The trial protocol described by Ford et al1 should inspire awe in implementation scientists and perhaps a little bit of envy. The Improving Management of Urinary Tract Infections in Nursing Institutions Through Facilitated Implementation (IMUNIFI) Study will be a cluster randomized trial of an antibiotic stewardship bundle for urinary tract infection (UTI) in 20 or more nursing homes. The investigators are tackling a major question in an area of considerable clinical importance: how does one best implement antibiotic stewardship interventions in nursing homes? They will explore this question by combining 3 implementation strategies: external facilitation, peer-learning collaboratives, and peer comparison feedback. This enhanced implementation approach will be compared with usual implementation, which consists of a kickoff meeting followed by unlimited online access to the toolkit and training resources. All sites in both groups will be required to input data through a web-based portal on a monthly basis. The 2 primary clinical outcome measures are well-defined: (1) number of urine cultures and (2) antibiotic prescriptions for suspected UTI, both standardized by resident-days. The investigators require nursing homes to submit 3 months of baseline data prior to randomization, thus ensuring all sites are engaged and capable of collecting study data. Appropriate balancing measures are in place, tracking number of transfers to hospitals or emergency departments and also the number of resident deaths. The study will measure key implementation outcomes related to toolkit adoption through surveys, participation in coaching calls, and qualitative interviews. In terms of quality, this study is truly the Cadillac of antibiotic stewardship implementation trials.
This Cadillac project comes with all sorts of upgrades. The implementation toolkit is already available, developed with stakeholder input using an expert Delphi panel approach.2 The toolkit’s 5 modules provide interactive learning through slide sets, videos, brochures, data-tracking tools, case studies, and educational resources. The multidisciplinary implementation team includes physicians, nurses, social workers, and implementation scientists. Interpretation of the qualitative findings will be guided by an established implementation model. And, perhaps most importantly, the project is funded through the research foundation of an academic institution, thus ensuring that time and resources are available to execute work proposed.
If this project succeeds, what will we learn? Virtual breakthrough series, also known as peer-learning collaboratives, are a widely used model for quality improvement.3 However, whether they are more effective than simply providing a toolkit and making technical assistance available has not been determined rigorously.3 Coaching, or external facilitation, is often offered through these collaboratives, and some collaboratives also provide feedback on outcomes, as proposed in this trial protocol. The IMUNIFI trial will study whether the combination of all 3 (collaborative, coaching, and feedback) is more effective at implementing antibiotic stewardship for UTI in long-term care than providing a toolkit plus a question-and-answer line. Furthermore, the investigators will assess facility-level adoption of the intervention through surveys and interviews, enabling them to relate the level of adoption to clinical outcomes. These study results will inform applications to other health care settings and quality improvement interventions.
On the other hand, success of this project will still leave important implementation questions unanswered. As the intervention is a bundle of implementation techniques and the design is a cluster randomized trial (in contrast to a step-wedge design), we will not know which of these led to success, or whether all 3 need to be implemented together. A single download of a web-based toolkit module can be used to train 1 staff member or 200 staff members, so precise information on use of the various modules will not be available. Furthermore, the project is not designed to measure sustainability of the stewardship effect. This is an important limitation, as regression to the mean is a frequent issue with systems-level interventions.
What if this project fails to find improved clinical outcomes in either group? Even a negative answer can provide valuable information. Qualitative interviews will provide insights into barriers and facilitators of implementation. Thus, if the project is hampered by the known information technology shortcomings in nursing homes (eg, lack of computer access), this challenge will be named and known.
The potential flaw in the design of this Cadillac study is the level of complexity of the algorithm and of the intervention. The toolkit has 5 modules, each with multiple components. Web-based data submission is required from each participating nursing home, and the staff member responsible for implementation at each site will need to review whether urine cultures and antibiotic prescriptions meet appropriateness criteria. The decision-support algorithm that is the crux of the intervention is also complex, leading to 4 possible pathways for subsequent action,2 thus creating cognitive load for the clinician applying the algorithm at the point of care.
Health care professionals face myriad decisions in the course of a day of clinical care, while juggling demands for their time and attention. The complexity of clinical practice guidelines can hinder their adoption into practice, and the complexity of multicomponent interventions are a barrier to adoption into routine care.4 Many advocate for simple “fast and frugal”4 algorithms that substitute correct cues for incorrect cognitive biases, thus leading to better outcomes without incurring the time costs of a mindful pause. Pragmatic and limited implementation programs have also been suggested as a strategy for success in complex health care environments with rapid turnover of personnel, as is the case in many nursing homes.4 Fortunately, the IMUNIFI qualitative interviews will provide insights into whether complexity becomes an obstacle to implementation in long-term care. At the time of study completion, valuable information can be gained from taking a look back and comparing what the investigators planned to do vs what the intervention sites actually did.
Even if IMUNIFI does not succeed in changing clinical outcomes, it will provide new evidence about what contributes to a successful antibiotic stewardship intervention—evidence that is badly needed.5 Quality improvement projects, in contrast to this research project, are typically underfunded and performed without additional investment in personnel time. Outcomes are partially captured, and findings are often not generalizable. If this research trial is the Cadillac of antibiotic stewardship projects, then quality improvement antibiotic stewardship projects are the no-frills Camry models. Evidence from this Cadillac stewardship project will shape and inform countless subsequent quality improvement projects. And eventually those Camry quality improvement projects will get us where we need to go, to more judicious antibiotic use for suspected UTI in nursing homes.
Published: September 11, 2019. doi:10.1001/jamanetworkopen.2019.9515
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2019 Trautner BW et al. JAMA Network Open.
Corresponding Author: Barbara W. Trautner, MD, PhD, Center for Innovations in Quality, Effectiveness, and Safety (IQuESt) (152), Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd, Houston, TX 77030 (email@example.com).
Conflict of Interest Disclosures: Dr Trautner reported grants from Zambon Pharmaceuticals, the Agency for Healthcare Research and Quality, the Roderick Duncan MacDonald Research Fund, US Department of Veterans Affairs Health Services Research & Development, and US Department of Veterans Affairs Rehabilitation Research and Development Merit Review outside the submitted work. No other disclosures were reported.
Funding/Support: This material is based on work supported in part by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, and the Center for Innovations in Quality, Effectiveness and Safety (grant CIN 13-413).
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the US government.
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Trautner BW, Naik AD. Taking a Ride on the Stewardship Side of Long-term Care: The Cadillac and the Camry. JAMA Netw Open. Published online September 11, 20192(9):e199515. doi:10.1001/jamanetworkopen.2019.9515
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