Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
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BACKGROUND: Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS: We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS: Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15 months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS: Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.
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DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
- Date Crossref
- 28/08/2019
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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St. Joseph’s Healthcare Hamilton pays non établi dans la noticeÉtablissement de santé
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Health Sciences Centre Department of Health Research Methods pays non établi dans la noticeÉtablissement de santé
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Impact pays non établi dans la noticeOrganisation à but non lucratif
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McMaster University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Juravinski Hospital pays non établi dans la noticeÉtablissement de santé
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Hamilton General Hospital pays non établi dans la noticeÉtablissement de santé
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Toronto General Hospital pays non établi dans la noticeÉtablissement de santé
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University of Toronto Department of Physical Therapy pays non établi dans la noticeUniversité ou école supérieure
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Toronto Rehabilitation Institute pays non établi dans la noticeÉtablissement de santé
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St. Michael's Hospital pays non établi dans la noticeÉtablissement de santé
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Ottawa Hospital pays non établi dans la noticeÉtablissement de santé
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Western University Department of Medicine and Department of Epidemiology and Biostatistics pays non établi dans la noticeUniversité ou école supérieure
St. Joseph’s Healthcare Hamilton, Department of Health Research Methods — Health Sciences Centre et Impact, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.