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WithdrawnNCT04249141DISCOVER-ICUUpdated Aug 16, 2023

Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts

An observational study in Implementation Science, Delirium and Intensive Care Unit Acquired Weakness, sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by Ohio State University · Observational

Why this study was withdrawn
Participants were not assigned to an intervention and as such this was not considered a clinical trial.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
0
Ages
18 Years to 100 Years
Sex
All
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Study summary

There is a fundamental gap between the discovery of proven-effective intensive care unit (ICU) sedation, mechanical ventilation, mobility, and symptom management strategies and approaches that can equip ICU providers with the skills necessary to reliably adopt these interventions in everyday practice. Until this gap is filled, the millions of patients with heart, lung, and blood disorders admitted to ICUs annually will remain at risk for avoidable physical, mental, and cognitive health impairments that may persist for months to years after hospital discharge. In the proposed study, the investigative team will continue their partnership with the Society of Critical Care Medicine's (SCCM's) ICU Liberation Collaborative. Guided by the Consolidated Framework for Implementation Research, the overall objective of the Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts in the ICU (DISCOVER-ICU) study is to develop multilevel implementation strategies to enhance sustainable adoption of the ABCDEF (Assess, prevent, and manage pain and delirium, both spontaneous awakening and breathing trials, choice of sedation, early mobility, family engagement) bundle in routine ICU practice. Using a multiphase, sequential, mixed-methods design, this study has three specific aims: 1) estimate the effects of patient-level characteristics on ABCDEF bundle adoption; 2) examine unit-level variation in ABCDEF bundle adoption and associated provider- and organization-level characteristics; and 3) determine which implementation strategies result in the greatest adoption of the ABCDEF bundle. Existing deidentified data will be obtained from >15,000 patients, >5,000 interprofessional ICU team members, and 68 hospitals participating in the ICU Liberation Collaborative to achieve specific aims 1 and 2. For specific aim 3, data collection will be extended using interprofessional ICU team surveys, a modified Delphi process, and concept mapping to achieve greater understanding of implementation strategies that prove most effective for ABCDEF bundle adoption. Results of this work will directly lead to the development of implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase ABCDEF bundle adoption. These implementation strategies will then be tested in a future cluster randomized hybrid II implementation effectiveness trial.

Read the detailed description

Patients with heart, lung, and blood disorders severe enough to require an intensive care unit (ICU) stay frequently experience profound physical, mental, and cognitive health impairments that may persist for months to years after hospital discharge. These long-term impairments are commonly acquired in the ICU and are often initiated or exacerbated by sedation, mechanical ventilation, and symptom management decisions. Indeed, ICU-acquired pain, anxiety, delirium, and weakness are associated with numerous adverse health outcomes including prolonged mechanical ventilation, post-traumatic stress disorder, depression, functional decline, new institutionalization, and severe neurocognitive impairment. Considering millions of adults face the challenges of ICU survivorship annually, it is essential findings from high-quality research are reliably adopted and sustained in everyday clinical practice.

As outlined in "Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium (PAD) in Adult Patients in the ICU," a robust and growing body of evidence demonstrates clinical outcomes are improved when integrated, interprofessional approaches to mechanical ventilation and symptom management are applied during the course of critical illness. One such approach is the ABCDEF bundle, an evidence-based, multicomponent strategy that incorporates many PAD guideline recommendations. While previously shown safe and effective when applied in routine ICU practice, the investigators preliminary data demonstrate that this bundle has yet to be widely adopted. Pain and delirium remain underdiagnosed, and ICU clinicians often fail to maintain patients at a light level of sedation, use a protocolized mechanical ventilation discontinuation approach, get patients out of bed, or accept flexible bedside family presence. There is, therefore, a clear need for studies that use validated implementation frameworks and outcomes to assess strategies for improving ABCDEF bundle adoption and the removal of long-held and potentially harmful ICU practices.

In the proposed study, the investigators will continue their three-year partnership with the Society of Critical Care Medicine's ICU Liberation Collaborative, a national quality improvement (QI) network comprised of 68 ICUs. Guided by the Consolidated Framework for Implementation Research, the overall objective of this T4 research is to develop multilevel implementation strategies to enhance sustainable adoption of the ABCDEF bundle in routine ICU practice. The investigators are particularly interested in discovering how various patient-, provider-, and organization-level characteristics and implementation strategies effect ABCDEF bundle adoption. Using a multiphase, sequential, mixed-methods design the "Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts in the ICU (DISCOVER-ICU)" study has three specific aims:

Aim 1: Estimate the effects of patient-level characteristics on ABCDEF bundle adoption. Patient-level characteristics are defined as non-modifiable factors exhibited by critically ill adults at ICU admission that may influence ABCDEF bundle adoption. Existing data on ≥ 15,000 critically ill adults who spent at least one full day in a participating ICU Liberation Collaborative unit will be used to estimate the effects of: (1) demographics, (2) body mass index, (3) admitting diagnosis, (4) severity of illness, and (5) preadmission residence/mobility status on ABCDEF bundle adoption. The hypothesis is that the ABCDEF bundle will less likely be adopted into the care of particularly vulnerable populations (e.g., older adults, obese, non-English speaking).

