Citation

Newman ANL, Beauchamp MK, Ellerton C, Goldstein R, Alison JA, Dechman G, Haines KJ, Harrison SL, Holland AE, Lee AL, Marques A, Spencer L, Stickland MK, Skinner EH, Camp PG, Kho ME, Brooks D. Trials 2024; 25(1): e487.

Copyright

(Copyright © 2024, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s13063-024-08251-1

PMID

39020430

PMCID

PMC11256496

Abstract

BACKGROUND: Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials.

METHODS: This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned.

RESULTS: Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study.

CONCLUSIONS: We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.

Language: en

Keywords

Humans; Incidence; Research Design; Retrospective Studies; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Multicenter Studies as Topic; *Accidental Falls/prevention & control; *Postural Balance; *Pulmonary Disease, Chronic Obstructive/rehabilitation/diagnosis/epidemiology; Balance training; Chronic obstructive pulmonary disease (COPD); Exercise Therapy/methods; Project management; Pulmonary rehabilitation; Randomized controlled trial