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Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial

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, n...

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Published in:Current controlled trials in cardiovascular medicine 2019-08, Vol.20 (1), p.532-532, Article 532
Main Authors: McCaskell, Devin S, Molloy, Alexander J, Childerhose, Laura, Costigan, F Aileen, Reid, Julie C, McCaughan, Magda, Clarke, France, Cook, Deborah J, Rudkowski, Jill C, Farley, Christopher, Karachi, Tim, Rochwerg, Bram, Newman, Anastasia, Fox-Robichaud, Alison, Herridge, Margaret S, Lo, Vincent, Feltracco, Deanna, Burns, Karen Ea, Porteous, Rebecca, Seely, Andrew J E, Ball, Ian M, Seczek, Amy, Kho, Michelle E
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cited_by cdi_FETCH-LOGICAL-c560t-1b4c8c17c4676832e7615d728441322ad509d4ad10d1bf98b7fb85f5908422a3
cites cdi_FETCH-LOGICAL-c560t-1b4c8c17c4676832e7615d728441322ad509d4ad10d1bf98b7fb85f5908422a3
container_end_page 532
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container_start_page 532
container_title Current controlled trials in cardiovascular medicine
container_volume 20
creator McCaskell, Devin S
Molloy, Alexander J
Childerhose, Laura
Costigan, F Aileen
Reid, Julie C
McCaughan, Magda
Clarke, France
Cook, Deborah J
Rudkowski, Jill C
Farley, Christopher
Karachi, Tim
Rochwerg, Bram
Newman, Anastasia
Fox-Robichaud, Alison
Herridge, Margaret S
Lo, Vincent
Feltracco, Deanna
Burns, Karen Ea
Porteous, Rebecca
Seely, Andrew J E
Ball, Ian M
Seczek, Amy
Kho, Michelle E
description 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. 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. 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. 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. ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.
doi_str_mv 10.1186/s13063-019-3634-7
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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. 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. 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. 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. ClinicalTrials.gov, NCT02377830 . 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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. ClinicalTrials.gov, NCT02377830 . 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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. 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. 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. 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. ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>31455384</pmid><doi>10.1186/s13063-019-3634-7</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0003-3170-031X</orcidid><oa>free_for_read</oa></addata></record>
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ispartof Current controlled trials in cardiovascular medicine, 2019-08, Vol.20 (1), p.532-532, Article 532
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1745-6215
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subjects Analysis
Behavior modification
Clinical trials
Consent
Correspondence
Critical care
Data Collection
Data entry
Employee turnover
Endpoint Determination
Ethics
Hospitals
Humans
Intensive care
Intervention
Investigations
Leaves of absence
Management techniques
Methodology
Multicenter Studies as Topic - methods
Novels
Patient Selection
Personnel Staffing and Scheduling - organization & administration
Physical therapy
Pilot Projects
Planning
Project management
Randomized controlled trial
Randomized Controlled Trials as Topic - methods
Rehabilitation
Research Design
Research ethics
Research Personnel - organization & administration
Retrospective Studies
Shortages
Time Factors
Trial management
Ventilators
Workflow
title Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
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