Aim 2: Examine unit-level variation in ABCDEF bundle adoption and associated provider- and organization-level characteristics. Existing data will be obtained from surveys of over 5,000 interprofessional ICU team members and 68 hospitals participating in the ICU Liberation Collaborative. Provider-level characteristics are defined as ICU clinicians': (1) ABCDEF bundle-related knowledge and attitudes, (2) self-efficacy, and (3) perceptions of work environment (both overall health and degree of teamwork/collaboration). Organization-level characteristics are defined as those related to: (1) administrative structure, (2) staffing patterns, (3) ICU team composition, and (4) prior QI experience. The hypothesis is that ABCDEF bundle adoption will be greater in ICUs where providers value and are more familiar with the principles of the bundle, display higher levels of self-efficacy, and report more positive teamwork. Secondly, there will be better bundle adoption in organizations with greater absorptive capacity for change, more resources, and who use interprofessional ICU team models.

Aim 3: Determine which implementation strategies result in the greatest adoption of the ABCDEF bundle. Data collection will be extended by using interprofessional ICU team surveys, a modified Delphi process, and concept mapping to achieve greater understanding of implementation strategies that prove most effective for ABCDEF bundle adoption. The focus on high- and low-ABCDEF bundle-performing units will allow the investigative team to select and tailor potential ABCDEF bundle implementation strategies to meet specific local contextual needs.

With expertise in dissemination and implementation science, biostatistics, critical care, and QI, the interdisciplinary team investigative is ideally prepared to lead this three-year study. The results will directly lead to the development of implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase ABCDEF bundle adoption. These implementation strategies will then be tested in a future cluster randomized hybrid II implementation-effectiveness trial.

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Conditions studied

  • Implementation Science
  • Delirium
  • Intensive Care Unit Acquired Weakness
  • Pain
  • Sedation Complication
  • Mechanical Ventilation Complication

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03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

Browse Delirium studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

_Preexisting data on patients, providers, and hospitals participating in ICU Liberation Collaborative

-Prospectively collected data from ICU RN, MDs, Respiratory/Physical/Occupational Therapist, Pharmacist who was responsible for ABCDEF bundle implementation efforts associated with SCCM ICU Liberation Collaborative

Inclusion criteria

  • ICU patient who was enrolled in ICU Liberation Collaborative (preexisting data)
  • ICU provider or organization who participated in ICU Liberation Collaborative (preexisting data)
  • ICU provider who was responsible for ABCDEF bundle implementation efforts associated with SCCM ICU Liberation Collaborative (prospective collected data)

Exclusion criteria

Exclusion Criteria:

  • Did not participate in ICU Liberation Collaborative efforts
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU providers

    Surveys and a concept mapping exercise will be administered to ICU providers who participated in the ICU Liberation Collaborative

    Other: Survey and concept mapping

  • Secondary Data Analysis

    Secondary data analysis will used information on patients and providers who participated in the ICU Liberation Collaborative

Interventions

  • OtherSurvey and concept mapping

    ICU providers who participoated in SCCM ICU Liberation Collaborative will be invited to participate in surveys and a concept mapping excercise

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What researchers measure

Primary outcomes

  1. ABCDEF bundle performance

    complete, proportional, and individual bundle element performance as defined in prior investigations

    Time frame: 2 years

Secondary outcomes

  1. Implementation strategies

    Strategies used to facilitate ABCDEF bundle adoptions as defined in the Erik Project

    Time frame: 2 years

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Study locations

1 site
  • The Ohio State University College of Nursing
    Columbus, Ohio 43210, United States
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References and documents

Publications

  • Kruser JM, Aaby DA, Stevenson DG, Pun BT, Balas MC, Barnes-Daly MA, Harmon L, Ely EW. Assessment of Variability in End-of-Life Care Delivery in Intensive Care Units in the United States. JAMA Netw Open. 2019 Dec 2;2(12):e1917344. doi: 10.1001/jamanetworkopen.2019.17344. PubMed 31825508 ↗
  • Pun BT, Balas MC, Barnes-Daly MA, Thompson JL, Aldrich JM, Barr J, Byrum D, Carson SS, Devlin JW, Engel HJ, Esbrook CL, Hargett KD, Harmon L, Hielsberg C, Jackson JC, Kelly TL, Kumar V, Millner L, Morse A, Perme CS, Posa PJ, Puntillo KA, Schweickert WD, Stollings JL, Tan A, D'Agostino McGowan L, Ely EW. Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collaborative in Over 15,000 Adults. Crit Care Med. 2019 Jan;47(1):3-14. doi: 10.1097/CCM.0000000000003482. PubMed 30339549 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 30, 2022
  • Informed consent form · Jul 19, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Study data will be made available to researchers upon request after analyses of specific aims have been conducted and findings have been published. In order to protect the privacy of individuals and institutions, as well as the confidentiality of hospitals, units and research participants, no identifying information will be collected or shared in this research endeavor. Persons interested in using the data will need to submit a request in writing, stating their intended use. Requirements for sharing will include acknowledgement in all publications of the funding source and of the study authors. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. The most cost-effective means for sharing data will be considered after a data-sharing agreement has been reached. Research findings will also be shared through publications and presentations at scholarly research meetings.

Supporting information: Study protocol, Sap, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04249141
Lead sponsor
Ohio State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Society of Critical Care Medicine, Vanderbilt University Medical Center
Responsible party
Michele Balas (Associate Dean of Research, University of Nebraska) — Principal investigator
First posted
Jan 30, 2020
Start date
Jan 28, 2020
Primary completion
Mar 30, 2023
Completion
Jul 31, 2023
Last update
Aug 16, 2023

Study contacts

Michele C Balas, PhD
principal investigator · OSU CON

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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