insulin

  9. Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin

    Time frame: up to 21 months

    Processes of care: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin

  10. Nutrition: % patient-days without any diet order

    Time frame: up to 21 months

    Processes of care: % patient-days without any diet order

  11. Nutrition: % pt-days NPO with insulin aspart ordered at same time

    Time frame: up to 21 months

    Processes of care:% pt-days NPO with insulin aspart ordered at same time

  12. Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications

    Time frame: up to 21 months

    Processes of care: % patient-days with appropriate prophylaxis ordered based on risk and contraindications

  13. Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications

    Time frame: up to 21 months

    Processes of care: % pt-days with appropriate prophylaxis administered based on risk and contraindications

  14. Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered

    Time frame: up to 21 months

    Processes of care: % ordered pharmacologic prophylaxis doses administered

  15. Pain Control: % pt-days with MED > 100 mg

    Time frame: up to 21 months

    Processes of care: % pt-days with MED > 100 mg

  16. Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered

    Time frame: up to 21 months

    Processes of care: % patient-days with opioids ordered and no adjunctive medications ordered

  17. Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded

    Time frame: up to 21 months

    Processes of care: % pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded

  18. Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours

    Time frame: 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

  19. Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours

    Time frame: up to 21 months

    Processes of care: % patient-days with patients on broad-spectrum antibiotics for > 72 hours

  20. Delirium Management: % patient-days Confusion Assessment Method (CAM) positive

    Time frame: up to 21 months

    Processes of care: % patient-days Confusion Assessment Method (CAM) positive

  21. Delirium Management: % patient-days of patients at high risk for delirium on sedatives

    Time frame: up to 21 months

    Processes of care: % patient-days of patients at high risk for delirium on sedatives

  22. Delirium Management: % patient-days of patients at high risk for delirium on ramelteon

    Time frame: up to 21 months

    Processes of care: % patient-days of patients at high risk for delirium on ramelteon

  23. Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics

    Time frame: up to 21 months

    Processes of care: % patient-days of patients with hyperactive delirium on neuroleptics

  24. Vascular Access: % patient-days with central line in place

    Time frame: up to 21 months

    Processes of care: % patient-days with central line in place

  25. Foley Care: % patient-days with Foley catheter in place

    Time frame: up to 21 months

    Processes of care: % patient-days with Foley catheter in place

  26. Foley Care: % patient-days with Foley documented but not ordered

    Time frame: up to 21 months

    Processes of care: % patient-days with Foley documented but not ordered

  27. Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered

    Time frame: up to 21 months

    Processes of care: % patient-days with Foley documented but NDP not ordered

  28. Telemetry: % patient-days of high risk patients without any telemetry

    Time frame: up to 21 months

    Processes of care: % patient-days of high risk patients without any telemetry bottom page 5 mock tables

  29. Telemetry: % patient-days of low risk patients on telemetry > 72h

    Time frame: up to 21 months

    Processes of care: % patient-days of low risk patients on telemetry > 72h

  30. Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered

    Time frame: up to 21 months

    Processes of care: % pt-days of patients on opioids and no bowel regimen ordered

  31. Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered

    Time frame: up to 21 months

    Processes of care: % patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered

  32. Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days

    Time frame: up to 21 months

    Safety Outcomes: Patient Falls based on safety reports per 1000 patient-days

  33. Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days

    Time frame: up to 21 months

    Safety Outcomes: Falls with injury based on safety reports per 1000 patient-days

  34. Glucose Control: Patient-day-weighted mean glucose

    Time frame: up to 21 months

    Safety Outcomes: Patient-day-weighted mean glucose

  35. Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient

    Time frame: up to 21 months

    Safety Outcomes: Proportion of glucose readings 70-180 mg/dL, mean per patient

  36. Glucose Control: Proportion of patient-days with hypoglycemia

    Time frame: up to 21 months

    Safety Outcomes: Proportion of patient-days with hypoglycemia

  37. Glucose Control: Proportion of patient-days with severe hypoglycemia

    Time frame: up to 21 months

    Safety Outcomes: Proportion of patient-days with severe hypoglycemia

  38. Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE

    Time frame: up to 21 months

    Safety Outcomes: proportion of hospitalizations with hospital-acquired VTE

  39. Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge

    Time frame: up to 21 months

    Safety Outcomes: proportion of hospitalizations with VTE within 30 days of discharge

