NCT03179709

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2018

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

May 31, 2017

Last Update Submit

January 6, 2020

Conditions

Keywords

Acute Respiratory Distress SyndromeNeuromuscular BlockadeInterviewsImplementation Science

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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

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

Refusal

The investigators will interview physicians who have refused to allow their patients to be enrolled in ROSE.

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

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

ControlInterventionRefusal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jeremy M Kahn, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Critical Care Medicine

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 7, 2017

Study Start

July 1, 2017

Primary Completion

March 18, 2018

Study Completion

March 18, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations