Trial Outcomes & Findings for Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study (NCT NCT04663802)
NCT ID: NCT04663802
Last Updated: 2024-10-08
Results Overview
percentage of time that a patient is exposed to tidal volume \<6.5 cc/kg ideal body weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7342 participants
Primary outcome timeframe
up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation
Results posted on
2024-10-08
Participant Flow
Unit of analysis: Intensive care units (ICUs)
Participant milestones
| Measure |
Strategy A+C, Wedge 1 (ICU #1)
3 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 milliliters per kilogram predicted body weight \[cc/kg PBW\]that can be opted out of by the ordering clinician at any time with a click), followed by 18 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 1 (ICU #2)
3 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 18 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy A+C, Wedge 2 (ICU #3)
6 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 15 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 2 (ICU #4)
6 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 15 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg PBW into the flowsheet).
|
Strategy A+C, Wedge 3 (ICU #5)
9 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 12 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 3 (ICU #6)
9 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 12 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy A+C, Wedge 4 (ICU #7)
12 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 9 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 4 (ICU #8)
12 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 9 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy A+C, Wedge 5 (ICU #9)
15 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 6 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 5 (ICU #10)
15 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 6 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy A+C, Wedge 6 (ICU #11)
18 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 3 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
|
Strategy B+C, Wedge 6 (ICU #12)
18 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 3 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet).
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Step 1: 2/22/2021 to 5/16/2021
STARTED
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85 1
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91 1
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30 1
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28 1
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53 1
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104 1
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66 1
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141 1
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55 1
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58 1
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40 1
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Step 1: 2/22/2021 to 5/16/2021
COMPLETED
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85 1
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91 1
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30 1
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28 1
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73 1
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53 1
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104 1
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66 1
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141 1
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55 1
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58 1
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40 1
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Step 1: 2/22/2021 to 5/16/2021
NOT COMPLETED
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Step 2: 5/17/2021 to 8/15/2021
STARTED
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64 1
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39 1
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64 1
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40 1
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95 1
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61 1
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132 1
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46 1
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62 1
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Step 2: 5/17/2021 to 8/15/2021
COMPLETED
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64 1
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99 1
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39 1
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24 1
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40 1
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95 1
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61 1
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132 1
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46 1
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62 1
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40 1
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Step 2: 5/17/2021 to 8/15/2021
NOT COMPLETED
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0 0
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Step 3: 8/16/2021 to 11/14/2021
STARTED
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88 1
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76 1
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38 1
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21 1
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67 1
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38 1
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91 1
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66 1
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124 1
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52 1
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73 1
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53 1
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Step 3: 8/16/2021 to 11/14/2021
COMPLETED
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88 1
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76 1
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38 1
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21 1
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67 1
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38 1
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91 1
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66 1
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124 1
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52 1
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73 1
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53 1
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Step 3: 8/16/2021 to 11/14/2021
NOT COMPLETED
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0 0
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Step 4: 11/15/2021 to 2/20/2022
STARTED
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76 1
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86 1
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56 1
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49 1
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71 1
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47 1
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97 1