  40. Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration

    Time frame: up to 21 months

    Safety Outcomes: proportion of hospitalizations with opioid induced depression of consciousness or respiration

  41. Pain Control: proportion of hospitalizations of patients on opioids who required narcan

    Time frame: up to 21 months

    Safety Outcomes: proportion of hospitalizations of patients on opioids who required narcan

  42. Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event

    Time frame: up to 21 months

    Safety Outcomes: proportion of patients on opioids who had rapid response, code blue, ICU transfer, Bipap, mechanical ventilation

  43. Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event

    Time frame: up to 21 months

    Safety Outcomes: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event

  44. Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer

    Time frame: up to 21 months

    Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer

  45. Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge

    Time frame: up to 21 months

    Safety outcomes: proportion of hospitalizations with hospital-acquired pressure ulcer worsening in stage from admission to discharge

  46. Delirium Management: proportion of hospitalizations requiring mechanical restraints

    Time frame: up to 21 months

    Safety outcomes: proportion of hospitalizations requiring mechanical restraints

  47. Delirium Management: proportion of hospitalizations requiring code gray and requiring security

    Time frame: up to 21 months

    Safety outcomes: proportion of hospitalizations requiring code gray and requiring security

  48. Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days

    Time frame: up to 21 months

    Safety outcomes: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days

  49. Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days

    Time frame: up to 21 months

    Safety outcomes: Central Line Associate Urinary Tract Infection per 1000 patient-days

  50. Telemetry: proportion of hospitalizations for rapid response for arrhythmia

    Time frame: up to 21 months

    Safety outcomes: proportion of hospitalizations for rapid response for arrhythmia

Other outcomes

  1. Provider perceptions of safety, communication based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey

    Time frame: up to 21 months

    perceived teamwork climate on hospital care units based on Agency for Healthcare Research and Quality (AHRQ) patient safety climate survey

  2. Patient activation, engagement, satisfaction based on Patient Activation Measure (PAM 13)

    Time frame: up to 21 months

    Patient and caregiver perceptions of how well clinical team kept them safe based on Patient Activation Measure (PAM 13)

  3. Usability of tools/ technology based on Health iTues survey

    Time frame: up to 21 months

    usability of technology- ease of use based on Health iTues survey

  4. Effects on workflow

    Time frame: up to 21 months

    cognitive burden based on direct observations

  5. Adherence to PSLL patient safety information technology tools

    Time frame: up to 21 months

    use of tool by providers and patients

  6. Health care utilization

    Time frame: up to 21 months

    Length of stay of patients

  7. Patient Reported Safety Concerns- MySafeCare reporting tool

    Time frame: up to 21 months

    Rate of submissions into the MySafeCare reporting tool per 1000 patient days (confidence interval)

  8. Proportion of hospitalizations with code blue or rapid response

    Time frame: up to 21 months

    Other Clinical Outcomes: Proportion of hospitalizations with cardio-respiratory code or rapid response

  9. Proportion of hospitalizations with ICU transfer

    Time frame: up to 21 months

    Other Clinical Outcomes: Proportion of hospitalizations with ICU transfer

  10. Average time of discharge

    Time frame: up to 21 months

    time of discharge averaged

  11. Patient Activation Measure (PAM-13)

    Time frame: up to 21 months

    Patient Activation as measured by the PAM 13 survey

  12. 30-day non-elective readmission

    Time frame: up to 21 months

    30-day non-elective readmission

  13. Patient Satisfaction (HCAHPS)

    Time frame: up to 21 months

    Patient Satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Northeastern University

Registry information

Acronym: PSLL

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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