Open AccessDisinvestment in the presence of uncertainty: Description of a novel, multi-group, disinvestment trial design and protocol for an application to reduce or cease use of mobilisation alarms for preventing falls in hospitals
Author(s) -
Terrence Peter Haines,
Mari Botti,
Natasha K. Brusco,
Lisa O’Brien,
Bernice Redley,
KellyAnn Bowles,
Alison Hutchinson,
Debra Mitchell,
Joanna Jellett,
Kate Steen,
Leanne Boyd,
Melinda WebbSt Mart,
Melissa Raymond,
Peter Hunter,
Philip L. Russo,
Rachel Bonnici,
Dandan Pu,
Samantha Sevenhuysen,
Vicki Davies,
Ronald I. Shorr
Publication year - 2021
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0261793
Subject(s) - disinvestment , medicine , randomized controlled trial , protocol (science) , cluster randomised controlled trial , psychological intervention , operations management , nursing , economics , alternative medicine , incentive , surgery , pathology , microeconomics
Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a “Reduced” (<3%) or “Eliminated” (0%) mobilisation alarm condition. Dynamic randomisation will be used to determine which ward in each pair will be allocated to either the reduced or eliminated condition to promote equivalence between wards for the embedded parallel, cluster randomised component of the design. A project governance committee will set non-inferiority margins. The primary outcome will be rates of falls. Secondary clinical, process, safety, and economic outcomes will be collected and a concurrent economic evaluation undertaken.