Provider Perceptions of Neuromuscular Blockade in ARDS

NCT ID: NCT03179709

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-03-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuromuscular Blockade Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Interview

Intervention Type BEHAVIORAL

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.

Interview

Intervention Type BEHAVIORAL

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.

Interview

Intervention Type BEHAVIORAL

The investigators will perform and analyze semi-structured interviews with enrolled participants.

Interventions

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Interview

The investigators will perform and analyze semi-structured interviews with enrolled participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Kahn

Professor of Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy M Kahn, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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U01HL123020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

170115

Identifier Type: -

Identifier Source: org_study_id

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