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

NCT ID: NCT02969343

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient Safety health information technology

Intervention Type: BEHAVIORAL

Patient safety technology toolkits on hospital care units

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient Safety health information technology

Patient safety technology toolkits on hospital care units

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients 18-99 years of age

Exclusion Criteria

• patients under age 18 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David W. Bates, MD, MSc

Senior Vice President and Chief Innovation Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David W Bates, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33201236 (View on PubMed)

Other Identifiers

5P30HS023535

Identifier Type: AHRQ

Identifier Source: org_study_id

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