Time and Motion Studies: Opportunities and Challenges
Time and motion studies can be a useful way to gather real world evidence of a medical intervention's value.
When the efficiency of a drug, medical device, or intervention is the outcome of interest, time and motion studies may be warranted to collect evidence of "value". Time and motion studies are designed to collect observational data to quantify the impact of medical interventions on dynamics of patient and staff movement through the healthcare facility as well as the resources consumed along the way. Data obtained may inform activity-based costing and healthcare management by facility administrators,1 but also inform health economic analyses, including models to quantify facility efficiency, patient throughput, budget impact, etc.
In the context of limited healthcare budgets, facility administrators are under increasing pressure to identify the precise staffing needs and required equipment and resources that optimise both patient care and net income. Moreover, as regulatory processes associated with the development and launch of medical products and devices become more stringent, the need for real-world effectiveness and efficiency data in support of these new and emerging products becomes increasingly important.
Timing is everything...Time and motion methodology consists of breaking down a process into its constituting tasks and observing and recording time for tasks repeatedly. It employs direct on-site observation using manual timing techniques. Frequently, hand-held stop watches are used by observers, who are not part of the usual care team, to measure how long pre-identified tasks take to complete and, in some cases, in which order they occur. Resources allocated or consumed in relation to patient care can also be carefully documented along the way. Although wholly naturalistic and prospective, the inherent focus on movement and multiple events performed by multiple people, all in real-time, contribute to both the uniqueness and associated challenges of this type of observational study. In contrast to prospective designs that employ interviews or questionnaires to gather data, data quality control in time and motion studies is much more difficult to establish, unless the process is filmed; there is seldom, by design, a source document to refer back to. Practised and well-trained observers, quick on their feet and attuned to care provision, are therefore essential components of a successful time and motion study.
The following additional design and process elements which contribute to a successful Time and Motion study are worth noting.
• Strategic evidence matters. Early thoughts about which evidence is required for which audience, potential publication strategy, need for a descriptive vs. an analytical design (to test a hypothesis of a time difference between comparator processes) are all crucial in order to build a scientifically robust study, Also, if it is intended that study data will populate an economic model, it is critical that study variables map precisely to model data requirements. While this seems intuitive, close monitoring of the evolution of the economic model and study design is essential as these are both dynamic development processes and it is likely that different teams of researchers are involved as different expertise is required.
• Less is more. Study variables must be carefully scrutinised to ensure that only the variables of utmost importance are included in the case report form (CRF). It is advisable to exclude from the CRF activities that happen infrequently or that are intertwined with other activities of less importance. The fewer the number of variables, the more likely that valid and complete study data will result.
• Keep it simple. The CRF that observers will use to record their data must be user-friendly. The formats should be designed with the predicted chronological order of healthcare events and resource utilisation of interest in mind, along with the awareness that observers are likely juggling a writing instrument, a stop-watch, and a CRF.
• Find the common ground. Each task to be measured should be described on the CRF in the most accurate way, providing a clear and unambiguous indication of when to start and stop the clock. Especially in multi-country and multi-centre time and motion studies, one should ensure that the activity definitions are applicable across all sites, despite highly variable facility types and local care processes. A common CRF is paramount for efficient and meaningful data analyses, especially when data needs to be pooled.
• Invest in local leadership. It is essential that participating study sites offer both a principal investigator and study nurse who are engaged and committed to the day-to-day management of the study. While patients may be pre-identified from facility schedules for enrollment into the study, the precise time of the observation period will probably not be known until the day of the treatment or procedure. Also, last-minute changes to the healthcare staff on duty, as well as appointment delays and cancellations, are common occurrences in real-world practice; thus, spontaneity, practicality, and common sense must prevail on observation days. It is essential that a seasoned study nurse, well-trained by the study design team, leads this effort.
• Training is the key to success. Observer training that is standardised across all participating centres helps to mitigate potential inter-observer variability in stopwatch measurement. This is achieved through the provision of detailed instructions for site study staff and observers alike, as well as on-site training at the actual facility, in the treatment or procedure rooms where the observations will ultimately take place. A pilot observation during training is recommended to confirm that the task descriptions are aligned with local site practice, and that observers are comfortable measuring time and completing the form.
• Team play - know your collaborators. At the beginning of each observation day, if feasible, it is suggested that observers meet the healthcare staff that will be providing care to the study subjects that day. This provides an opportunity for observers to pre-identify the role each healthcare staff plays on the care team. This familiarisation can contribute directly to the accuracy of timings that need to be recorded by the observers.
• Don't let the data get cold. Data should be processed immediately so that any gaps in the data can be communicated back to the observer or site-based study nurse within a reasonable recall period. Innovative approaches to communicating information to the study co-ordinating centre, such as the use of tablet PCs to record study data, can dramatically reduce the time required for data processing and management.
• Chose the right data analytic technique. Data can be analysed at different levels: centre, country, and pooled across countries. Sophisticated statistical techniques may be needed to test and correct for centre clustering of data, or to identify and adjust for relevant co-variates or predictors of time. Time data could be analysed for individual tasks, to be subsequently combined to estimate total process time, or total "per case" time could be analysed as a single variable.
The main limitations of Time and Motion studies include risk of observers interfering with care patterns by their presence (i.e., Hawthorne Effect) and the precision of the study data given the possibility of human timing errors. Moving through time and space, while juggling a stopwatch, pen, and CRF, is indeed a challenge for the observers charged with the mandate to produce complete and high quality data. With a thoughtful design, careful planning, and an experienced study team, however, these studies can, nevertheless, result in meaningful and valid data that allow unlocking the value of efficiency from the perspective of a variety of stakeholders (patients, healthcare professionals, facility administrators, and payers). While these studies are generally more complex with respect to logistics, there is an opportunity within Time and Motion research to be creative and innovative in both the delineation of the data points of interest, as well as the observation and data gathering techniques employed. Despite these challenges, those responsible for the empirical quantification of efficiency-related outcomes in support of a medication or medical device are encouraged to consider this approach to evidence generation. It just may be that the time is now.
About the authors:
Erwin De Cock, MSc, Scientific Consultant, United BioSource Corporation
Erwin is a Scientific Consultant and Health Economist for the Value Demonstration team at United BioSource Corporation (UBC). During his time at UBC (since 2000), he has built up expertise in the design of real-world data collection studies, with a focus on medical chart reviews, time and motion studies, and physician and patient surveys. His pharmacoeconomic background includes the development of decision-analytic and budget impact models, cost-effectiveness analyses, cost-of-illness, and micro-costing studies. More recently, Erwin has been responsible for conceptualising and overseeing large multinational time and motion studies alongside clinical trials, covering more than 20 countries across Europe, North America, and South America.
Karen Yeomans, BSc, Senior Manager & Senior Research Scientist, United BioSource Corporation
Karen is a Senior Manager and Senior Research Scientist at United BioSource Corporation. She has a keen interest in burden of illness evaluations, both from study design and project management perspectives, as well as hands-on experience in the design and implementation of time and motion studies. She has successfully managed national and international health economics and outcomes research projects, including multinational chart review studies, time and motion studies, and both cross-sectional and longitudinal studies of patient-reported outcomes.
For more information on United BioSource Corporation, visit www.UBC.com
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