Clinical trial NCT04070053: Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway
Official title: Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway: a Pilot Before and After Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Hypoxemic Respiratory Failure
ARDS, Human
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2019-08-28
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will perform a before and after study to evaluate the feasibility and acceptability of the HRF and ARDS Pathway during its pilot implementation. All mechanically ventilated patients will enter the pathway during the one month implementation period and one year post-implementation period.

To assess Pathway feasibility we will collect patient data for two years and one month: one year immediately prior to implementation as well as one month during plus one year following implementation.

To assess acceptability of the pathway we will conduct a survey to clinicians who used the pathway.
Primary purpose: TREATMENT

Brief summary: Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.

The purpose of this pilot study is to test the feasibility and acceptability of the TheraPPP Pathway. To assess feasibility, the investigators will test the ability to measure adherence to the pathway as well as patient and economic outcomes. To assess perceptions about the acceptability of the TheraPPP Pathway, the investigators will conduct a survey to clinicians who used the Pathway.

Detailed description: Hypoxemic respiratory failure (HRF) and ARDS are common conditions among patients admitted to the Intensive care unit (ICU). Treatment of these patients is complex. Evidence based therapies that can improve survival exist; however, implementation is extremely inconsistent. As a potential solution to this problem, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway to reduce practice variation and improve adherence to evidence-informed therapy. The objective of this pilot before and after study is to evaluate the feasibility and acceptability of the TheraPPP Pathway.

The pilot study will use a before and after quasi-experimental design to evaluate the feasibility and acceptability of the TheraPPP pathway. The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The study will be conducted in a single center mixed medical surgical ICU. The study population will include all patients who are admitted to the ICU and are mechanically ventilated.

The pathway will be implemented over a one month period, followed by a one year post implementation assessment period. The comparison (control) therapy will be usual management assessed in the one year pre-implementation period. We estimate approximately 1000 patients will be included in the study.

The primary objectives of the pilot study will be to assess feasibility and acceptability. To assess feasibility, the investigators will test the ability to measure: (1) Fidelity through 5 process of care indicators (2) Patient and economic outcomes. To assess the acceptability of the Pathway, the investigators will conduct a survey to clinicians who used the pathway. The acceptability survey will be sent to approximately 250 ICU clinicians.

For data analysis, no specific comparisons will be made as the investigators are testing the ability to measure the outcomes. However, feasibility and acceptability data will be presented in aggregate as frequency with proportion or median with interquartile range, as appropriate.

Eligibility criteria: Inclusion Criteria:

* Foothills Medical Center Intensive Care Unit (Pod A)
* Invasively mechanically ventilated

Exclusion Criteria:

* none

Primary outcomes:
measure: FEASIBILITY (Fidelity) Fidelity of the intervention using a composite fidelity score
timeFrame: 4 months (after the post-implementation period)
measure: FEASIBILITY (Economic) Cost per safe ventilation day
timeFrame: 4 months (after the post-implementation period)
measure: ACCEPTABILITY Pathway Acceptability measured using the Theoretical Framework of Acceptability (TFA)
timeFrame: 4 months (after the post-implementation period)
Secondary outcomes:
measure: The proportion of ventilated patients with a height measured
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of ventilated patients with a height measured within 1 hour of admission
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patients ventilated ≥24 hours with a height measured
timeFrame: 4 months (after the post-implementation period)
measure: The median time to height measurement from admission
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with arterial to inspired oxygen ratio(PaO2:FiO2 ratio or PF ratio) ≤300 with a tidal volume ≤8mL/kg stratified by volume and pressure control
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with PF ratio ≤300 with a plateau pressure measured
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation
timeFrame: 4 months (after the post-implementation period)
measure: Days of safe ventilation for females
timeFrame: 4 months (after the post-implementation period)
measure: Number of patients who do not survive
timeFrame: 4 months (after the post-implementation period)
measure: Number of ventilator-free days (VFDs) 28-day ventilator-free days (VFDs)
timeFrame: 4 months (after the post-implementation period)
measure: The proportion of patients receiving rescue therapies
timeFrame: 4 months (after the post-implementation period)
measure: Total cost for the ICU admission
timeFrame: 4 months (after the post-implementation period)
measure: Total cost for the index hospitalization
timeFrame: 4 months (after the post-implementation period)
measure: Length of Stay (LOS) (ICU, hospital) / the number of days that patients stay in the ICU and in hospital
timeFrame: 4 months (after the post-implementation period)
measure: Days of safe ventilation
timeFrame: 4 months (after the post-implementation period)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital Intensive Care Unit
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ken Parhar, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: