Neuromuscular BlockadeNCT03179709
Provider Perceptions of Neuromuscular Blockade in ARDS
An observational study of Neuromuscular Blockade and Acute Respiratory Distress Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Acute Respiratory Distress Syndrome
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 18 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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.
- Being tested
- Interview
- Keywords
- Acute Respiratory Distress Syndrome, Neuromuscular Blockade, Interviews, Implementation Science
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
The investigators will perform and analyze semi-structured interviews with enrolled participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interview | |
| Refusal | The investigators will interview physicians who have refused to allow their patients to be enrolled in ROSE. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion18 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeremy Kahn, University of Pittsburgh
- Investigators
- Jeremy M Kahn, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179709
- Sponsor's protocol ID
- 170115
- Other IDs
- U01HL123020
- Status last verified
- Jan 2020
- First submitted
- 31 May 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Perceptions of Neuromuscular Blockade in ARDS
- ClinicalTrials.gov ID
- NCT03179709
- Acronym / sponsor ID
- 170115
- Keywords
- Acute Respiratory Distress Syndrome, Neuromuscular Blockade, Interviews, Implementation Science
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: InterviewThe investigators will interview physicians, nurses, respiratory therapists and other clinicians who have cared for patients enrolled in the active treatment arm of ROSE. |
| Control | – | Behavioral: InterviewThe investigators will interview physicians, nurses, respiratory therapists and other clinicians who have cared for patients enrolled in the control treatment arm of ROSE. |
| Refusal | – | Behavioral: InterviewThe investigators will interview physicians who have refused to allow their patients to be enrolled in ROSE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewThe investigators will perform and analyze semi-structured interviews with enrolled participants. | Behavioural | Control, Intervention, Refusal |
Primary outcome
Barriers to adoption of NMB
Time frame: 1 month post enrollment
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.
Contextual factors that influence the effectiveness of NMB
Time frame: 1 month post enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy M Kahn, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Acute Respiratory Distress Syndrome, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to adoption of NMB (time frame: 1 month post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.