Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a cluster randomized trial across 10 hospitals, stratified by hospital size (hospitals with greater than 100 mechanically ventilated patients a year will be classified as large, while those with 100 or fewer will be classified as small). Randomization will occur at the hospital level, ensuring an even distribution of large and small hospitals between study arms. Hospitals assigned to the intervention group will implement an EHR-based strategy designed to enhance adherence to lung-protective ventilation (LPV) for a 9-month intervention period, after which the strategy will be rolled out to all hospitals. The intervention focuses on modifying the ventilator order within the Electronic Health Record (EHR) to encourage default settings aligned with LPV principles. This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Ventilator | Active Comparator | Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to the current ventilator order that is used across the health system. |
|
| Experimental Ventilator | Experimental | Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New ventilator | Device | The new ventilator order (intervention) was developed using economic behavior theory to decrease the cognitive burden on the ordering provider while enhancing the operability of the order itself. The strategy resulted in a new ventilator order that includes the following changes:
|
| Measure | Description | Time Frame |
|---|---|---|
| lung-protective ventilation | The primary outcome is a binary indicator of lung-protective ventilation (ventilator set at ≤ 8 cc/kg) at the first documented set tidal volume after 4 hours. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate (hours) with set tidal volume < 6cc/kg PBW | 72 hours | |
| Rate (hours) exposure to >8 cc/kg PBW | 72 hours | |
| Rate (hours) exposure to >10 cc/kg PBW |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nick Ingraham, MD, MS | Contact | (612) 624-0999 | ingra107@umn.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
Not provided
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.
The intervention will be tested within the MHFV health system which includes a 10-hospital network admitting over 2,500 mechanically ventilated patients annually.
Not provided
Not provided
Not provided
Not provided
|
| control ventilator | Device | Current ventilator order used by control hospitals |
|
| 72 hours |
| Time to adhere to ≤ 8 cc/kg per day: Of all patients set to >8 cc/kg per day, how long did it take for the patient to receive ≤ 8 cc/kg per day? | 72 hours |