Cluster Trial Targets a Longstanding Gap in Orthopaedic Bladder Care
The OPTION trial is built around a familiar but still poorly controlled problem in orthopaedic wards: urinary retention after hip surgery. In hospital settings, bladder dysfunction can follow anesthesia, immobility, opioid exposure, and perioperative fluid shifts, and if retention goes unrecognized it can progress to painful overdistension, infection, prolonged catheterization, and in some cases lasting voiding injury. The protocol is not testing a new drug or device. It is testing whether a structured implementation strategy can move evidence-based bladder monitoring from paper recommendations into routine care across orthopaedic sites.
The trial’s premise is direct. Clinical guidelines already exist, yet implementation remains uneven. In practice, that gap can leave patients vulnerable to delayed bladder scans, inconsistent postvoid assessment, and management routines that drift away from evidence. The investigators are trying to close that gap by pairing frontline nursing and rehabilitation staff with first-line managers in a coordinated local facilitator model.
How the Implementation Strategy Is Built
Twenty orthopaedic sites are cluster randomized into intervention and control groups. The intervention sites form local facilitator teams drawn from nursing and rehabilitation staff, with first-line managers included in the structure from the start. Over 12 months, those teams receive support through face-to-face events and on-demand components designed to identify barriers, map local workflow problems, and replace unproductive routines with guideline-based bladder care.
The operational logic is simple and clinically plausible. Urinary retention is not usually caused by a single failure. It emerges when staff roles are unclear, monitoring is inconsistent, and escalation pathways are slow or fragmented. A team-based implementation design attempts to correct those weak points by changing behavior at the point of care rather than relying on passive distribution of a guideline. Leadership behavior is also part of the intervention, which matters because ward-level practice change often depends on whether managers actively support new routines or allow older habits to persist.
One sentence captures the central bet of the study: evidence is not the same thing as implementation.
What the Trial Will Measure in Hip Surgery Patients
Baseline data collection is broad and intentionally practical. Patient records will be reviewed for urinary retention procedures, the incidence and severity of voiding problems, and related complications. Staff and managers will be interviewed, and all hip surgery patients across the sites will be surveyed, with interviews added at every site. The study also incorporates contextual measurement, using the Alberta Context Tool with staff and the 4Ps tool for preference-based patient participation with patients.
That design gives the trial more than a before-and-after snapshot. It creates a layered picture of how bladder care functions inside real orthopaedic services: the written protocol, the staff environment, the patient experience, and the resource demands tied to urinary bladder care. Economic data are included as well, which is especially relevant because implementation programs are often judged not only by whether they improve care, but by whether they do so in a way that can be absorbed into routine hospital work.
During the intervention phase, every event will be recorded and facilitators will keep diaries. Those records should help identify which support activities are actually used, where implementation stalls, and how local teams respond when they encounter obstacles in daily practice. After the intervention, the same data collections will be repeated twice, with additional attention to participant experiences of the intervention and the process of guideline implementation.
Why This Matters for Orthopaedic Nursing and Rehabilitation
Hip surgery patients occupy a high-risk zone for urinary complications because postoperative bladder function is sensitive to anesthesia, pain control, mobility limitations, and the timing of catheter removal. When monitoring is inconsistent, retention may be missed until the bladder is already overdistended, a point at which recovery becomes more difficult and complications become more likely. In that sense, the trial sits at the intersection of nursing workflow, rehabilitation timing, and patient safety.
The intervention also asks a larger implementation question: how do dyads of facilitators and first-line managers alter routine care in a hospital system where the evidence is already available? Leadership is not a background variable here. It is part of the mechanism of change. If managers support staff ownership of the protocol, reinforce new routines, and help remove local barriers, the odds of durable practice change improve. If they do not, even well-designed guidelines can remain underused.
For patients, the bedside consequence is concrete. Better bladder monitoring may mean earlier detection of retention, fewer unplanned catheterizations, and fewer voiding complications after surgery. For staff, the change may mean clearer decision pathways and less reliance on habit-based care.
Mixed-Methods Analysis Will Link Outcomes to Workflow Change
The statistical plan includes comparisons before and after the intervention and between intervention and control sites. Qualitative data will be examined using content analysis, and the study uses mixed methods to connect clinical outcomes with process evaluation in a hybrid design. That structure is appropriate for an implementation trial because outcome differences alone rarely explain why one site changes and another does not.
The protocol does not promise a specific effect size, and it does not need to. Its value lies in whether the intervention changes bladder care processes in a measurable way and whether those changes can be traced back to identifiable barriers, enablers, and leadership behaviors. If the trial succeeds, it may provide a workable model for translating other orthopaedic guidelines into practice, especially in settings where urinary retention remains common despite clear evidence.
Registration and Trial Timing
The study was registered as NCT04700969 with the U.S. National Institutes of Health Clinical Trials Registry on 8 January 2021, before baseline data collection began. That timing strengthens the transparency of the protocol and provides a clear public record of the planned intervention and analyses.
The remaining question is not whether urinary retention matters. It does. The unresolved issue is whether a structured facilitator-and-manager model can reliably close the gap between guideline availability and bedside practice in orthopaedic care.