NCT02969343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

October 24, 2016

Last Update Submit

July 8, 2019

Conditions

Central Line-Associated Bloodstream Infection (CLABSI)Venous ThromboembolismPatient FallCatheter-Associated InfectionSevere HypoglycemiaOpioid-Related Severe Adverse Drug EventHospital Acquired Pressure UlcerAdverse Drug EventSevere Hospital Acquired DeleriumRapid Response Related to Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (50)

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

    up to 21 months

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

    up to 21 months

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

    up to 21 months

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

    up to 21 months

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

    up to 21 months

  • +45 more secondary outcomes

Other Outcomes (13)

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

    up to 21 months

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

    up to 21 months

  • Usability of tools/ technology based on Health iTues survey

    up to 21 months

  • +10 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Patient Safety health information technologyBEHAVIORAL

Patient safety technology toolkits on hospital care units

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients 18-99 years of age

You may not qualify if:

  • patients under age 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 33201236DERIVED

MeSH Terms

Conditions

Venous ThromboembolismCatheter-Related InfectionsHypoglycemiaDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesInfectionsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesChemically-Induced Disorders

Study Officials

  • David W Bates, MD MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice President and Chief Innovation Officer

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 21, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)