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68 1
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151 1
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69 1
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83 1
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82 1
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Step 4: 11/15/2021 to 2/20/2022
COMPLETED
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76 1
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86 1
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56 1
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49 1
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71 1
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47 1
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97 1
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68 1
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151 1
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69 1
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83 1
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82 1
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Step 4: 11/15/2021 to 2/20/2022
NOT COMPLETED
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0 0
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Step 5: 2/21/2022 to 5/15/2022
STARTED
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71 1
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71 1
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41 1
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32 1
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73 1
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27 1
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73 1
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58 1
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132 1
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48 1
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Step 5: 2/21/2022 to 5/15/2022
COMPLETED
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71 1
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71 1
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41 1
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32 1
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73 1
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27 1
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73 1
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58 1
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132 1
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48 1
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70 1
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51 1
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Step 5: 2/21/2022 to 5/15/2022
NOT COMPLETED
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0 0
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Step 6: 5/16/2022 to 8/21/2022
STARTED
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66 1
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74 1
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39 1
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38 1
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36 1
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76 1
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67 1
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128 1
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67 1
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63 1
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Step 6: 5/16/2022 to 8/21/2022
COMPLETED
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66 1
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74 1
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39 1
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71 1
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36 1
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76 1
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67 1
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128 1
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67 1
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63 1
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59 1
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Step 6: 5/16/2022 to 8/21/2022
NOT COMPLETED
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Step 7: 8/22/2022 to11/20/2022
STARTED
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78 1
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75 1
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51 1
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73 1
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37 1
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78 1
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159 1
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70 1
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Step 7: 8/22/2022 to11/20/2022
COMPLETED
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78 1
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75 1
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51 1
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48 1
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73 1
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37 1
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86 1
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78 1
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159 1
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70 1
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77 1
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64 1
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Step 7: 8/22/2022 to11/20/2022
NOT COMPLETED
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Step 8: 11/21/2022 to 2/19/2023
STARTED
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71 1
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88 1
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41 1
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46 1
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80 1
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48 1
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103 1
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67 1
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117 1
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80 1
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55 1
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Step 8: 11/21/2022 to 2/19/2023
COMPLETED
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71 1
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88 1
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41 1
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46 1
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80 1
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48 1
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103 1
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67 1
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117 1
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80 1
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55 1
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86 1
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Step 8: 11/21/2022 to 2/19/2023
NOT COMPLETED
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0 0
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Step 9: 2/20/2023 to 5/15/2023
STARTED
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72 1
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65 1
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35 1
