Provider Perceptions of Neuromuscular Blockade in ARDS

The proposed study will use qualitative methodology to understand health care provider perceptions of neuromuscular blockade (NMB) in patients with Acute Respiratory Distress Syndrome (ARDS). To achieve this goal the investigators will conduct a prospective ancillary study at four clinical centers participating in the NHLBI PETAL network as part of the ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) clinical trial (NCT02509078). Using thematic content analysis of semistructured interviews with health care providers caring for patients enrolled in the ROSE trial the investigators will determine the barriers to NMB use and develop a framework for future NMB adoption in ARDS.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Neuromuscular Blockade
• Intervention / Treatment: Behavioral: Interview

Detailed Description

Efficient translation of clinical trial results into practice is an enduring challenge in critical care, with many critically ill patients not receiving evidence-based therapies proven to save lives. One approach to speed the translation of clinical trial evidence into practice is through qualitative research to better understand the barriers to evidence-based care and help design innovative interventions to overcome those barriers.. This work need not wait until the clinical trial is complete-an emerging literature highlights the value of qualitative research concurrent with the conduct of a clinical trial. Such research has several potential benefits, including facilitating implementation of the intervention in the real world, identifying the potential mechanism of action, and identifying contextual factors necessary for the treatments effectiveness.

The Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE) study, conducted by the NHLBI PETAL Clinical Trials Network, is an ideal trial for which to perform a concurrent qualitative implementation study (NCT02509078). NMB has the potential to substantially reduce mortality in ARDS. Yet NMB remains incompletely adopted for reasons that are poorly understood but likely relate to clinical equipoise, historical concerns about safety, and the inherent difficulties in providing complex practices in the intensive care unit (ICU). A better understanding of provider views regarding NMB will provide essential data to aid interpretation of study results and design an implementation study should ROSE demonstrate a survival benefit with NMB.

To examine this issue the investigators will perform a prospective qualitative study using semi-structured interviews health care professionals providing direct care for patients enrolled in ROSE. A trained research coordinator will perform semi-structured interviews with consenting participants. Interviews will be transcribed and uploaded into commercially available qualitative data software. Trained qualitative researchers will read and code each interview based on Consolidated Framework for Implementation Research, a widely accepted conceptual theory of evidence-uptake.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittburgh Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Health care professionals with direct experience in either caring for patients enrolled in the ROSE trial (NCT02509078) or caring for patients with ARDS eligible for ROSe but not enrolled.

Description

Inclusion Criteria:

• physician, nurse, respiratory therapist or clinical pharmacist providing direct care for patients enrolled in the ROSE study; or physician who refused entry of their patient into the ROSE study

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; The investigators will interview physicians, nurses, respiratory therapists and other clinicians who have cared for patients enrolled in the active treatment arm of ROSE.	Behavioral: Interview; The investigators will perform and analyze semi-structured interviews with enrolled participants.
Control; The investigators will interview physicians, nurses, respiratory therapists and other clinicians who have cared for patients enrolled in the control treatment arm of ROSE.	Behavioral: Interview; The investigators will perform and analyze semi-structured interviews with enrolled participants.
Refusal; The investigators will interview physicians who have refused to allow their patients to be enrolled in ROSE.	Behavioral: Interview; The investigators will perform and analyze semi-structured interviews with enrolled participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to adoption of NMB	As a qualitative study, this study has no quantitative outcome measures. Provider perceptions of the knowledge, attitude, and behavioral barriers to adoption of early NMB in ARDS will be assessed using a semi-structured interview guide.	1 month post enrollment
Contextual factors that influence the effectiveness of NMB	As a qualitative study, this study has no quantitative outcome measures. Provider perceptions of the clinical and organizational factors that influence the impact of NMB on patient centered outcomes will be assessed using a semi-structured interview guide.	1 month post enrollment

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jeremy M Kahn, MD, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 18, 2018
• Study Completion (Actual): March 18, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; Implementation Science; Neuromuscular Blockade; Interviews
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 170115; U01HL123020 (U.S. NIH Grant/Contract)

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