Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway (TheraPPP)

Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway: a Pilot Before and After Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; ARDS, Human; Hypoxemic Respiratory Failure
• Intervention / Treatment: Other: 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 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.

• Study Type: Interventional
• Enrollment (Actual): 920
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Hospital Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TheraPPP Pathway; 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 and one year post-implementation periods. To assess Pathway feasibility we will collect patient data for approximately two years and one month: one year immediately prior to implementation, one month during, and one year following implementation. To assess acceptability of the pathway we will conduct a survey to clinicians who used the Pathway.

Other: TheraPPP Pathway; TheraPPP Steps: Step 1. All mechanically ventilated patients will have a height measured and documented. Step 2. Screening for HRF. Step 3. Initiate Lung Protective Ventilation (LPV). Step 4. Paralysis. Step 5. Prone Positioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEASIBILITY (Fidelity) Fidelity of the intervention using a composite fidelity score	The composite fidelity score is measured daily for each patient. It is scored out of 5 and awards 1 point for each fidelity indicator (listed below) that investigators are able to measure,; If ventilated ≥24 hours, is a height measured (step 1); If arterial to inspired oxygen ratio (PaO2:FiO2 ratio or PF ratio) ≤300, is the medial tidal volume ≤8mL/kg stratified by volume and pressure control (step2/3); If PF ratio ≤300, is a plateau pressure measured (step 3); IF patient has HRF and PF ratio ≤150, was neuromuscular blockade used in that 24 hour period (step 4); If the patient has HRF and PF ratio ≤150 and FiO2 ≥0.6, did the patient receive prone ventilation (step 5).	4 months (after the post-implementation period)
FEASIBILITY (Economic) Cost per safe ventilation day	Cost per safe ventilation day from the perspective of the health care system	4 months (after the post-implementation period)
ACCEPTABILITY Pathway Acceptability measured using the Theoretical Framework of Acceptability (TFA)	The primary outcome for acceptability is the proportion of seven TFA constructs (7 constructs of acceptability) graded with a median score of 5 or above from a 7-point Likert scale, indicating agreement.	4 months (after the post-implementation period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of ventilated patients with a height measured	Total number of ventilated patients with a height measured divided by the total number of ventilated patients	4 months (after the post-implementation period)
The proportion of ventilated patients with a height measured within 1 hour of admission	Total number of ventilated patients with a height measured within 1 hour of admission divided by the total number of ventilated patients	4 months (after the post-implementation period)
The proportion of patients ventilated ≥24 hours with a height measured	Total number of ventilated patients for ≥24 hours with a height measured divided by the total number of ventilated patients ≥24 hours	4 months (after the post-implementation period)
The median time to height measurement from admission	The median time to height measurement from admission for patients ventilated ≥24 hours	4 months (after the post-implementation period)
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	The total number of patient days with arterial to inspired oxygen ratio(PaO2:FiO2 ratio or PF ratio) ≤300 with a tidal volume ≤8 mL/kg divided by the total number of of patient days with arterial to inspired oxygen ratio(PaO2:FiO2 ratio or PF ratio) ≤300 stratified by volume and pressure control	4 months (after the post-implementation period)
The proportion of patient days with PF ratio ≤300 with a plateau pressure measured	The total number of patient days with PF ratio ≤300 with a plateau pressure measured divided by the total number of patient days with PF ratio ≤300	4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade	The number of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade divided by the number of patient days with HRF and PF ratio ≤150	4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade	The number of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade divided by the number of patient days with HRF and PF ratio ≤100	4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation	The number of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation divided by the number of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6	4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation	The number of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation divided by the number of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6	4 months (after the post-implementation period)
Days of safe ventilation for females	Days of safe ventilation for females (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)	4 months (after the post-implementation period)
Number of patients who do not survive	Number of patients who die in the ICU, hospital, and at or before 28-day hospital	4 months (after the post-implementation period)
Number of ventilator-free days (VFDs) 28-day ventilator-free days (VFDs)	Number of days that patients are not on the ventilator	4 months (after the post-implementation period)
The proportion of patients receiving rescue therapies	The proportion of patients receiving rescue therapies including inhaled vasodilators, Extracorporeal Life Support.	4 months (after the post-implementation period)
Total cost for the ICU admission	Total cost for the ICU admission	4 months (after the post-implementation period)
Total cost for the index hospitalization	Total cost for the index hospitalization	4 months (after the post-implementation period)
Length of Stay (LOS) (ICU, hospital) / the number of days that patients stay in the ICU and in hospital	The number of days that patients stay in the ICU and in hospital	4 months (after the post-implementation period)
Days of safe ventilation	Days of safe ventilation (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)	4 months (after the post-implementation period)

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Ken Parhar, MD MSc, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Neurologic Manifestations; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Paralysis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: REB19-0939; 2019 (Chief Medical Office (CMO) Alberta Health Services); 897 (Other Grant/Funding Number: M.S.I. Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No