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38 1
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73 1
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43 1
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85 1
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56 1
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103 1
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55 1
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53 1
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43 1
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Step 9: 2/20/2023 to 5/15/2023
COMPLETED
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72 1
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65 1
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35 1
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38 1
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73 1
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43 1
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85 1
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56 1
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103 1
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55 1
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53 1
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43 1
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Step 9: 2/20/2023 to 5/15/2023
NOT COMPLETED
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Baseline characteristics by cohort
| Measure |
Standard of Care (Baseline)
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
Physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have both the physician-targeted and respiratory therapist-targeted accountable justification interventions
Physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Total
n=7342 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
61 years
n=7 Participants
|
64 years
n=5 Participants
|
63 years
n=4 Participants
|
63 years
n=21 Participants
|
63 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1199 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
569 Participants
n=4 Participants
|
512 Participants
n=21 Participants
|
2941 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1777 Participants
n=5 Participants
|
620 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
911 Participants
n=4 Participants
|
684 Participants
n=21 Participants
|
4401 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2853 Participants
n=5 Participants
|
915 Participants
n=7 Participants
|
710 Participants
n=5 Participants
|
1452 Participants
n=4 Participants
|
1186 Participants
n=21 Participants
|
7116 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
98 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
169 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
268 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1063 Participants
n=5 Participants
|
328 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
521 Participants
n=4 Participants
|
407 Participants
n=21 Participants
|
2569 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1496 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
671 Participants
n=4 Participants
|
607 Participants
n=21 Participants
|
3610 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
304 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
843 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2976 participants
n=5 Participants
|
956 participants
n=7 Participants
|
734 participants
n=5 Participants
|
1480 participants
n=4 Participants
|
1196 participants
n=21 Participants
|
7342 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilationpercentage of time that a patient is exposed to tidal volume \<6.5 cc/kg ideal body weight
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Fidelity to LPV
|
43.3 Percentage of time during first 72 hours
Interval 0.0 to 100.0
|
19.1 Percentage of time during first 72 hours
Interval 0.0 to 98.3
|
83.9 Percentage of time during first 72 hours
Interval 0.5 to 100.0
|
31.0 Percentage of time during first 72 hours
Interval 0.0 to 99.5
|
67.8 Percentage of time during first 72 hours
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)Total duration of exposure to tidal volume greater than 8 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Total Duration of Exposure to Tidal Volume >8 cc/kg PBW
|
0.08 hours
Interval 0.0 to 10.47
|
0.51 hours
Interval 0.0 to 10.81
|
0 hours
Interval 0.0 to 6.45
|
0.37 hours
Interval 0.0 to 11.06
|
0.09 hours
Interval 0.0 to 7.98
|
SECONDARY outcome
Timeframe: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)Total duration of exposure to tidal volume greater than 10 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Total Duration of Exposure to Tidal Volume >10 cc/kg PBW
|
0 hours
Interval 0.0 to 1.0
|
0 hours
Interval 0.0 to 1.54
|
0 hours
Interval 0.0 to 0.25
|
0 hours
Interval 0.0 to 1.32
|
0 hours
Interval 0.0 to 1.06
|
SECONDARY outcome
Timeframe: within 24 hours of initiation of mechanical ventilation in a study ICUBinary variable for whether initial tidal volume (first documented value after initiation of mechanical ventilation in a study ICU) is less than or equal to 6.5 milliliters per kilogram of predicted body weight (cc/kg PBW)
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Initial Tidal Volume Administered
> 6.5 cc/kg PBW
|
1628 Participants
|
539 Participants
|
347 Participants
|
822 Participants
|
562 Participants
|
|
Initial Tidal Volume Administered
< or equal to 6.5 cc/kg PBW
|
1348 Participants
|
417 Participants
|
387 Participants
|
658 Participants
|
634 Participants
|
SECONDARY outcome
Timeframe: within 24 hours of initiation of mechanical ventilation in a study ICUBinary variable for whether initial plateau pressure (Pplat) \> 30 cm H2O (first documented value after initiation of mechanical ventilation in a study ICU)
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
>30
|
126 Participants
|
26 Participants
|
37 Participants
|
34 Participants
|
43 Participants
|
|
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
< 30
|
2310 Participants
|
806 Participants
|
507 Participants
|
1187 Participants
|
903 Participants
|
|
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
missing
|
540 Participants
|
124 Participants
|
190 Participants
|
259 Participants
|
250 Participants
|
SECONDARY outcome
Timeframe: All-cause mortality as a study outcome was assessed through hospital discharge, up to 720 hours (30 days); all adverse events (including mortality) were assessed though 24 hours after initiation of mechanical ventilation.All-cause mortality occurring during hospitalization.
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Hospital Mortality
|
977 Participants
|
294 Participants
|
268 Participants
|
417 Participants
|
437 Participants
|
SECONDARY outcome
Timeframe: from time of first eligibility to 30 daysdays alive and not admitted to an ICU; composite of ICU length of stay and death
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
ICU-free Days
|
18 days
Interval 0.0 to 26.0
|
16 days
Interval 0.0 to 25.0
|
18.5 days
Interval 0.0 to 26.0
|
19 days
Interval 0.0 to 26.0
|
18 days
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: from time of first eligibility to 30 daysdays alive and not admitted to a hospital;composite of hospital length of stay and death
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Hospital Free Days
|
2 days
Interval 0.0 to 19.0
|
0 days
Interval 0.0 to 17.0
|
0.5 days
Interval 0.0 to 20.0
|
2 days
Interval 0.0 to 19.0
|
0 days
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: from time of first eligiblity to 30 daysdays alive and not on mechanical ventilation; composite of ventilator free days and death
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Ventilator Free Days
|
22 days
Interval 0.0 to 29.0
|
23 days
Interval 0.0 to 29.0
|
21 days
Interval 0.0 to 28.0
|
25 days
Interval 1.0 to 29.0
|
21.5 days
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICULocation to which the patient was discharged after the end of the hospital admission
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Hospital Discharge Disposition
ACH
|
188 Participants
|
63 Participants
|
63 Participants
|
108 Participants
|
100 Participants
|
|
Hospital Discharge Disposition
REHAB
|
459 Participants
|
177 Participants
|
52 Participants
|
270 Participants
|
123 Participants
|
|
Hospital Discharge Disposition
SNF
|
372 Participants
|
104 Participants
|
114 Participants
|
192 Participants
|
170 Participants
|
|
Hospital Discharge Disposition
EXPIRED
|
844 Participants
|
264 Participants
|
231 Participants
|
367 Participants
|
394 Participants
|
|
Hospital Discharge Disposition
HOME
|
954 Participants
|
310 Participants
|
228 Participants
|
488 Participants
|
354 Participants
|
|
Hospital Discharge Disposition
HOSPICE
|
133 Participants
|
30 Participants
|
37 Participants
|
50 Participants
|
43 Participants
|
|
Hospital Discharge Disposition
OTHER
|
26 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICUThe percentage of time during the first 72 hours of mechanical ventilation that patients were alive, in the ICU, and with Richmond Agitation-Sedation Scale (RASS) of -3 to -5 . The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Outcome measures
| Measure |
Standard of Care
n=2953 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=949 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=725 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1473 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1189 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Early Deep Sedation
|
33 percentage of time
Interval 3.0 to 93.0
|
33 percentage of time
Interval 15.0 to 100.0
|
33 percentage of time
Interval 0.0 to 83.0
|
33 percentage of time
Interval 16.0 to 100.0
|
33 percentage of time
Interval 0.0 to 91.0
|
SECONDARY outcome
Timeframe: Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICUAverage Richmond Agitation-Sedation Scale (RASS) value, weighted by duration of time at that value. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Outcome measures
| Measure |
Standard of Care
n=2953 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=949 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=725 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1473 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1189 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Average Sedation Intensity Within the First 72 Hours
|
-2.09 score on a scale
Interval -3.44 to -1.88
|
-2.56 score on a scale
Interval -3.89 to -1.62
|
-1.8 score on a scale
Interval -3.02 to -0.92
|
-2.59 score on a scale
Interval -3.81 to -1.47
|
-1.99 score on a scale
Interval -3.24 to -1.09
|
SECONDARY outcome
Timeframe: up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICUBinary variable for whether a patient had Richmond Agitation-Sedation Scale (RASS) score of -3 to -5 for the entirety of the first 72 hours of mechanical ventilation. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Outcome measures
| Measure |
Standard of Care
n=2976 Participants
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 Participants
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 Participants
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 Participants
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 Participants
This arm will have the default order set and respiratory therapist-targeted accountable justification
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
|---|---|---|---|---|---|
|
Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation
Yes
|
594 Participants
|
264 Participants
|
119 Participants
|
392 Participants
|
229 Participants
|
|
Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation
Missing
|
20 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation
No
|
2362 Participants
|
687 Participants
|
609 Participants
|
1083 Participants
|
962 Participants
|
Adverse Events
Standard of Care
Serious events: 95 serious events
Other events: 0 other events
Deaths: 844 deaths
Default Order Set
Serious events: 24 serious events
Other events: 0 other events
Deaths: 264 deaths
Physician-targeted Accountable Justification
Serious events: 39 serious events
Other events: 0 other events
Deaths: 231 deaths
Default Order Set + RT-targeted Accountable Justification
Serious events: 42 serious events
Other events: 0 other events
Deaths: 367 deaths
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
Serious events: 64 serious events
Other events: 0 other events
Deaths: 394 deaths
Serious adverse events
| Measure |
Standard of Care
n=2976 participants at risk
This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention
|
Default Order Set
n=956 participants at risk
This arm will have the default order set implementation strategy
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
|
Physician-targeted Accountable Justification
n=734 participants at risk
This arm will have the physician-targeted accountable justification implementation strategy
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
|
Default Order Set + RT-targeted Accountable Justification
n=1480 participants at risk
This arm will have the default order set and physician-targeted accountable justification
Default order set: With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
Physician-targeted Accountable Justification + RT-targeted Accountable Justification
n=1196 participants at risk
This arm will have the physician-targeted accountable justification order set and respiratory therapist-targeted accountable justification flowsheet
physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
life-threatening acidemia
|
0.94%
28/2976 • Number of events 28 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
1.4%
13/956 • Number of events 13 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
2.5%
18/734 • Number of events 18 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
1.3%
19/1480 • Number of events 19 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
2.3%
27/1196 • Number of events 27 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
|
Respiratory, thoracic and mediastinal disorders
mortality within 24 hours
|
1.7%
50/2976 • Number of events 50 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
0.94%
9/956 • Number of events 9 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
2.6%
19/734 • Number of events 19 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
1.2%
18/1480 • Number of events 18 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
2.4%
29/1196 • Number of events 29 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
|
Cardiac disorders
cardiac arrest within 24 hours
|
0.57%
17/2976 • Number of events 17 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
0.21%
2/956 • Number of events 2 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
0.27%
2/734 • Number of events 2 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
0.34%
5/1480 • Number of events 5 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
0.67%
8/1196 • Number of events 8 • All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH \<7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meeta Prasad Kerlin (PI)
University of Pennsylvania
Phone: 215-746-0446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place