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Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway

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ClinicalTrials.gov Identifier: NCT04744298
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Ken Kuljit Parhar, MD, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Hypoxemic Respiratory Failure ARDS, Human Other: TheraPPP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3522 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

The study will use an effectiveness-implementation hybrid study 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 Intensive Care Units (ICUs). The unit of randomization will be a cluster of two ICUs. The intervention will be implemented into one cluster every two 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 27 months (Estimate: 2496 patients). The comparison (control) therapy will be usual management assessed in the baseline period.

Implementation: A process evaluation of TheraPPP pathway implementation will be conducted to 1) quantitatively evaluate fidelity, 2) qualitatively assess acceptability (Estimate 1048 clinicians).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS With Protection, Paralysis, and Proning: TheraPPP Study
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: TheraPPP Pathway

The investigators will perform an effectiveness-implementation hybrid study design (type 1) to evaluate the effectiveness and implementation of the TheraPPP pathway.

All mechanically ventilated patients admitted to the ICU will enter the pathway. To evaluate effectiveness the investigators will collect patient data for approximately 27 months. To assess acceptability of the pathway the investigators will conduct a survey and focus groups to clinicians who used the Pathway.

Other: TheraPPP

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.





Primary Outcome Measures :
  1. EFFECTIVENESS (primary clinical outcome) 28-day ventilator free days [ Time Frame: 4 months (after the study post-intervention period) ]
    A composite outcome of survival and days spent not ventilated over the first 28 days

  2. EFFECTIVENESS (primary economic outcome) Cost per ventilator free day saved [ Time Frame: 4 months (after the study post-intervention period) ]
    Cost per ventilator free day saved from the perspective of the health care system over the index hospitalization period

  3. IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score [ Time Frame: 4 months (after the study post-intervention period) ]

    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:

    1. If ventilated ≥24 hours, is a height measured (step 1)
    2. 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)
    3. If PF ratio ≤300, is a plateau pressure measured (step 3)
    4. IF patient has HRF and PF ratio ≤150, was neuromuscular blockade used in that 24 hour period (step 4)
    5. If the patient has HRF and PF ratio ≤150 and FiO2 ≥0.6, did the patient receive prone ventilation (step 5)

  4. IMPLEMENTATION (primary acceptability outcome) Theoretical Framework of Acceptability - Composite Acceptability Score [ Time Frame: 4 months (after the study post-intervention period) ]
    Pathway acceptability is measured using the Theoretical Framework of Acceptability (TFA). The primary outcome for acceptability is a composite score of the proportion of seven TFA constructs [(1) affective attitude (2) burden (3) ethicality (4) intervention coherence (5) opportunity costs (6) perceived effectiveness (7) self-efficacy] graded with a median score of 5 or above from a 7-point Likert scale, in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability).


Secondary Outcome Measures :
  1. Days of safe ventilation [ Time Frame: 4 months (after the study post-intervention period) ]
    Proportion of patient-days on controlled ventilation with median daily tidal volume less than or equal to 8mL/kg predicted body weight in patients who are eligible

  2. Proportion of days of safe ventilation in females [ Time Frame: 4 months (after the study post-intervention period) ]
    Days of safe ventilation for females (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)

  3. 28-day and hospital survival [ Time Frame: 90 days ]
    Number of patients who die in the ICU, hospital, and at or before 28-day hospital censored at 90 days

  4. Total cost: ICU admission [ Time Frame: 4 months (after the study post-intervention period) ]
    Total cost for the ICU admission

  5. Total cost: Index hospitalization [ Time Frame: 4 months (after the study post-intervention period) ]
    Total cost for the index hospitalization

  6. ICU and hospital length of stay [ Time Frame: 4 months (after the study post-intervention period) ]
    The number of days that patients stay in the ICU and in hospital

  7. Cost per quality adjusted life year (QALY) [ Time Frame: 4 months (after the study post-intervention period) ]
    Cost per quality adjusted life year (QALY) from the health care system perspective over the patient's lifetime

  8. The proportion of patients ventilated ≥24 hours with a height measured [ Time Frame: 4 months (after the study post-intervention period) ]
    Total number of ventilated patients for ≥24 hours with a height measured divided by the total number of patients ventilated ≥24 hours

  9. Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg stratified by volume and pressure control [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  10. Proportion of patient days with PF ratio ≤300 with a plateau pressure measured [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  11. Proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  12. Proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  13. Proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  14. The proportion of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation [ Time Frame: 4 months (after the study post-intervention period) ]
    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

  15. Proportion of patients receiving rescue therapies [ Time Frame: 4 months (after the study post-intervention period) ]
    The proportion of patients receiving rescue therapies including inhaled vasodilators, Extracorporeal Life Support

  16. Theoretical Framework of Acceptability - Opportunity costs construct [ Time Frame: 4 months (after the study post-intervention period) ]
    Benefits or costs to the participant for using the pathway graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  17. Theoretical Framework of Acceptability - Perceived effectiveness construct [ Time Frame: 4 months (after the study post-intervention period) ]
    The extent to which the intervention is perceived as likely to achieve its purpose graded graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  18. Theoretical Framework of Acceptability - Affective attitude construct [ Time Frame: 4 months (after the study post-intervention period) ]
    How an individual feels about the intervention graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  19. Theoretical Framework of Acceptability - Burden construct [ Time Frame: 4 months (after the study post-intervention period) ]
    The perceived amount of effort that is required to participate in the intervention graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  20. Theoretical Framework of Acceptability - Ethicality construct [ Time Frame: 4 months (after the study post-intervention period) ]
    The extent to which the intervention has a good fit with an individual's value graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  21. Theoretical Framework of Acceptability - Self efficacy construct [ Time Frame: 4 months (after the study post-intervention period) ]
    The participant's confidence that they can perform the behavior(s) required to participate in the intervention graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)

  22. Theoretical Framework of Acceptability - Intervention coherence construct [ Time Frame: 4 months (after the study post-intervention period) ]
    The extent to which the participant understands the invention and how it works graded on a 7-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 7 indicates strong agreement (and higher acceptability), Median (IQR)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744298


Contacts
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Contact: Ken K Parhar, MD, MSc 403-944-2471 ken.parhar@albertahealthservices.ca

Locations
Show Show 17 study locations
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
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Principal Investigator: Ken K Parhar, MD, MSc University of Calgary
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Responsible Party: Ken Kuljit Parhar, MD, Consultant Intensivist & Clinical Assistant Professor Affiliation: University of Calgary, University of Calgary
ClinicalTrials.gov Identifier: NCT04744298    
Other Study ID Numbers: REB20-0646
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury
Paralysis
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Neurologic Manifestations
Nervous System Diseases