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

NCT04249141 | Withdrawn

• 1 other identifier: 1R01HL146781-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ABCDEF bundle performance

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

  2 years

Secondary Outcomes (1)

• Implementation strategies

  2 years

Study Arms (2)

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

Survey and concept mapping OTHER

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

ICU providers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Did not participate in ICU Liberation Collaborative efforts

Sponsors & Collaborators

• Ohio State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Society of Critical Care Medicine: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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.

  PMID: 31825508 BACKGROUND

• 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.

  PMID: 30339549 BACKGROUND

MeSH Terms

Conditions

Delirium; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michele C Balas, PhD

  OSU CON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 28, 2020
• Primary Completion: March 30, 2023
• Study Completion: July 31, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: when study complete
• Access Criteria: 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.

Locations

US (1)