A Cluster Randomized Controlled Trial of a Multi-component Strategy to Improve Implementation of Low Tidal Volume Ventilation for Patients With Acute Respiratory Distress Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwestern University
- Locations
- 2
- Primary Endpoint
- LTVV rate
Study Overview
Brief Summary
The primary objective of this study is to evaluate whether a multi-component implementation strategy/quality improvement intervention comprised of 1) clinical decision support that couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS) recognition tool with a clinician alert system, and 2) audit and feedback improves the implementation of low tidal volume ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS). This will be accomplished with a cluster randomized controlled trial comparing the implementation strategy to usual care
Detailed Description
Setting:
This is a multi-ICU, single-center cluster randomized trial that will be conducted among the patients and their clinicians on four adult ICU services at Northwestern Memorial Hospital. Each ICU service will act as a cluster.
Each ICU service cares for patients in one or two physical ICU locations:
- MICU service (Medical ICU location)
- NCC service (Neuroscience/spine ICU location)
- ACC service (Cardiothoracic/transplant ICU and neuroscience/spine ICU locations)
- SCC service (Cardiothoracic/transplant ICU and surgical ICU locations)
Overall Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All critical care attending physicians and critical care fellows who provide patient care on one of the participating ICU physician services at Northwestern Memorial Hospital (medical ICU [MICU], surgical critical care [SCC], anesthesia/critical care [ACC], neurocritical care [NCC]) during the study period
- •All resident physicians who provide patient care on the participating ICU services during the study period
- •All nurses who provide patient care in the participating ICUs during the study period
- •All respiratory therapists (RTs) who provide patient care in the participating ICUs during the study period
- •Patient Inclusion Criteria:
- •All patients admitted to a participating ICU service listed above during the study period and meeting the following additional criteria:
- •Age 18 or older
- •Receiving mechanical ventilation via endotracheal tube or tracheostomy
- •For primary analysis: meeting Berlin Definition of ARDS (as adjudicated by NLP algorithm)(2)
- •For non-ARDS comparator group: all patients meeting other inclusion criteria and not adjudicated as having ARDS
- •For pre-trial period: all patients age 18 or older and receiving mechanical ventilation
Exclusion Criteria
- •Patients whose time from ARDS onset to the earlier of extubation, death, or ICU discharge is less than 24 hours. ARDS onset is defined as the time at which the latter of the following two events occurred: PaO2/FIO2 <= 300 and bilateral infiltrates reported on a chest imaging radiology report (these must be within 24 hours of each other).
Outcomes
Primary Outcomes
LTVV rate
Time Frame: 12 months
The primary endpoint is the difference between intervention ICUs (ICUs A and B) and usual care ICUs (ICUs C and D) in the change in the LTVV rate between the pre-trial period and the trial period. The statistical analysis of the primary endpoint will be to test the null hypothesis that there is no difference in the change in the LTVV rate between intervention and usual care groups. LTVV is defined as a patient who receives any single tidal volume less than 6.5mL/kg predicted body weight between ARDS onset and the earlier or extubation, death, or ICU discharge. ARDS onset is defined as the time at which the latter of the following two events occurred: PaO2/FIO2 \<= 300 and bilateral infiltrates reported on a chest imaging radiology report, which themselves must occur within 24 hours of each other.
Secondary Outcomes
- Difference in proportions of patients receiving LTVV between intervention and usual care groups during pre-trial period(12 months)
- LTVV rate in individual ICUs(12 Months)
- Difference in overall LTVV rate between pre-trial and trial periods(12 Months)
- Percentage of time receiving LTVV(12 Months)
- Proportion of clinicians using LTVV(12 Months)
- Intervention delivered as intended(12 Months)
- Subgroup analyses of primary and secondary endpoints based on FiO2(12 months)
- Subgroup analyses of primary and secondary endpoints based on plateau pressure(12 months)
- Difference in proportions of patients receiving LTVV between intervention and usual care groups during trial period(12 Months)
- Percentage of ventilator settings adherent to LTVV(12 Months)
- ARDS duration(12 Months)
- Plateau pressure(12 Months)
- ICU and hospital length of stay(12 Months)
- ICU, hospital, 30-, 60-, 90-, 180-day and one year mortality(12 Months)
- Time from ARDS onset to LTVV initiation(12 Months)
- Discharge status(12 Months)
- Ventilator duration(12 Months)
- Subgroup analyses of primary and secondary endpoints based on ARDS severity(12 Months)
Investigators
Curtis Weiss
Principal Investigator
Northwestern University