Clinical trial NCT04744298: Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway
Official title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS With Protection, Paralysis, and Proning: TheraPPP Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2021-02-08
Enrollment: 19916
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study uses an effectiveness-implementation hybrid design (type 1). Phase 1 will evaluate effectiveness and Phase 2 will assess the implementation of the pathway. Implementation will occur via a pragmatic registry-based stepped wedge cluster randomization of ICUs. The unit of randomization will be a cluster of 2 ICUs. The intervention will be implemented into 1 cluster every 2 months. Once implemented, the cluster will continue to receive it for the remainder of the study.

Effectiveness: There will be a 10-month baseline data collection period at the beginning of the study. The total study duration will be 29 months (Estimated18816 mechanically ventilated patients including 2688 in the ARDS subgroup). The comparison (control) therapy will be usual management assessed in the baseline period.

Implementation: A process evaluation of pathway implementation will be conducted to 1) quantitatively evaluate fidelity, 2) qualitatively assess acceptability (Estimate 1100 clinicians).
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 and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.

The overall objective of TheraPPP Pathway is to improve the quality of care for patients with HRF. Implementation of the pathway across Alberta will test the effectiveness and implementation of the TheraPPP 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 TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The overall objective of the pathway is to improve the quality of care for patients with HRF. The specific objectives are to evaluate:

1. Effectiveness of the pathway. A cost-effectiveness analysis is a secondary objective.
2. Implementation of the pathway by conducting a process evaluation which will assess fidelity of the delivered interventions and clinician perceptions about the acceptability of the pathway.

Mechanically ventilated patients admitted to any one of 17 adult ICUs in Alberta will receive the intervention. One ICU (Calgary) is the setting for a pilot study (NCT04070053).

For data analysis, the investigators will use chart abstraction to quantitatively assess the fidelity of the delivered intervention, and surveys and focus groups to qualitatively assess clinician perceptions about the acceptability of the pathway. Fidelity of the intervention will be tracked using process of care indicators that reflect the five key steps of the pathway.

Eligibility criteria: Inclusion Criteria:

* Admitted to the one of the 17 adult Intensive Care Units in Alberta
* Invasively mechanically ventilated

Exclusion Criteria:

* none

Primary outcomes:
measure: EFFECTIVENESS (primary clinical outcome) 28-day ventilator free days
timeFrame: 4 months (after the study post-intervention period)
measure: IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score
timeFrame: 4 months (after the study post-intervention period)
measure: ECONOMIC (primary economic outcome) Cost per ventilator free day saved
timeFrame: 4 months (after the study post-intervention period)
Secondary outcomes:
measure: 28-day and hospital survival
timeFrame: 90 days
measure: Ventilator duration
timeFrame: 4 months (after the study post-intervention period)
measure: Driving Pressure
timeFrame: 4 months (after the study post-intervention period)
measure: Mechanical Power
timeFrame: 4 months (after the study post-intervention period)
measure: ICU and hospital length of stay
timeFrame: 4 months (after the study post-intervention period)
measure: Proportion of patients receiving rescue therapies specifically Extracorporeal Life Support (ECLS)
timeFrame: 4 months (after the study post-intervention period)
measure: The proportion of patients ventilated with a height measured
timeFrame: 4 months (after the study post-intervention period)
measure: Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg
timeFrame: 4 months (after the study post-intervention period)
measure: Proportion of patient days with PF ratio ≤300 with a plateau pressure measured
timeFrame: 4 months (after the study post-intervention period)
measure: Proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade
timeFrame: 4 months (after the study post-intervention period)
measure: Proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Composite Acceptability Score
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Opportunity costs construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Perceived effectiveness construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Affective attitude construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Burden construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Ethicality construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Self efficacy construct
timeFrame: 4 months (after the study post-intervention period)
measure: Theoretical Framework of Acceptability - Intervention coherence construct
timeFrame: 4 months (after the study post-intervention period)
measure: Total cost: ICU admission
timeFrame: 4 months (after the study post-intervention period)
measure: Total cost: Index hospitalization
timeFrame: 4 months (after the study post-intervention period)
measure: Cost per quality adjusted life year (QALY)
timeFrame: 4 months (after the study post-intervention period)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre (PLC)
state: Alberta
city: Calgary
country: Canada
facility: Foothills Hospital Intensive Care Unit
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Center Cardiovascular ICU
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital General Systems ICU
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital Neurosciences Intensive Care Unit
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Fort McMurray
country: Canada
facility: Northern Lights Regional Health Centre
state: Alberta
city: Grande Prairie
country: Canada
facility: Queen Elizabeth II Hospital
state: Alberta
city: Lethbridge
country: Canada
facility: Chinook Regional Hospital
state: Alberta
city: Medicine Hat
country: Canada
facility: Medicine Hat Regional Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital Centre
state: Alberta
city: St. Albert
country: Canada
facility: Sturgeon Community Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ken K Parhar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: